Obstetrics

Treatment with the antifungal agent terbinafine during pregnancy does not appear to increase the risk of major malformations or spontaneous abortions, according to results from a large registry study in Denmark.

digitalskillet/Thinkstock

Physicians have been reluctant to prescribe the drug during pregnancy because of the limited safety data. The drug has not been associated with any signs of fetal toxicity in animal studies, but only one study – in 54 pregnancies – has examined the issue in humans and did not identify an increased fetal risk, according to Niklas Worm Andersson, MD, of the department of clinical pharmacology, Copenhagen University Hospital at Bispebjerg and Frederiksberg, and coauthors.

The retrospective, nationwide cohort study analyzed exposure to oral and tropical terbinafine in a large pregnancy registry and found no increase in the risk of major malformations or spontaneous abortions in exposed versus unexposed pregnancies. The study was published in JAMA Dermatology.

Still, these results fell short of certainty, the authors noted. “Although our results may provide reassurance for pregnancies exposed to oral terbinafine by reporting no overall increased risk of major malformations, we cannot exclude a potential increased risk of a specific malformation,” they wrote.

“To our knowledge, this is by far the largest, most statistically rigorous study in the literature regarding this topic,” Jenny E. Murase, MD, of the department of dermatology at the University of California, San Francisco, and Mary Kathryn Abel, a medical student at UCSF, wrote in an accompanying editorial. They described the study as “a substantial contribution to the nearly absent literature regarding the use of terbinafine during pregnancy. Among the antifungal medications, it is possible that terbinafine is the safest one currently available for use in pregnancy, particularly of the oral formulations.”

However, since asymptomatic onychomycosis “is typically a cosmetic, rather than medical, concern, waiting until after pregnancy to initiate therapy is reasonable. ... It is important to acknowledge the uncertainty in this field and question the appropriateness of treating non–life-threatening diseases during pregnancy and lactation,” they wrote.

The Danish researchers drew from a registry of 1,650,649 pregnancies between 1997 and 2016, which included 891 pregnancies exposed to oral terbinafine, and 3,174 exposed to topical terbinafine. Matched outcome analyses compared the exposed pregnancies with up to 40,650 controls unexposed during pregnancy.

Propensity-matched comparisons showed no increased risk of major malformations for oral terbinafine exposure versus no exposure (odds ratio, 1.01; 95% confidence interval, 0.63-1.62) or topical exposure versus no exposure (OR, 1.08; 95% CI, 0.81-1.44). There was also no difference in oral versus topical exposure (OR, 1.18; 95% CI, 0.61-2.29).

iStock

With respect to spontaneous abortions, there was no significant association with oral terbinafine (hazard ratio, 1.06; 95% CI, 0.86-1.32) or topical terbinafine (HR, 1.04; 95% CI, 0.88-1.21), compared with unexposed pregnancies, or oral over topical terbinafine-exposed pregnancies (HR, 1.19; 95% CI, 0.84-1.70).

The study is limited by the fact that it was conducted in a Danish population, and the data relied on filled prescriptions for determining exposure, which did not account for adherence. Residual confounding is possible because of the retrospective nature of the study, the authors pointed out.

No source of funding was disclosed. One of the authors has received grants and personal fees from Novartis. Dr. Murase has received fees from Sanofi Genzyme, Dermira, UCB, Regeneron, Ferndale, and UpToDate.
 

SOURCES: Andersson NW et al. JAMA Dermatol. 2020 Mar 4. doi: 10.1001/jamadermatol.2020.0142; Murase JE, Abel MK. JAMA Dermatol. 2020 Mar 4. doi: 10.1001/jamadermatol.2019.5036.

Treatment with the antifungal agent terbinafine during pregnancy does not appear to increase the risk of major malformations or spontaneous abortions, according to results from a large registry study in Denmark.

digitalskillet/Thinkstock

Physicians have been reluctant to prescribe the drug during pregnancy because of the limited safety data. The drug has not been associated with any signs of fetal toxicity in animal studies, but only one study – in 54 pregnancies – has examined the issue in humans and did not identify an increased fetal risk, according to Niklas Worm Andersson, MD, of the department of clinical pharmacology, Copenhagen University Hospital at Bispebjerg and Frederiksberg, and coauthors.

The retrospective, nationwide cohort study analyzed exposure to oral and tropical terbinafine in a large pregnancy registry and found no increase in the risk of major malformations or spontaneous abortions in exposed versus unexposed pregnancies. The study was published in JAMA Dermatology.

Still, these results fell short of certainty, the authors noted. “Although our results may provide reassurance for pregnancies exposed to oral terbinafine by reporting no overall increased risk of major malformations, we cannot exclude a potential increased risk of a specific malformation,” they wrote.

“To our knowledge, this is by far the largest, most statistically rigorous study in the literature regarding this topic,” Jenny E. Murase, MD, of the department of dermatology at the University of California, San Francisco, and Mary Kathryn Abel, a medical student at UCSF, wrote in an accompanying editorial. They described the study as “a substantial contribution to the nearly absent literature regarding the use of terbinafine during pregnancy. Among the antifungal medications, it is possible that terbinafine is the safest one currently available for use in pregnancy, particularly of the oral formulations.”

However, since asymptomatic onychomycosis “is typically a cosmetic, rather than medical, concern, waiting until after pregnancy to initiate therapy is reasonable. ... It is important to acknowledge the uncertainty in this field and question the appropriateness of treating non–life-threatening diseases during pregnancy and lactation,” they wrote.

The Danish researchers drew from a registry of 1,650,649 pregnancies between 1997 and 2016, which included 891 pregnancies exposed to oral terbinafine, and 3,174 exposed to topical terbinafine. Matched outcome analyses compared the exposed pregnancies with up to 40,650 controls unexposed during pregnancy.

Propensity-matched comparisons showed no increased risk of major malformations for oral terbinafine exposure versus no exposure (odds ratio, 1.01; 95% confidence interval, 0.63-1.62) or topical exposure versus no exposure (OR, 1.08; 95% CI, 0.81-1.44). There was also no difference in oral versus topical exposure (OR, 1.18; 95% CI, 0.61-2.29).

iStock

With respect to spontaneous abortions, there was no significant association with oral terbinafine (hazard ratio, 1.06; 95% CI, 0.86-1.32) or topical terbinafine (HR, 1.04; 95% CI, 0.88-1.21), compared with unexposed pregnancies, or oral over topical terbinafine-exposed pregnancies (HR, 1.19; 95% CI, 0.84-1.70).

The study is limited by the fact that it was conducted in a Danish population, and the data relied on filled prescriptions for determining exposure, which did not account for adherence. Residual confounding is possible because of the retrospective nature of the study, the authors pointed out.

No source of funding was disclosed. One of the authors has received grants and personal fees from Novartis. Dr. Murase has received fees from Sanofi Genzyme, Dermira, UCB, Regeneron, Ferndale, and UpToDate.
 

SOURCES: Andersson NW et al. JAMA Dermatol. 2020 Mar 4. doi: 10.1001/jamadermatol.2020.0142; Murase JE, Abel MK. JAMA Dermatol. 2020 Mar 4. doi: 10.1001/jamadermatol.2019.5036.

Treatment with the antifungal agent terbinafine during pregnancy does not appear to increase the risk of major malformations or spontaneous abortions, according to results from a large registry study in Denmark.

digitalskillet/Thinkstock

Physicians have been reluctant to prescribe the drug during pregnancy because of the limited safety data. The drug has not been associated with any signs of fetal toxicity in animal studies, but only one study – in 54 pregnancies – has examined the issue in humans and did not identify an increased fetal risk, according to Niklas Worm Andersson, MD, of the department of clinical pharmacology, Copenhagen University Hospital at Bispebjerg and Frederiksberg, and coauthors.

The retrospective, nationwide cohort study analyzed exposure to oral and tropical terbinafine in a large pregnancy registry and found no increase in the risk of major malformations or spontaneous abortions in exposed versus unexposed pregnancies. The study was published in JAMA Dermatology.

Still, these results fell short of certainty, the authors noted. “Although our results may provide reassurance for pregnancies exposed to oral terbinafine by reporting no overall increased risk of major malformations, we cannot exclude a potential increased risk of a specific malformation,” they wrote.

“To our knowledge, this is by far the largest, most statistically rigorous study in the literature regarding this topic,” Jenny E. Murase, MD, of the department of dermatology at the University of California, San Francisco, and Mary Kathryn Abel, a medical student at UCSF, wrote in an accompanying editorial. They described the study as “a substantial contribution to the nearly absent literature regarding the use of terbinafine during pregnancy. Among the antifungal medications, it is possible that terbinafine is the safest one currently available for use in pregnancy, particularly of the oral formulations.”

However, since asymptomatic onychomycosis “is typically a cosmetic, rather than medical, concern, waiting until after pregnancy to initiate therapy is reasonable. ... It is important to acknowledge the uncertainty in this field and question the appropriateness of treating non–life-threatening diseases during pregnancy and lactation,” they wrote.

The Danish researchers drew from a registry of 1,650,649 pregnancies between 1997 and 2016, which included 891 pregnancies exposed to oral terbinafine, and 3,174 exposed to topical terbinafine. Matched outcome analyses compared the exposed pregnancies with up to 40,650 controls unexposed during pregnancy.

Propensity-matched comparisons showed no increased risk of major malformations for oral terbinafine exposure versus no exposure (odds ratio, 1.01; 95% confidence interval, 0.63-1.62) or topical exposure versus no exposure (OR, 1.08; 95% CI, 0.81-1.44). There was also no difference in oral versus topical exposure (OR, 1.18; 95% CI, 0.61-2.29).

iStock

With respect to spontaneous abortions, there was no significant association with oral terbinafine (hazard ratio, 1.06; 95% CI, 0.86-1.32) or topical terbinafine (HR, 1.04; 95% CI, 0.88-1.21), compared with unexposed pregnancies, or oral over topical terbinafine-exposed pregnancies (HR, 1.19; 95% CI, 0.84-1.70).

The study is limited by the fact that it was conducted in a Danish population, and the data relied on filled prescriptions for determining exposure, which did not account for adherence. Residual confounding is possible because of the retrospective nature of the study, the authors pointed out.

No source of funding was disclosed. One of the authors has received grants and personal fees from Novartis. Dr. Murase has received fees from Sanofi Genzyme, Dermira, UCB, Regeneron, Ferndale, and UpToDate.
 

SOURCES: Andersson NW et al. JAMA Dermatol. 2020 Mar 4. doi: 10.1001/jamadermatol.2020.0142; Murase JE, Abel MK. JAMA Dermatol. 2020 Mar 4. doi: 10.1001/jamadermatol.2019.5036.

He Y, Zhong J, Zhou W, et al. Four surgical strategies for the treatment of cesarean scar defect: a systematic review and network meta-analysis. J Minim Invasive Gynecol. 2020;27:593-602.

EXPERT COMMENTARY

With the increase in cesarean deliveries performed over the decades, the sequelae of the surgery are now arising. Cesarean scar defects (CSDs) are a complication seen when the endometrium and muscular layers from a prior uterine scar are damaged. This damage in the uterine scar can lead to abnormal uterine bleeding and the implantation of an ectopic pregnancy, which can be life-threatening. Ultrasonography can be used to diagnose this defect, which can appear as a hypoechoic space filled with postmenstrual blood, representing a myometrial tear at the wound site.¹ There are several risk factors for CSD, including multiple cesarean deliveries, cesarean delivery during advanced stages of labor, and uterine incisions near the cervix. Elevated body mass index as well as gestational diabetes also have been found to be associated with inadequate healing of the prior cesarean incision.² Studies have shown that both single- and double-layer closure of the hysterotomy during a cesarean delivery have similar incidences of CSDs.^3,4 There are multiple ways to correct a CSD; however, there is no gold standard that has been identified in the literature.

Details about the study

The study by He and colleagues is a meta-analysis aimed at comparing the treatment of CSDs via laparoscopy, hysteroscopy, combined hysteroscopy and laparoscopy, and vaginal repair. The primary outcome measures were reduction in abnormal uterine bleeding and scar defect depth. A total of 10 studies (n = 858) were reviewed: 4 randomized controlled trials (RCTs) and 6 observational studies. The studies analyzed varied in terms of which techniques were compared.

Patients who underwent uterine scar resection by combined laparoscopy and hysteroscopy had a shorter duration of abnormal uterine bleeding when compared with hysteroscopy alone (standardized mean difference [SMD] = 1.36; 95% confidence interval [CI], 0.37−2.36; P = .007) and vaginal repair (SMD = 1.58; 95% CI, 0.97−2.19; P<.0001). Combined laparoscopic and hysteroscopic technique also was found to reduce the diverticulum depth more than in vaginal repair (SMD = 1.57; 95% CI, 0.54−2.61; P = .003).

Continue to: Study strengths and weaknesses...

Study strengths and weaknesses

This is the first meta-analysis to compare the different surgical techniques to correct a CSD. The authors were able to compare many of the characteristics regarding the routes of repair, including hysteroscopy, laparoscopy, and vaginal. The authors were able to analyze the combined laparoscopic and hysteroscopic approach, which facilitates evaluation of the location and satisfaction of defect repair during the procedure.

Some weaknesses of this study include the limited amount of RCTs available for review. All studies were also from China, where the rate of CSDs is higher. Therefore, the results may not be generalizable to all populations. Given that the included studies were done at different sites, it is difficult to determine surgical expertise and surgical technique. Additionally, the studies analyzed varied by which techniques were compared; therefore, indirect analyses were conducted to compare certain techniques. There was limited follow-up for these patients (anywhere from 3 to 6 months), so long-term data and future pregnancy data are needed to determine the efficacy of these procedures.

He Y, Zhong J, Zhou W, et al. Four surgical strategies for the treatment of cesarean scar defect: a systematic review and network meta-analysis. J Minim Invasive Gynecol. 2020;27:593-602.

EXPERT COMMENTARY

With the increase in cesarean deliveries performed over the decades, the sequelae of the surgery are now arising. Cesarean scar defects (CSDs) are a complication seen when the endometrium and muscular layers from a prior uterine scar are damaged. This damage in the uterine scar can lead to abnormal uterine bleeding and the implantation of an ectopic pregnancy, which can be life-threatening. Ultrasonography can be used to diagnose this defect, which can appear as a hypoechoic space filled with postmenstrual blood, representing a myometrial tear at the wound site.¹ There are several risk factors for CSD, including multiple cesarean deliveries, cesarean delivery during advanced stages of labor, and uterine incisions near the cervix. Elevated body mass index as well as gestational diabetes also have been found to be associated with inadequate healing of the prior cesarean incision.² Studies have shown that both single- and double-layer closure of the hysterotomy during a cesarean delivery have similar incidences of CSDs.^3,4 There are multiple ways to correct a CSD; however, there is no gold standard that has been identified in the literature.

Details about the study

The study by He and colleagues is a meta-analysis aimed at comparing the treatment of CSDs via laparoscopy, hysteroscopy, combined hysteroscopy and laparoscopy, and vaginal repair. The primary outcome measures were reduction in abnormal uterine bleeding and scar defect depth. A total of 10 studies (n = 858) were reviewed: 4 randomized controlled trials (RCTs) and 6 observational studies. The studies analyzed varied in terms of which techniques were compared.

Patients who underwent uterine scar resection by combined laparoscopy and hysteroscopy had a shorter duration of abnormal uterine bleeding when compared with hysteroscopy alone (standardized mean difference [SMD] = 1.36; 95% confidence interval [CI], 0.37−2.36; P = .007) and vaginal repair (SMD = 1.58; 95% CI, 0.97−2.19; P<.0001). Combined laparoscopic and hysteroscopic technique also was found to reduce the diverticulum depth more than in vaginal repair (SMD = 1.57; 95% CI, 0.54−2.61; P = .003).

Continue to: Study strengths and weaknesses...

Study strengths and weaknesses

This is the first meta-analysis to compare the different surgical techniques to correct a CSD. The authors were able to compare many of the characteristics regarding the routes of repair, including hysteroscopy, laparoscopy, and vaginal. The authors were able to analyze the combined laparoscopic and hysteroscopic approach, which facilitates evaluation of the location and satisfaction of defect repair during the procedure.

Some weaknesses of this study include the limited amount of RCTs available for review. All studies were also from China, where the rate of CSDs is higher. Therefore, the results may not be generalizable to all populations. Given that the included studies were done at different sites, it is difficult to determine surgical expertise and surgical technique. Additionally, the studies analyzed varied by which techniques were compared; therefore, indirect analyses were conducted to compare certain techniques. There was limited follow-up for these patients (anywhere from 3 to 6 months), so long-term data and future pregnancy data are needed to determine the efficacy of these procedures.

He Y, Zhong J, Zhou W, et al. Four surgical strategies for the treatment of cesarean scar defect: a systematic review and network meta-analysis. J Minim Invasive Gynecol. 2020;27:593-602.

EXPERT COMMENTARY

With the increase in cesarean deliveries performed over the decades, the sequelae of the surgery are now arising. Cesarean scar defects (CSDs) are a complication seen when the endometrium and muscular layers from a prior uterine scar are damaged. This damage in the uterine scar can lead to abnormal uterine bleeding and the implantation of an ectopic pregnancy, which can be life-threatening. Ultrasonography can be used to diagnose this defect, which can appear as a hypoechoic space filled with postmenstrual blood, representing a myometrial tear at the wound site.¹ There are several risk factors for CSD, including multiple cesarean deliveries, cesarean delivery during advanced stages of labor, and uterine incisions near the cervix. Elevated body mass index as well as gestational diabetes also have been found to be associated with inadequate healing of the prior cesarean incision.² Studies have shown that both single- and double-layer closure of the hysterotomy during a cesarean delivery have similar incidences of CSDs.^3,4 There are multiple ways to correct a CSD; however, there is no gold standard that has been identified in the literature.

Details about the study

The study by He and colleagues is a meta-analysis aimed at comparing the treatment of CSDs via laparoscopy, hysteroscopy, combined hysteroscopy and laparoscopy, and vaginal repair. The primary outcome measures were reduction in abnormal uterine bleeding and scar defect depth. A total of 10 studies (n = 858) were reviewed: 4 randomized controlled trials (RCTs) and 6 observational studies. The studies analyzed varied in terms of which techniques were compared.

Patients who underwent uterine scar resection by combined laparoscopy and hysteroscopy had a shorter duration of abnormal uterine bleeding when compared with hysteroscopy alone (standardized mean difference [SMD] = 1.36; 95% confidence interval [CI], 0.37−2.36; P = .007) and vaginal repair (SMD = 1.58; 95% CI, 0.97−2.19; P<.0001). Combined laparoscopic and hysteroscopic technique also was found to reduce the diverticulum depth more than in vaginal repair (SMD = 1.57; 95% CI, 0.54−2.61; P = .003).

Continue to: Study strengths and weaknesses...

Study strengths and weaknesses

This is the first meta-analysis to compare the different surgical techniques to correct a CSD. The authors were able to compare many of the characteristics regarding the routes of repair, including hysteroscopy, laparoscopy, and vaginal. The authors were able to analyze the combined laparoscopic and hysteroscopic approach, which facilitates evaluation of the location and satisfaction of defect repair during the procedure.

Some weaknesses of this study include the limited amount of RCTs available for review. All studies were also from China, where the rate of CSDs is higher. Therefore, the results may not be generalizable to all populations. Given that the included studies were done at different sites, it is difficult to determine surgical expertise and surgical technique. Additionally, the studies analyzed varied by which techniques were compared; therefore, indirect analyses were conducted to compare certain techniques. There was limited follow-up for these patients (anywhere from 3 to 6 months), so long-term data and future pregnancy data are needed to determine the efficacy of these procedures.

When she was 4 months pregnant, Angela Crawley waited for 30 minutes in a private room to hear the results of her noninvasive prenatal testing. Her ultrasound had been flagged as high risk by the radiologist and she agreed to undergo further testing to gather information on the health of her unborn child.

As she waited for her genetic counseling appointment, she noticed somber expressions on the faces of her health team and picked up on hushed tones.

It had taken 2 years to become pregnant and the joy she felt attending prenatal care appointments was fading into a sense of dread as she sat in that small room and the minutes ticked by.

Crawley – a scientist in the chronic disease program at the Ottawa Hospital Research Institute, assistant professor at the University of Ottawa, and adjunct research professor at Carleton University in Ontario, Canada – is more qualified than most patients to absorb health information and make appropriate decisions.

And yet, “I was completely unprepared,” she told Medscape Medical News as she reflected on what she now refers to as some of the darkest days of her life. “It was a nightmare and it was such a confusing, scary time.”

Crawley is among the more than 6 million women from at least 90 countries who have undergone noninvasive prenatal testing. During pregnancy, a mother’s bloodstream contains a mix of cell-free DNA from her own cells and from placental cells, which is usually identical to the DNA of the fetus. Analysis of cell-free DNA can lead to the early detection of genetic disorders.

Testing is most often used to look for chromosomal disorders that are caused by the presence of an extra chromosome, like in trisomy 21 in the case of Down syndrome or extra or missing copies of the X and Y chromosomes in other disorders. The accuracy of the test tends to vary, depending on the condition being assessed.

Cell-free DNA testing has reduced the number of invasive prenatal diagnostic procedures, some of which can lead to miscarriage, and this noninvasive option made sense to Crawley and was covered by government health insurance.

With a market projected to surpass $13 billion by the year 2027, some experts speculate that prenatal genetic testing is the most rapidly adopted test in human history. Globally, noninvasive prenatal tests cost $500 to $3,000 for patients who pay out of pocket, and all those screening options are amassing valuable genetic data troves.

The pioneer of noninvasive prenatal testing, Dennis Lo, PhD, from the Chinese University of Hong Kong, told Medscape Medical News that the success of using cell-free DNA came after a long, winding road of rejected grant applications and scientific skepticism.

“Initially, people did not think this would be useful for assessing chromosomal abnormalities because the thinking at the time was that we would need to count them,” Lo said.

But he was enchanted by early glimpses of the capability of cell-free DNA, and felt driven to pursue unconventional research ideas even though there were significant hurdles to overcome in the lab.

“We were detecting fetal Y chromosomes in women. At first, it was just scientific curiosity,” said Lo. “At the time, people worried that fetal cells would persist from one pregnancy to the next, but we discovered that fetal DNA actually clears very quickly and does not progress into the next pregnancy,” he explained. “This is very important because it won’t alter the accuracy of the test.”

Gripped by the scientific mystery, the researcher put in long hours at the lab. “I’m fortunate I have a very understanding wife who is herself a scientist,” he said. After a particularly long stretch without quality time together, Lo and his spouse, Alice Wong, went to see a Harry Potter movie.

As Lo viewed the Harry Potter H through 3D glasses, he was suddenly reminded of the male human karyotype.

“I saw the vertical stripes of the H and it hit me,” he told Medscape Medical News. “There are two sets of chromosomes.” The average human karyotype contains 22 pairs of autosomal chromosomes and one pair of sex chromosomes.

“Our complex genetic conundrum was cracked in the middle of a Harry Potter movie in a moment when I felt completely relaxed,” he recalled. “My wife said: ‘You can’t even watch a movie properly.’ ”

Back at the lab, Lo shared his Harry Potter–inspired concept and the team got to work.

In December 2019, Lo received the Fudan-Zhongzhi Science Award in Shanghai from Nobel laureate physicist Samuel Chao Chung Ting, chair of the award committee. The prize honors fundamental and groundbreaking achievements in biomedicine, and the laureate receives ¥3 million (about U.S. $428,550), donated by Zhongzhi Enterprise Group.

This honor was 30 years in the making, Lo told Medscape Medical News. “I’m pleased to experience public recognition and this is a high honor in China,” he added.

“Noninvasive prenatal testing is better than anything we’ve ever had before,” said Ronald Wapner, MD, from the Columbia University Irving Medical Center in New York City, who taught a course on the transition of prenatal diagnostics from amniocentesis to whole-genome sequencing at the recent Society for Maternal–Fetal Medicine 2020 Annual Pregnancy Meeting.

“We now have the capability to improve healthcare decision-making in utero and at birth,” he told Medscape Medical News. “It’s remarkable.”

But, Wapner said, the market grew too fast. “The National Institutes of Health didn’t even play a role in these fast-paced developments. Traditional governing bodies and authorities were bypassed as cytogenetic labs marketed directly to physicians and patients,” he explained.

One of the major problems with the rapid uptake in testing is a lack of preparation for patients like Crawley.

The clinician who delivered her test results was not feeling well, so “she spoke through a surgical mask,” Crawley reported. “I was trying to understand what she was saying, but it was an uncomfortable exchange.”

Crawley had undergone prenatal genetic testing because her ultrasound had shown irregularities in fetal leg measurements. The genetic tests confirmed no anomalies in the chromosome count, but that was it.

“There was no prognosis, just vague numbers that no one seemed to know what to do with,” Crawley recalled.

With concern about growth measurements, the conversation moved quickly to options, including termination. Crawley said the dialogue felt jarring and moved too quickly for her to process all the information and possible courses of action.

She was told she could terminate and “try again to get pregnant.” But Crawley was 39 years old and had been trying to conceive for 2 years.

“It was devastating,” she said. “No one sat down with me before this appointment to learn about my values or preferences, and I left that conversation with more questions than I had before I arrived. I went home and had one the worst weekends of my life. My husband and I felt so overwhelmed, grieved, and alone.”

Pretest counseling can be as important as any subsequent genetic counseling, said Blair Stevens, a prenatal expert from the National Society of Genetic Counselors and a genetic counselor at the University of Texas Health Science Center in Houston.

“Information is valuable, but it can also be toxic, depending on what individuals intend to do with what they learn,” she explained. “We cannot unknow or unhear details, so it’s really important to work with patients in advance to make sure their preferences guide any planning.”

Uncertainty can be very unsettling, she acknowledged. “It’s important to help patients balance any ambiguity, so if there is a 20% risk, there is also an 80% chance of another, perhaps more favorable, outcome.”

Most clinicians don’t have the time to fully assess patient goals and align counseling approaches to individual needs, Stevens explained. And public interest in prenatal testing has outpaced clinical best practices as competing labs race to expand offerings and add options to screening tests to grab a piece of the global market, which is now about 130 million births per year.

“These are not scientifically sound additions and we need more evidence,” Stevens said. “There is a right way to handle this, and labs and clinicians need to collaborate on responsible methods to test and integrate expanding options.”
 

The blue and pink elephant in the room

“The reality is that most people don’t have a super high risk for chromosomal irregularities,” said Stevens. “Most people are more interested in learning the sex of their baby in early pregnancy than in any actual desire for genetic information.” Noninvasive prenatal testing can detect fetal sex as early as 9 weeks into a pregnancy, whereas ultrasound might not detect it until about 18 weeks.

“Honestly? I think the growing popularity of gender-reveal parties is what is actually driving the push for more prenatal testing,” she added. “The problem is that a couple eager to learn the sex of their baby may wind up with way more information than they expected and have trouble processing unanticipated risk.”

In February, five national medical organizations in the United States partnered with the Reproductive Genetics Technology Consortium to develop consensus recommendations and guidelines for prenatal genetic testing.

The National Society of Genetic Counselors and the Society for Maternal–Fetal Medicine are among the new members that will provide a forum through which commercial laboratories can communicate about new technologies and obtain input and guidance on emerging options.

Wapner, who is a member of the consortium, said he hopes thought leaders will be at the forefront to guide this next chapter of prenatal screening. “So much money is pouring into all this testing; let’s make sure we are making the right, most essential screening decisions,” he said.

“Science typically advances more rapidly than the ethical and legal framework to support decision-making, and it’s important for society to put protections in place,” Lo acknowledged.

The misuse of screening and unethical sex-selection efforts in Asia and elsewhere in the world, where males are highly valued and females are more likely to be aborted, is dismaying, he told Medscape Medical News. “These are exploitations of the science.”

In addition to scientific misuse like sex selection, data breaches are becoming a huge concern as companies amass large amounts of valuable genetic information.
 

Data for ransom

In Canada, where Crawley took her test, LifeLabs – the country’s largest laboratory testing company and a provider of genetic testing – paid a ransom after a major cyberattack led to the theft of lab results for 85,000 people in Ontario and the personal information of 15 million customers.

LifeLabs paid an undisclosed sum to retrieve the data, the company reported on December 17, and hired cybersecurity experts to assess the damage. The company is offering security protection services, including identity theft and fraud protection insurance, to customers.

“This has served as a reminder that we need to stay ahead of cybercrime, which has become a pervasive issue around the world in all sectors,” Charles Brown, president and chief executive officer of LifeLabs, wrote in a letter to customers. “You entrust us with important health information, and we take that responsibility very seriously.”

The United States has led the world in the commercial push for more prenatal testing. Other countries in Europe, for example, have proceeded with caution and have integrated the technologies with more controls. Hong Kong, where the inventor of the test is based, has been among the slowest to adopt the practice.

“I have been lobbying for 8 years for Hong Kong to offer testing,” said Lo. “I think Hong Kong has been too slow to integrate, but the United States probably moved too quickly. There is a balance that I think countries like the Netherlands have found; they take the aim of screening into account, along with justice and societal aspects.”

“Ideally, we will develop a great pretest model triage tool to help guide patients through this process,” Stevens said. “And we have to make sure the data they receive are clinically useful and backed up by evidence to safeguard the care of every patient.”

The practice of medicine is meticulously designed to assess and mitigate risk, “but this sensible objective can also be extremely negative in focus, with not-so-great delivery of information,” she acknowledged. Each individual’s tolerance for uncertainty and ability to cope in the face of adversity varies. “These are complex conversations that require time and empathy, and the details matter,” she added.

“In my home state of Texas, where there is a large religious base, there is not as much drive for advance prenatal genetic information,” Stevens explained. “We see a real advocacy movement emerging and a need for information from patients first because these can’t really be clinician-led decisions,” she pointed out. “Patients come to us undergoing not just the physical changes of pregnancy, but also emotional transformation as they transition to become parents. They may be nauseous or already sleep-deprived and they need our help,” she added.

Crawley could feel the fluttering of fetal movements in her womb and said she felt connected to her child, but she remembered her trip to Ireland when she and her husband drank too much and they likely conceived. Irrational thoughts crept in: “Maybe it was something we did. What about my swimming; could it have been harmful?”

Apprehensions lingered as she waited to meet her specialist. Would the child grow and be able to walk? Be held back by disabling joint pain? Crawley sat down with her doctor at the high-risk clinic to discuss the possibilities.

“I don’t see anything to be alarmed about. She’s probably going to be small,” said the obstetrician.

“She?!” Crawley had opted not to learn the sex of her baby, unlike so many other parents she knew, but her hope for her baby’s good health soared above the accidental disclosure.

“Everything changed in that moment,” Crawley said. “I knew that we were going to be okay no matter what happened next.”

Crawley’s pregnancy progressed to term and she gave birth to a healthy baby girl who is now 3 years old and dances ballet. Her beloved daughter is shorter than some of the other dancers in her class, but her mom says she hasn’t missed a beat. “The world is a better place because my daughter is in it,” Crawley said. “This, I know for sure.”

This article first appeared on Medscape.com.

When she was 4 months pregnant, Angela Crawley waited for 30 minutes in a private room to hear the results of her noninvasive prenatal testing. Her ultrasound had been flagged as high risk by the radiologist and she agreed to undergo further testing to gather information on the health of her unborn child.

As she waited for her genetic counseling appointment, she noticed somber expressions on the faces of her health team and picked up on hushed tones.

It had taken 2 years to become pregnant and the joy she felt attending prenatal care appointments was fading into a sense of dread as she sat in that small room and the minutes ticked by.

Crawley – a scientist in the chronic disease program at the Ottawa Hospital Research Institute, assistant professor at the University of Ottawa, and adjunct research professor at Carleton University in Ontario, Canada – is more qualified than most patients to absorb health information and make appropriate decisions.

And yet, “I was completely unprepared,” she told Medscape Medical News as she reflected on what she now refers to as some of the darkest days of her life. “It was a nightmare and it was such a confusing, scary time.”

Crawley is among the more than 6 million women from at least 90 countries who have undergone noninvasive prenatal testing. During pregnancy, a mother’s bloodstream contains a mix of cell-free DNA from her own cells and from placental cells, which is usually identical to the DNA of the fetus. Analysis of cell-free DNA can lead to the early detection of genetic disorders.

Testing is most often used to look for chromosomal disorders that are caused by the presence of an extra chromosome, like in trisomy 21 in the case of Down syndrome or extra or missing copies of the X and Y chromosomes in other disorders. The accuracy of the test tends to vary, depending on the condition being assessed.

Cell-free DNA testing has reduced the number of invasive prenatal diagnostic procedures, some of which can lead to miscarriage, and this noninvasive option made sense to Crawley and was covered by government health insurance.

With a market projected to surpass $13 billion by the year 2027, some experts speculate that prenatal genetic testing is the most rapidly adopted test in human history. Globally, noninvasive prenatal tests cost $500 to $3,000 for patients who pay out of pocket, and all those screening options are amassing valuable genetic data troves.

The pioneer of noninvasive prenatal testing, Dennis Lo, PhD, from the Chinese University of Hong Kong, told Medscape Medical News that the success of using cell-free DNA came after a long, winding road of rejected grant applications and scientific skepticism.

“Initially, people did not think this would be useful for assessing chromosomal abnormalities because the thinking at the time was that we would need to count them,” Lo said.

But he was enchanted by early glimpses of the capability of cell-free DNA, and felt driven to pursue unconventional research ideas even though there were significant hurdles to overcome in the lab.

“We were detecting fetal Y chromosomes in women. At first, it was just scientific curiosity,” said Lo. “At the time, people worried that fetal cells would persist from one pregnancy to the next, but we discovered that fetal DNA actually clears very quickly and does not progress into the next pregnancy,” he explained. “This is very important because it won’t alter the accuracy of the test.”

Gripped by the scientific mystery, the researcher put in long hours at the lab. “I’m fortunate I have a very understanding wife who is herself a scientist,” he said. After a particularly long stretch without quality time together, Lo and his spouse, Alice Wong, went to see a Harry Potter movie.

As Lo viewed the Harry Potter H through 3D glasses, he was suddenly reminded of the male human karyotype.

“I saw the vertical stripes of the H and it hit me,” he told Medscape Medical News. “There are two sets of chromosomes.” The average human karyotype contains 22 pairs of autosomal chromosomes and one pair of sex chromosomes.

“Our complex genetic conundrum was cracked in the middle of a Harry Potter movie in a moment when I felt completely relaxed,” he recalled. “My wife said: ‘You can’t even watch a movie properly.’ ”

Back at the lab, Lo shared his Harry Potter–inspired concept and the team got to work.

In December 2019, Lo received the Fudan-Zhongzhi Science Award in Shanghai from Nobel laureate physicist Samuel Chao Chung Ting, chair of the award committee. The prize honors fundamental and groundbreaking achievements in biomedicine, and the laureate receives ¥3 million (about U.S. $428,550), donated by Zhongzhi Enterprise Group.

This honor was 30 years in the making, Lo told Medscape Medical News. “I’m pleased to experience public recognition and this is a high honor in China,” he added.

“Noninvasive prenatal testing is better than anything we’ve ever had before,” said Ronald Wapner, MD, from the Columbia University Irving Medical Center in New York City, who taught a course on the transition of prenatal diagnostics from amniocentesis to whole-genome sequencing at the recent Society for Maternal–Fetal Medicine 2020 Annual Pregnancy Meeting.

“We now have the capability to improve healthcare decision-making in utero and at birth,” he told Medscape Medical News. “It’s remarkable.”

But, Wapner said, the market grew too fast. “The National Institutes of Health didn’t even play a role in these fast-paced developments. Traditional governing bodies and authorities were bypassed as cytogenetic labs marketed directly to physicians and patients,” he explained.

One of the major problems with the rapid uptake in testing is a lack of preparation for patients like Crawley.

The clinician who delivered her test results was not feeling well, so “she spoke through a surgical mask,” Crawley reported. “I was trying to understand what she was saying, but it was an uncomfortable exchange.”

Crawley had undergone prenatal genetic testing because her ultrasound had shown irregularities in fetal leg measurements. The genetic tests confirmed no anomalies in the chromosome count, but that was it.

“There was no prognosis, just vague numbers that no one seemed to know what to do with,” Crawley recalled.

With concern about growth measurements, the conversation moved quickly to options, including termination. Crawley said the dialogue felt jarring and moved too quickly for her to process all the information and possible courses of action.

She was told she could terminate and “try again to get pregnant.” But Crawley was 39 years old and had been trying to conceive for 2 years.

“It was devastating,” she said. “No one sat down with me before this appointment to learn about my values or preferences, and I left that conversation with more questions than I had before I arrived. I went home and had one the worst weekends of my life. My husband and I felt so overwhelmed, grieved, and alone.”

Pretest counseling can be as important as any subsequent genetic counseling, said Blair Stevens, a prenatal expert from the National Society of Genetic Counselors and a genetic counselor at the University of Texas Health Science Center in Houston.

“Information is valuable, but it can also be toxic, depending on what individuals intend to do with what they learn,” she explained. “We cannot unknow or unhear details, so it’s really important to work with patients in advance to make sure their preferences guide any planning.”

Uncertainty can be very unsettling, she acknowledged. “It’s important to help patients balance any ambiguity, so if there is a 20% risk, there is also an 80% chance of another, perhaps more favorable, outcome.”

Most clinicians don’t have the time to fully assess patient goals and align counseling approaches to individual needs, Stevens explained. And public interest in prenatal testing has outpaced clinical best practices as competing labs race to expand offerings and add options to screening tests to grab a piece of the global market, which is now about 130 million births per year.

“These are not scientifically sound additions and we need more evidence,” Stevens said. “There is a right way to handle this, and labs and clinicians need to collaborate on responsible methods to test and integrate expanding options.”
 

The blue and pink elephant in the room

“The reality is that most people don’t have a super high risk for chromosomal irregularities,” said Stevens. “Most people are more interested in learning the sex of their baby in early pregnancy than in any actual desire for genetic information.” Noninvasive prenatal testing can detect fetal sex as early as 9 weeks into a pregnancy, whereas ultrasound might not detect it until about 18 weeks.

“Honestly? I think the growing popularity of gender-reveal parties is what is actually driving the push for more prenatal testing,” she added. “The problem is that a couple eager to learn the sex of their baby may wind up with way more information than they expected and have trouble processing unanticipated risk.”

In February, five national medical organizations in the United States partnered with the Reproductive Genetics Technology Consortium to develop consensus recommendations and guidelines for prenatal genetic testing.

The National Society of Genetic Counselors and the Society for Maternal–Fetal Medicine are among the new members that will provide a forum through which commercial laboratories can communicate about new technologies and obtain input and guidance on emerging options.

Wapner, who is a member of the consortium, said he hopes thought leaders will be at the forefront to guide this next chapter of prenatal screening. “So much money is pouring into all this testing; let’s make sure we are making the right, most essential screening decisions,” he said.

“Science typically advances more rapidly than the ethical and legal framework to support decision-making, and it’s important for society to put protections in place,” Lo acknowledged.

The misuse of screening and unethical sex-selection efforts in Asia and elsewhere in the world, where males are highly valued and females are more likely to be aborted, is dismaying, he told Medscape Medical News. “These are exploitations of the science.”

In addition to scientific misuse like sex selection, data breaches are becoming a huge concern as companies amass large amounts of valuable genetic information.
 

Data for ransom

In Canada, where Crawley took her test, LifeLabs – the country’s largest laboratory testing company and a provider of genetic testing – paid a ransom after a major cyberattack led to the theft of lab results for 85,000 people in Ontario and the personal information of 15 million customers.

LifeLabs paid an undisclosed sum to retrieve the data, the company reported on December 17, and hired cybersecurity experts to assess the damage. The company is offering security protection services, including identity theft and fraud protection insurance, to customers.

“This has served as a reminder that we need to stay ahead of cybercrime, which has become a pervasive issue around the world in all sectors,” Charles Brown, president and chief executive officer of LifeLabs, wrote in a letter to customers. “You entrust us with important health information, and we take that responsibility very seriously.”

The United States has led the world in the commercial push for more prenatal testing. Other countries in Europe, for example, have proceeded with caution and have integrated the technologies with more controls. Hong Kong, where the inventor of the test is based, has been among the slowest to adopt the practice.

“I have been lobbying for 8 years for Hong Kong to offer testing,” said Lo. “I think Hong Kong has been too slow to integrate, but the United States probably moved too quickly. There is a balance that I think countries like the Netherlands have found; they take the aim of screening into account, along with justice and societal aspects.”

“Ideally, we will develop a great pretest model triage tool to help guide patients through this process,” Stevens said. “And we have to make sure the data they receive are clinically useful and backed up by evidence to safeguard the care of every patient.”

The practice of medicine is meticulously designed to assess and mitigate risk, “but this sensible objective can also be extremely negative in focus, with not-so-great delivery of information,” she acknowledged. Each individual’s tolerance for uncertainty and ability to cope in the face of adversity varies. “These are complex conversations that require time and empathy, and the details matter,” she added.

“In my home state of Texas, where there is a large religious base, there is not as much drive for advance prenatal genetic information,” Stevens explained. “We see a real advocacy movement emerging and a need for information from patients first because these can’t really be clinician-led decisions,” she pointed out. “Patients come to us undergoing not just the physical changes of pregnancy, but also emotional transformation as they transition to become parents. They may be nauseous or already sleep-deprived and they need our help,” she added.

Crawley could feel the fluttering of fetal movements in her womb and said she felt connected to her child, but she remembered her trip to Ireland when she and her husband drank too much and they likely conceived. Irrational thoughts crept in: “Maybe it was something we did. What about my swimming; could it have been harmful?”

Apprehensions lingered as she waited to meet her specialist. Would the child grow and be able to walk? Be held back by disabling joint pain? Crawley sat down with her doctor at the high-risk clinic to discuss the possibilities.

“I don’t see anything to be alarmed about. She’s probably going to be small,” said the obstetrician.

“She?!” Crawley had opted not to learn the sex of her baby, unlike so many other parents she knew, but her hope for her baby’s good health soared above the accidental disclosure.

“Everything changed in that moment,” Crawley said. “I knew that we were going to be okay no matter what happened next.”

Crawley’s pregnancy progressed to term and she gave birth to a healthy baby girl who is now 3 years old and dances ballet. Her beloved daughter is shorter than some of the other dancers in her class, but her mom says she hasn’t missed a beat. “The world is a better place because my daughter is in it,” Crawley said. “This, I know for sure.”

This article first appeared on Medscape.com.

When she was 4 months pregnant, Angela Crawley waited for 30 minutes in a private room to hear the results of her noninvasive prenatal testing. Her ultrasound had been flagged as high risk by the radiologist and she agreed to undergo further testing to gather information on the health of her unborn child.

As she waited for her genetic counseling appointment, she noticed somber expressions on the faces of her health team and picked up on hushed tones.

It had taken 2 years to become pregnant and the joy she felt attending prenatal care appointments was fading into a sense of dread as she sat in that small room and the minutes ticked by.

Crawley – a scientist in the chronic disease program at the Ottawa Hospital Research Institute, assistant professor at the University of Ottawa, and adjunct research professor at Carleton University in Ontario, Canada – is more qualified than most patients to absorb health information and make appropriate decisions.

And yet, “I was completely unprepared,” she told Medscape Medical News as she reflected on what she now refers to as some of the darkest days of her life. “It was a nightmare and it was such a confusing, scary time.”

Crawley is among the more than 6 million women from at least 90 countries who have undergone noninvasive prenatal testing. During pregnancy, a mother’s bloodstream contains a mix of cell-free DNA from her own cells and from placental cells, which is usually identical to the DNA of the fetus. Analysis of cell-free DNA can lead to the early detection of genetic disorders.

Testing is most often used to look for chromosomal disorders that are caused by the presence of an extra chromosome, like in trisomy 21 in the case of Down syndrome or extra or missing copies of the X and Y chromosomes in other disorders. The accuracy of the test tends to vary, depending on the condition being assessed.

Cell-free DNA testing has reduced the number of invasive prenatal diagnostic procedures, some of which can lead to miscarriage, and this noninvasive option made sense to Crawley and was covered by government health insurance.

With a market projected to surpass $13 billion by the year 2027, some experts speculate that prenatal genetic testing is the most rapidly adopted test in human history. Globally, noninvasive prenatal tests cost $500 to $3,000 for patients who pay out of pocket, and all those screening options are amassing valuable genetic data troves.

The pioneer of noninvasive prenatal testing, Dennis Lo, PhD, from the Chinese University of Hong Kong, told Medscape Medical News that the success of using cell-free DNA came after a long, winding road of rejected grant applications and scientific skepticism.

“Initially, people did not think this would be useful for assessing chromosomal abnormalities because the thinking at the time was that we would need to count them,” Lo said.

But he was enchanted by early glimpses of the capability of cell-free DNA, and felt driven to pursue unconventional research ideas even though there were significant hurdles to overcome in the lab.

“We were detecting fetal Y chromosomes in women. At first, it was just scientific curiosity,” said Lo. “At the time, people worried that fetal cells would persist from one pregnancy to the next, but we discovered that fetal DNA actually clears very quickly and does not progress into the next pregnancy,” he explained. “This is very important because it won’t alter the accuracy of the test.”

Gripped by the scientific mystery, the researcher put in long hours at the lab. “I’m fortunate I have a very understanding wife who is herself a scientist,” he said. After a particularly long stretch without quality time together, Lo and his spouse, Alice Wong, went to see a Harry Potter movie.

As Lo viewed the Harry Potter H through 3D glasses, he was suddenly reminded of the male human karyotype.

“I saw the vertical stripes of the H and it hit me,” he told Medscape Medical News. “There are two sets of chromosomes.” The average human karyotype contains 22 pairs of autosomal chromosomes and one pair of sex chromosomes.

“Our complex genetic conundrum was cracked in the middle of a Harry Potter movie in a moment when I felt completely relaxed,” he recalled. “My wife said: ‘You can’t even watch a movie properly.’ ”

Back at the lab, Lo shared his Harry Potter–inspired concept and the team got to work.

In December 2019, Lo received the Fudan-Zhongzhi Science Award in Shanghai from Nobel laureate physicist Samuel Chao Chung Ting, chair of the award committee. The prize honors fundamental and groundbreaking achievements in biomedicine, and the laureate receives ¥3 million (about U.S. $428,550), donated by Zhongzhi Enterprise Group.

This honor was 30 years in the making, Lo told Medscape Medical News. “I’m pleased to experience public recognition and this is a high honor in China,” he added.

“Noninvasive prenatal testing is better than anything we’ve ever had before,” said Ronald Wapner, MD, from the Columbia University Irving Medical Center in New York City, who taught a course on the transition of prenatal diagnostics from amniocentesis to whole-genome sequencing at the recent Society for Maternal–Fetal Medicine 2020 Annual Pregnancy Meeting.

“We now have the capability to improve healthcare decision-making in utero and at birth,” he told Medscape Medical News. “It’s remarkable.”

But, Wapner said, the market grew too fast. “The National Institutes of Health didn’t even play a role in these fast-paced developments. Traditional governing bodies and authorities were bypassed as cytogenetic labs marketed directly to physicians and patients,” he explained.

One of the major problems with the rapid uptake in testing is a lack of preparation for patients like Crawley.

The clinician who delivered her test results was not feeling well, so “she spoke through a surgical mask,” Crawley reported. “I was trying to understand what she was saying, but it was an uncomfortable exchange.”

Crawley had undergone prenatal genetic testing because her ultrasound had shown irregularities in fetal leg measurements. The genetic tests confirmed no anomalies in the chromosome count, but that was it.

“There was no prognosis, just vague numbers that no one seemed to know what to do with,” Crawley recalled.

With concern about growth measurements, the conversation moved quickly to options, including termination. Crawley said the dialogue felt jarring and moved too quickly for her to process all the information and possible courses of action.

She was told she could terminate and “try again to get pregnant.” But Crawley was 39 years old and had been trying to conceive for 2 years.

“It was devastating,” she said. “No one sat down with me before this appointment to learn about my values or preferences, and I left that conversation with more questions than I had before I arrived. I went home and had one the worst weekends of my life. My husband and I felt so overwhelmed, grieved, and alone.”

Pretest counseling can be as important as any subsequent genetic counseling, said Blair Stevens, a prenatal expert from the National Society of Genetic Counselors and a genetic counselor at the University of Texas Health Science Center in Houston.

“Information is valuable, but it can also be toxic, depending on what individuals intend to do with what they learn,” she explained. “We cannot unknow or unhear details, so it’s really important to work with patients in advance to make sure their preferences guide any planning.”

Uncertainty can be very unsettling, she acknowledged. “It’s important to help patients balance any ambiguity, so if there is a 20% risk, there is also an 80% chance of another, perhaps more favorable, outcome.”

Most clinicians don’t have the time to fully assess patient goals and align counseling approaches to individual needs, Stevens explained. And public interest in prenatal testing has outpaced clinical best practices as competing labs race to expand offerings and add options to screening tests to grab a piece of the global market, which is now about 130 million births per year.

“These are not scientifically sound additions and we need more evidence,” Stevens said. “There is a right way to handle this, and labs and clinicians need to collaborate on responsible methods to test and integrate expanding options.”
 

The blue and pink elephant in the room

“The reality is that most people don’t have a super high risk for chromosomal irregularities,” said Stevens. “Most people are more interested in learning the sex of their baby in early pregnancy than in any actual desire for genetic information.” Noninvasive prenatal testing can detect fetal sex as early as 9 weeks into a pregnancy, whereas ultrasound might not detect it until about 18 weeks.

“Honestly? I think the growing popularity of gender-reveal parties is what is actually driving the push for more prenatal testing,” she added. “The problem is that a couple eager to learn the sex of their baby may wind up with way more information than they expected and have trouble processing unanticipated risk.”

In February, five national medical organizations in the United States partnered with the Reproductive Genetics Technology Consortium to develop consensus recommendations and guidelines for prenatal genetic testing.

The National Society of Genetic Counselors and the Society for Maternal–Fetal Medicine are among the new members that will provide a forum through which commercial laboratories can communicate about new technologies and obtain input and guidance on emerging options.

Wapner, who is a member of the consortium, said he hopes thought leaders will be at the forefront to guide this next chapter of prenatal screening. “So much money is pouring into all this testing; let’s make sure we are making the right, most essential screening decisions,” he said.

“Science typically advances more rapidly than the ethical and legal framework to support decision-making, and it’s important for society to put protections in place,” Lo acknowledged.

The misuse of screening and unethical sex-selection efforts in Asia and elsewhere in the world, where males are highly valued and females are more likely to be aborted, is dismaying, he told Medscape Medical News. “These are exploitations of the science.”

In addition to scientific misuse like sex selection, data breaches are becoming a huge concern as companies amass large amounts of valuable genetic information.
 

Data for ransom

In Canada, where Crawley took her test, LifeLabs – the country’s largest laboratory testing company and a provider of genetic testing – paid a ransom after a major cyberattack led to the theft of lab results for 85,000 people in Ontario and the personal information of 15 million customers.

LifeLabs paid an undisclosed sum to retrieve the data, the company reported on December 17, and hired cybersecurity experts to assess the damage. The company is offering security protection services, including identity theft and fraud protection insurance, to customers.

“This has served as a reminder that we need to stay ahead of cybercrime, which has become a pervasive issue around the world in all sectors,” Charles Brown, president and chief executive officer of LifeLabs, wrote in a letter to customers. “You entrust us with important health information, and we take that responsibility very seriously.”

The United States has led the world in the commercial push for more prenatal testing. Other countries in Europe, for example, have proceeded with caution and have integrated the technologies with more controls. Hong Kong, where the inventor of the test is based, has been among the slowest to adopt the practice.

“I have been lobbying for 8 years for Hong Kong to offer testing,” said Lo. “I think Hong Kong has been too slow to integrate, but the United States probably moved too quickly. There is a balance that I think countries like the Netherlands have found; they take the aim of screening into account, along with justice and societal aspects.”

“Ideally, we will develop a great pretest model triage tool to help guide patients through this process,” Stevens said. “And we have to make sure the data they receive are clinically useful and backed up by evidence to safeguard the care of every patient.”

The practice of medicine is meticulously designed to assess and mitigate risk, “but this sensible objective can also be extremely negative in focus, with not-so-great delivery of information,” she acknowledged. Each individual’s tolerance for uncertainty and ability to cope in the face of adversity varies. “These are complex conversations that require time and empathy, and the details matter,” she added.

“In my home state of Texas, where there is a large religious base, there is not as much drive for advance prenatal genetic information,” Stevens explained. “We see a real advocacy movement emerging and a need for information from patients first because these can’t really be clinician-led decisions,” she pointed out. “Patients come to us undergoing not just the physical changes of pregnancy, but also emotional transformation as they transition to become parents. They may be nauseous or already sleep-deprived and they need our help,” she added.

Crawley could feel the fluttering of fetal movements in her womb and said she felt connected to her child, but she remembered her trip to Ireland when she and her husband drank too much and they likely conceived. Irrational thoughts crept in: “Maybe it was something we did. What about my swimming; could it have been harmful?”

Apprehensions lingered as she waited to meet her specialist. Would the child grow and be able to walk? Be held back by disabling joint pain? Crawley sat down with her doctor at the high-risk clinic to discuss the possibilities.

“I don’t see anything to be alarmed about. She’s probably going to be small,” said the obstetrician.

“She?!” Crawley had opted not to learn the sex of her baby, unlike so many other parents she knew, but her hope for her baby’s good health soared above the accidental disclosure.

“Everything changed in that moment,” Crawley said. “I knew that we were going to be okay no matter what happened next.”

Crawley’s pregnancy progressed to term and she gave birth to a healthy baby girl who is now 3 years old and dances ballet. Her beloved daughter is shorter than some of the other dancers in her class, but her mom says she hasn’t missed a beat. “The world is a better place because my daughter is in it,” Crawley said. “This, I know for sure.”

This article first appeared on Medscape.com.

Women who had experienced stillbirth were more than twice as likely to eventually develop end-stage renal disease (ESRD) than were those who had not, and they were also at greater risk for chronic kidney disease (CKD), according to findings published in the American Journal of Obstetrics & Gynecology.

Peter M Barrett, MB, of the University College Cork (Ireland), and colleagues conducted a population-based cohort study using data from the Swedish Medical Birth Register, National Patient Register, and the Swedish Renal Register to identify women who had live births and stillbirths. They then used anonymized unique personal identification numbers to cross-reference the registries.

From a full cohort of nearly 2 million women who gave birth during 1973-2012, and during a median follow-up of 20.7 years, 13,032 women experienced stillbirth, which, until 2008, was defined as fetal death after 28 weeks’ gestation, and after 2008, as occurring after 22 weeks. Women were excluded if they had any diagnosis of renal disease before their first pregnancy, as well as for a history of cardiovascular disease, chronic hypertension, diabetes, and certain other conditions at baseline.

Overall, 18,017 women developed CKD, and 1,283 developed ESRD. The fully adjusted model showed adjusted hazard ratios of 1.26 for CKD (95% confidence interval, 1.09-1.45) and 2.25 for ESRD (95% CI, 1.55-3.25) in women who had experienced stillbirth, compared with those who had not experienced stillbirth.

The researchers reported that associations between stillbirth and renal disease existed independently of underlying medical and obstetric comorbidities, such as congenital malformations, being small for gestational age, and preeclampsia, and that when those comorbidities were excluded, “the associations between stillbirth and maternal renal disease were strengthened (CKD: aHR, 1.33; 95% CI, 1.13-1.57; and ESRD: aHR, 2.95; 95% CI, 1.86-4.68).”

In addition, they noted that there was no significant association between stillbirth and either CKD or ESRD in women who had prepregnancy medical comorbidities (CKD: aHR, 1.13; 95% CI 0.73-1.75; and ESRD: aHR 1.49; 95% CI, 0.78-2.85).

“Further research is required to better understand the underlying pathophysiology of this association and to determine whether affected women would benefit from closer surveillance and follow-up for future hypertension and renal disease,” the authors concluded.

The work was performed within the Irish Clinical Academic Training Programme and was funded by grants from several organizations. The authors reported no conflicts of interest.

[email protected]

SOURCE: Barret PM et al. Am J Obstet Gynecol. 2020 Feb 26. doi: 10.1016/j.ajog.2020.02.031.

Women who had experienced stillbirth were more than twice as likely to eventually develop end-stage renal disease (ESRD) than were those who had not, and they were also at greater risk for chronic kidney disease (CKD), according to findings published in the American Journal of Obstetrics & Gynecology.

Peter M Barrett, MB, of the University College Cork (Ireland), and colleagues conducted a population-based cohort study using data from the Swedish Medical Birth Register, National Patient Register, and the Swedish Renal Register to identify women who had live births and stillbirths. They then used anonymized unique personal identification numbers to cross-reference the registries.

From a full cohort of nearly 2 million women who gave birth during 1973-2012, and during a median follow-up of 20.7 years, 13,032 women experienced stillbirth, which, until 2008, was defined as fetal death after 28 weeks’ gestation, and after 2008, as occurring after 22 weeks. Women were excluded if they had any diagnosis of renal disease before their first pregnancy, as well as for a history of cardiovascular disease, chronic hypertension, diabetes, and certain other conditions at baseline.

Overall, 18,017 women developed CKD, and 1,283 developed ESRD. The fully adjusted model showed adjusted hazard ratios of 1.26 for CKD (95% confidence interval, 1.09-1.45) and 2.25 for ESRD (95% CI, 1.55-3.25) in women who had experienced stillbirth, compared with those who had not experienced stillbirth.

The researchers reported that associations between stillbirth and renal disease existed independently of underlying medical and obstetric comorbidities, such as congenital malformations, being small for gestational age, and preeclampsia, and that when those comorbidities were excluded, “the associations between stillbirth and maternal renal disease were strengthened (CKD: aHR, 1.33; 95% CI, 1.13-1.57; and ESRD: aHR, 2.95; 95% CI, 1.86-4.68).”

In addition, they noted that there was no significant association between stillbirth and either CKD or ESRD in women who had prepregnancy medical comorbidities (CKD: aHR, 1.13; 95% CI 0.73-1.75; and ESRD: aHR 1.49; 95% CI, 0.78-2.85).

“Further research is required to better understand the underlying pathophysiology of this association and to determine whether affected women would benefit from closer surveillance and follow-up for future hypertension and renal disease,” the authors concluded.

The work was performed within the Irish Clinical Academic Training Programme and was funded by grants from several organizations. The authors reported no conflicts of interest.

[email protected]

SOURCE: Barret PM et al. Am J Obstet Gynecol. 2020 Feb 26. doi: 10.1016/j.ajog.2020.02.031.

Women who had experienced stillbirth were more than twice as likely to eventually develop end-stage renal disease (ESRD) than were those who had not, and they were also at greater risk for chronic kidney disease (CKD), according to findings published in the American Journal of Obstetrics & Gynecology.

Peter M Barrett, MB, of the University College Cork (Ireland), and colleagues conducted a population-based cohort study using data from the Swedish Medical Birth Register, National Patient Register, and the Swedish Renal Register to identify women who had live births and stillbirths. They then used anonymized unique personal identification numbers to cross-reference the registries.

From a full cohort of nearly 2 million women who gave birth during 1973-2012, and during a median follow-up of 20.7 years, 13,032 women experienced stillbirth, which, until 2008, was defined as fetal death after 28 weeks’ gestation, and after 2008, as occurring after 22 weeks. Women were excluded if they had any diagnosis of renal disease before their first pregnancy, as well as for a history of cardiovascular disease, chronic hypertension, diabetes, and certain other conditions at baseline.

Overall, 18,017 women developed CKD, and 1,283 developed ESRD. The fully adjusted model showed adjusted hazard ratios of 1.26 for CKD (95% confidence interval, 1.09-1.45) and 2.25 for ESRD (95% CI, 1.55-3.25) in women who had experienced stillbirth, compared with those who had not experienced stillbirth.

The researchers reported that associations between stillbirth and renal disease existed independently of underlying medical and obstetric comorbidities, such as congenital malformations, being small for gestational age, and preeclampsia, and that when those comorbidities were excluded, “the associations between stillbirth and maternal renal disease were strengthened (CKD: aHR, 1.33; 95% CI, 1.13-1.57; and ESRD: aHR, 2.95; 95% CI, 1.86-4.68).”

In addition, they noted that there was no significant association between stillbirth and either CKD or ESRD in women who had prepregnancy medical comorbidities (CKD: aHR, 1.13; 95% CI 0.73-1.75; and ESRD: aHR 1.49; 95% CI, 0.78-2.85).

“Further research is required to better understand the underlying pathophysiology of this association and to determine whether affected women would benefit from closer surveillance and follow-up for future hypertension and renal disease,” the authors concluded.

The work was performed within the Irish Clinical Academic Training Programme and was funded by grants from several organizations. The authors reported no conflicts of interest.

[email protected]

SOURCE: Barret PM et al. Am J Obstet Gynecol. 2020 Feb 26. doi: 10.1016/j.ajog.2020.02.031.

Most J, St Amant M, Hsia DS, et al. Evidence-based recommendations for energy intake in pregnant women with obesity. J Clin Invest. 2019;129:4682-4690.

EXPERT COMMENTARY

In 2009, the Institute of Medicine, now known as the National Academy of Medicine, updated its gestational weight gain guideline. This guideline’s major difference, compared with the 1990 guideline, is a specific weight gain range for women with obesity: 5 to 9 kg, or 11 to 20 lb.¹ This weight gain range was chosen in part because it allows for a minimum weight gain that supports the growth and development of tissues (fetus, placenta, breast, uterus) and fluids (blood volume, intracellular and extracellular fluid), also known as the “fat-free” mass.

Many studies have since shown not only associations between lower-than-guideline-recommended weight gain and improved pregnancy outcomes (for example, reductions in preeclampsia and cesarean deliveries), but also increases in low birth weight for infants of women with obesity.^2,3 Although the weight gain guideline differs based on a woman’s prepregnancy body mass index, the energy requirements, or how many additional calories a woman should consume daily, are the same for all, regardless of weight prior to pregnancy: an increase by 340 to 452 kcal/day in the second and third trimesters.¹

Recently, Most and colleagues challenged this recommendation for energy requirements with results from their prospective observational study of 54 women with obesity during pregnancy.⁴ They aimed to evaluate energy intake with the energy intake-balance method (doubly labeled water and whole-room indirect calorimetry and body composition) according to tests done at 13 to 16 weeks’ gestation and 35 to 37 weeks’ gestation and according to the current National Academy of Medicine gestational weight gain guideline (inadequate, recommended, or excessive weight gain groups).⁴

Details of the study

Women who participated in this study were recruited from the Pennington Biomedical Research Center in Louisiana and were mostly multiparas (57%); about half had a college degree or higher (52%) and 41% were African American. The investigators found that gestational weight gain in their participants was similar to that found in other large epidemiologic studies in that 67% of women had excessive gestational weight gain.⁵

Findings. For women who gained the recommended amount of weight (n = 8), mean (SD) daily energy intake was 2,698 (99) kcal/day and energy expenditure was 2,824 (105) kcal/day. Therefore, to meet the recommended amount of weight gain, these women had a negative energy balance (-125 [52] kcal/day). Women with inadequate weight gain
(n = 10) also had a negative energy balance (-262 [32] kcal/day), but the difference was not significantly different compared with that in the recommended gestational weight gain group (P = .08). By contrast, women with excessive gestational weight gain (n = 36) had a mean (SD) positive energy balance of 186 (29) kcal/day.

Fat-free mass and fat mass weight gains. The body weight gains of the fat-free and fat mass compartments also were compared with linear mixed effect models among the 3 weight gain groups. There were no differences in the amount of fat-free mass gained among the 3 weight gain groups (P>.05), but women with excessive gestational weight gain had significantly higher increases in fat mass compared with the other 2 weight gain groups (P<.001).

Pregnancy outcomes. Although there were no differences in cesarean deliveries or birth weight among the 3 weight gain groups, the study was not powered to detect these differences.

Continue to: Study strengths and limitations...

Study strengths and limitations

It is important to note that this study by Most and colleagues was not a health behavior intervention for gestational weight gain. Women who participated in the study did not receive specific directions or advice on diet or physical activity. Furthermore, the study used the current gestational weight gain guideline as a reference to determine energy intake. As such, findings from this study alone cannot be used to adapt the current gestational weight gain guideline for women with obesity.

The study methods were rigorous in terms of the energy intake measurements, but a larger and more diverse sample size is needed to confirm the study findings.

Most J, St Amant M, Hsia DS, et al. Evidence-based recommendations for energy intake in pregnant women with obesity. J Clin Invest. 2019;129:4682-4690.

EXPERT COMMENTARY

In 2009, the Institute of Medicine, now known as the National Academy of Medicine, updated its gestational weight gain guideline. This guideline’s major difference, compared with the 1990 guideline, is a specific weight gain range for women with obesity: 5 to 9 kg, or 11 to 20 lb.¹ This weight gain range was chosen in part because it allows for a minimum weight gain that supports the growth and development of tissues (fetus, placenta, breast, uterus) and fluids (blood volume, intracellular and extracellular fluid), also known as the “fat-free” mass.

Many studies have since shown not only associations between lower-than-guideline-recommended weight gain and improved pregnancy outcomes (for example, reductions in preeclampsia and cesarean deliveries), but also increases in low birth weight for infants of women with obesity.^2,3 Although the weight gain guideline differs based on a woman’s prepregnancy body mass index, the energy requirements, or how many additional calories a woman should consume daily, are the same for all, regardless of weight prior to pregnancy: an increase by 340 to 452 kcal/day in the second and third trimesters.¹

Recently, Most and colleagues challenged this recommendation for energy requirements with results from their prospective observational study of 54 women with obesity during pregnancy.⁴ They aimed to evaluate energy intake with the energy intake-balance method (doubly labeled water and whole-room indirect calorimetry and body composition) according to tests done at 13 to 16 weeks’ gestation and 35 to 37 weeks’ gestation and according to the current National Academy of Medicine gestational weight gain guideline (inadequate, recommended, or excessive weight gain groups).⁴

Details of the study

Women who participated in this study were recruited from the Pennington Biomedical Research Center in Louisiana and were mostly multiparas (57%); about half had a college degree or higher (52%) and 41% were African American. The investigators found that gestational weight gain in their participants was similar to that found in other large epidemiologic studies in that 67% of women had excessive gestational weight gain.⁵

Findings. For women who gained the recommended amount of weight (n = 8), mean (SD) daily energy intake was 2,698 (99) kcal/day and energy expenditure was 2,824 (105) kcal/day. Therefore, to meet the recommended amount of weight gain, these women had a negative energy balance (-125 [52] kcal/day). Women with inadequate weight gain
(n = 10) also had a negative energy balance (-262 [32] kcal/day), but the difference was not significantly different compared with that in the recommended gestational weight gain group (P = .08). By contrast, women with excessive gestational weight gain (n = 36) had a mean (SD) positive energy balance of 186 (29) kcal/day.

Fat-free mass and fat mass weight gains. The body weight gains of the fat-free and fat mass compartments also were compared with linear mixed effect models among the 3 weight gain groups. There were no differences in the amount of fat-free mass gained among the 3 weight gain groups (P>.05), but women with excessive gestational weight gain had significantly higher increases in fat mass compared with the other 2 weight gain groups (P<.001).

Pregnancy outcomes. Although there were no differences in cesarean deliveries or birth weight among the 3 weight gain groups, the study was not powered to detect these differences.

Continue to: Study strengths and limitations...

Study strengths and limitations

It is important to note that this study by Most and colleagues was not a health behavior intervention for gestational weight gain. Women who participated in the study did not receive specific directions or advice on diet or physical activity. Furthermore, the study used the current gestational weight gain guideline as a reference to determine energy intake. As such, findings from this study alone cannot be used to adapt the current gestational weight gain guideline for women with obesity.

The study methods were rigorous in terms of the energy intake measurements, but a larger and more diverse sample size is needed to confirm the study findings.

Most J, St Amant M, Hsia DS, et al. Evidence-based recommendations for energy intake in pregnant women with obesity. J Clin Invest. 2019;129:4682-4690.

EXPERT COMMENTARY

In 2009, the Institute of Medicine, now known as the National Academy of Medicine, updated its gestational weight gain guideline. This guideline’s major difference, compared with the 1990 guideline, is a specific weight gain range for women with obesity: 5 to 9 kg, or 11 to 20 lb.¹ This weight gain range was chosen in part because it allows for a minimum weight gain that supports the growth and development of tissues (fetus, placenta, breast, uterus) and fluids (blood volume, intracellular and extracellular fluid), also known as the “fat-free” mass.

Many studies have since shown not only associations between lower-than-guideline-recommended weight gain and improved pregnancy outcomes (for example, reductions in preeclampsia and cesarean deliveries), but also increases in low birth weight for infants of women with obesity.^2,3 Although the weight gain guideline differs based on a woman’s prepregnancy body mass index, the energy requirements, or how many additional calories a woman should consume daily, are the same for all, regardless of weight prior to pregnancy: an increase by 340 to 452 kcal/day in the second and third trimesters.¹

Recently, Most and colleagues challenged this recommendation for energy requirements with results from their prospective observational study of 54 women with obesity during pregnancy.⁴ They aimed to evaluate energy intake with the energy intake-balance method (doubly labeled water and whole-room indirect calorimetry and body composition) according to tests done at 13 to 16 weeks’ gestation and 35 to 37 weeks’ gestation and according to the current National Academy of Medicine gestational weight gain guideline (inadequate, recommended, or excessive weight gain groups).⁴

Details of the study

Women who participated in this study were recruited from the Pennington Biomedical Research Center in Louisiana and were mostly multiparas (57%); about half had a college degree or higher (52%) and 41% were African American. The investigators found that gestational weight gain in their participants was similar to that found in other large epidemiologic studies in that 67% of women had excessive gestational weight gain.⁵

Findings. For women who gained the recommended amount of weight (n = 8), mean (SD) daily energy intake was 2,698 (99) kcal/day and energy expenditure was 2,824 (105) kcal/day. Therefore, to meet the recommended amount of weight gain, these women had a negative energy balance (-125 [52] kcal/day). Women with inadequate weight gain
(n = 10) also had a negative energy balance (-262 [32] kcal/day), but the difference was not significantly different compared with that in the recommended gestational weight gain group (P = .08). By contrast, women with excessive gestational weight gain (n = 36) had a mean (SD) positive energy balance of 186 (29) kcal/day.

Fat-free mass and fat mass weight gains. The body weight gains of the fat-free and fat mass compartments also were compared with linear mixed effect models among the 3 weight gain groups. There were no differences in the amount of fat-free mass gained among the 3 weight gain groups (P>.05), but women with excessive gestational weight gain had significantly higher increases in fat mass compared with the other 2 weight gain groups (P<.001).

Pregnancy outcomes. Although there were no differences in cesarean deliveries or birth weight among the 3 weight gain groups, the study was not powered to detect these differences.

Continue to: Study strengths and limitations...

Study strengths and limitations

It is important to note that this study by Most and colleagues was not a health behavior intervention for gestational weight gain. Women who participated in the study did not receive specific directions or advice on diet or physical activity. Furthermore, the study used the current gestational weight gain guideline as a reference to determine energy intake. As such, findings from this study alone cannot be used to adapt the current gestational weight gain guideline for women with obesity.

The study methods were rigorous in terms of the energy intake measurements, but a larger and more diverse sample size is needed to confirm the study findings.

With the novel coronavirus (COVID-19) monopolizing the news cycle, fear and misinformation are at an all-time high. Public health officials and physicians are accelerating education outreach to the public to address misinformation, and identify and care for patients who may have been exposed to the virus.

In times of public health crises, pregnant women have unique and pressing concerns about their personal health and the health of their unborn children. While not often mentioned in major news coverage, obstetricians play a critical role during health crises because of their uniquely personal role with patients during all stages of pregnancy, providing this vulnerable population with the most up-to-date information and following the latest guidelines for recommended care.

Unfortunately, COVID-19 is breaking unfamiliar new ground. We know that pregnant women are at higher risk for viral infection – annually, influenza is a grim reminder that pregnant women are more immunocompromised than the general public – but we do not yet have data to confirm or refute that pregnant women have a higher susceptibility to COVID-19 than the rest of the adult population. We also do not know enough about COVID-19 transmission, including whether the virus can cross the transplacental barrier to affect a fetus, or whether it can be transmitted through breast milk. 

As private practice community obstetricians work to protect their patients during this public health crisis, Ob hospitalists can play an important role in supporting them in the provision of patient care. 

First, Ob hospitalists are highly-trained specialists who can help ensure that pregnant patients who seek care at the hospital – either with viral symptoms or with separate pregnancy-related concerns – are protected during triage until the treating community obstetrician can take the reins.

When a pregnant woman presents at a hospital, in most cases she will bypass the ED and instead be sent directly to the labor and delivery (L&D) unit. During a viral outbreak, there are two major concerns with this approach. For one thing, it means an immunocompromised woman is being sent through the hospital to get to L&D, and along the path, is exposed to every airborne pathogen in the facility (and, if she is already infected, exposes others along the way). In addition, in hospitals without an Ob hospitalist on site, the patient generally is not immediately triaged by a physician, physician’s assistant, or nurse practitioner upon arrival because those clinicians are not consistently on site in L&D.

In times of viral pandemics, new approaches are warranted. For hospitals with contracted L&D management with hospitalists, hospitalists work closely with department heads to implement protocols loosely based on the Emergency Severity Index (ESI) model established by the Agency for Healthcare Research and Quality. Just as the ESI algorithm guides clinical stratification of patients, in times of reported viral outbreaks, L&D should consider triage of all pregnant women at higher levels of acuity, regardless of presentation status. In particular, if they show clinical symptoms, they should be masked, accompanied to the L&D unit by protected personnel, separated from other patients in areas of forced proximity such as hallways and elevators, and triaged in a secure single-patient room with a closed door (ideally at negative pressure relative to the surrounding areas). 

If the patient has traveled to an area of outbreak, reports exposure to travelers who have visited high-risk areas, has had contact with individuals who tested positive for COVID-19, or exhibits any clinical symptoms of COVID-19 (fever, dry cough, fatigue, etc.), her care management should adhere to standing hospital emergency protocols. Following consultation with the assigned community obstetrician, the Ob hospitalist and hospital staff should contact their local/state health departments immediately for all cases of patients who show symptoms to determine if the patient meets requirements for a person under investigation (PUI) for COVID-19. The state/local health department will work with clinicians to collect, store, and ship clinical specimens appropriately. Very ill patients may need to be treated in an intensive care setting where respiratory status can be closely monitored.

At Ob Hospitalist Group, our body of evidence from our large national footprint has informed the development of standard sets of protocols for delivery complications such as preeclampsia and postpartum hemorrhage, as well as a cesarean section reduction toolkit to combat medically unnecessary cesarean sections. OB hospitalists therefore can assist with refining COVID-19 protocols specifically for the L&D setting, using evidence-based data to tailor protocols to address public health emergencies as they evolve.

The second way that Ob hospitalists can support their colleagues is by covering L&D 24/7 so that community obstetricians can focus on other pressing medical needs. From our experience with other outbreaks such as severe acute respiratory syndrome (SARS) and influenza, we anticipate that obstetricians in private practice likely will have their hands full juggling a regular patient load, fielding calls from concerned patients, and caring for infected or ill patients who are being treated in an outpatient setting. Adding to that plate the need to rush to the hospital to clinically assess a patient for COVID-19 or for a delivery only compounds stress and exhaustion. At Ob Hospitalist Group, our hospitalist programs provide coverage and support to community obstetricians until they can arrive at the hospital or when the woman has no assigned obstetrician, reducing the pressure on community obstetricians to rush through their schedules.

Diagnostic and pharmaceutical companies are collaborating with public health officials to expedite diagnostic testing staff, hospital treatment capacity, vaccines, and even early therapies that may help to minimize severity. But right now, as clinicians work to protect their vulnerable patients, a close collaboration between community obstetricians and Ob hospitalists will help to keep patients and health care personnel safe and healthy – a goal that should apply not only to public health crises, but to the provision of maternal care every day.
 

Dr. Simon is chief medical officer at Ob Hospitalist Group (OBHG), is a board-certified ob.gyn., and former head of the department of obstetrics and gynecology for a U.S. hospital. He has no relevant conflicts of interest or financial disclosures. Email him at [email protected].

With the novel coronavirus (COVID-19) monopolizing the news cycle, fear and misinformation are at an all-time high. Public health officials and physicians are accelerating education outreach to the public to address misinformation, and identify and care for patients who may have been exposed to the virus.

In times of public health crises, pregnant women have unique and pressing concerns about their personal health and the health of their unborn children. While not often mentioned in major news coverage, obstetricians play a critical role during health crises because of their uniquely personal role with patients during all stages of pregnancy, providing this vulnerable population with the most up-to-date information and following the latest guidelines for recommended care.

Unfortunately, COVID-19 is breaking unfamiliar new ground. We know that pregnant women are at higher risk for viral infection – annually, influenza is a grim reminder that pregnant women are more immunocompromised than the general public – but we do not yet have data to confirm or refute that pregnant women have a higher susceptibility to COVID-19 than the rest of the adult population. We also do not know enough about COVID-19 transmission, including whether the virus can cross the transplacental barrier to affect a fetus, or whether it can be transmitted through breast milk. 

As private practice community obstetricians work to protect their patients during this public health crisis, Ob hospitalists can play an important role in supporting them in the provision of patient care. 

First, Ob hospitalists are highly-trained specialists who can help ensure that pregnant patients who seek care at the hospital – either with viral symptoms or with separate pregnancy-related concerns – are protected during triage until the treating community obstetrician can take the reins.

When a pregnant woman presents at a hospital, in most cases she will bypass the ED and instead be sent directly to the labor and delivery (L&D) unit. During a viral outbreak, there are two major concerns with this approach. For one thing, it means an immunocompromised woman is being sent through the hospital to get to L&D, and along the path, is exposed to every airborne pathogen in the facility (and, if she is already infected, exposes others along the way). In addition, in hospitals without an Ob hospitalist on site, the patient generally is not immediately triaged by a physician, physician’s assistant, or nurse practitioner upon arrival because those clinicians are not consistently on site in L&D.

In times of viral pandemics, new approaches are warranted. For hospitals with contracted L&D management with hospitalists, hospitalists work closely with department heads to implement protocols loosely based on the Emergency Severity Index (ESI) model established by the Agency for Healthcare Research and Quality. Just as the ESI algorithm guides clinical stratification of patients, in times of reported viral outbreaks, L&D should consider triage of all pregnant women at higher levels of acuity, regardless of presentation status. In particular, if they show clinical symptoms, they should be masked, accompanied to the L&D unit by protected personnel, separated from other patients in areas of forced proximity such as hallways and elevators, and triaged in a secure single-patient room with a closed door (ideally at negative pressure relative to the surrounding areas). 

If the patient has traveled to an area of outbreak, reports exposure to travelers who have visited high-risk areas, has had contact with individuals who tested positive for COVID-19, or exhibits any clinical symptoms of COVID-19 (fever, dry cough, fatigue, etc.), her care management should adhere to standing hospital emergency protocols. Following consultation with the assigned community obstetrician, the Ob hospitalist and hospital staff should contact their local/state health departments immediately for all cases of patients who show symptoms to determine if the patient meets requirements for a person under investigation (PUI) for COVID-19. The state/local health department will work with clinicians to collect, store, and ship clinical specimens appropriately. Very ill patients may need to be treated in an intensive care setting where respiratory status can be closely monitored.

At Ob Hospitalist Group, our body of evidence from our large national footprint has informed the development of standard sets of protocols for delivery complications such as preeclampsia and postpartum hemorrhage, as well as a cesarean section reduction toolkit to combat medically unnecessary cesarean sections. OB hospitalists therefore can assist with refining COVID-19 protocols specifically for the L&D setting, using evidence-based data to tailor protocols to address public health emergencies as they evolve.

The second way that Ob hospitalists can support their colleagues is by covering L&D 24/7 so that community obstetricians can focus on other pressing medical needs. From our experience with other outbreaks such as severe acute respiratory syndrome (SARS) and influenza, we anticipate that obstetricians in private practice likely will have their hands full juggling a regular patient load, fielding calls from concerned patients, and caring for infected or ill patients who are being treated in an outpatient setting. Adding to that plate the need to rush to the hospital to clinically assess a patient for COVID-19 or for a delivery only compounds stress and exhaustion. At Ob Hospitalist Group, our hospitalist programs provide coverage and support to community obstetricians until they can arrive at the hospital or when the woman has no assigned obstetrician, reducing the pressure on community obstetricians to rush through their schedules.

Diagnostic and pharmaceutical companies are collaborating with public health officials to expedite diagnostic testing staff, hospital treatment capacity, vaccines, and even early therapies that may help to minimize severity. But right now, as clinicians work to protect their vulnerable patients, a close collaboration between community obstetricians and Ob hospitalists will help to keep patients and health care personnel safe and healthy – a goal that should apply not only to public health crises, but to the provision of maternal care every day.
 

Dr. Simon is chief medical officer at Ob Hospitalist Group (OBHG), is a board-certified ob.gyn., and former head of the department of obstetrics and gynecology for a U.S. hospital. He has no relevant conflicts of interest or financial disclosures. Email him at [email protected].

With the novel coronavirus (COVID-19) monopolizing the news cycle, fear and misinformation are at an all-time high. Public health officials and physicians are accelerating education outreach to the public to address misinformation, and identify and care for patients who may have been exposed to the virus.

In times of public health crises, pregnant women have unique and pressing concerns about their personal health and the health of their unborn children. While not often mentioned in major news coverage, obstetricians play a critical role during health crises because of their uniquely personal role with patients during all stages of pregnancy, providing this vulnerable population with the most up-to-date information and following the latest guidelines for recommended care.

Unfortunately, COVID-19 is breaking unfamiliar new ground. We know that pregnant women are at higher risk for viral infection – annually, influenza is a grim reminder that pregnant women are more immunocompromised than the general public – but we do not yet have data to confirm or refute that pregnant women have a higher susceptibility to COVID-19 than the rest of the adult population. We also do not know enough about COVID-19 transmission, including whether the virus can cross the transplacental barrier to affect a fetus, or whether it can be transmitted through breast milk. 

As private practice community obstetricians work to protect their patients during this public health crisis, Ob hospitalists can play an important role in supporting them in the provision of patient care. 

First, Ob hospitalists are highly-trained specialists who can help ensure that pregnant patients who seek care at the hospital – either with viral symptoms or with separate pregnancy-related concerns – are protected during triage until the treating community obstetrician can take the reins.

When a pregnant woman presents at a hospital, in most cases she will bypass the ED and instead be sent directly to the labor and delivery (L&D) unit. During a viral outbreak, there are two major concerns with this approach. For one thing, it means an immunocompromised woman is being sent through the hospital to get to L&D, and along the path, is exposed to every airborne pathogen in the facility (and, if she is already infected, exposes others along the way). In addition, in hospitals without an Ob hospitalist on site, the patient generally is not immediately triaged by a physician, physician’s assistant, or nurse practitioner upon arrival because those clinicians are not consistently on site in L&D.

In times of viral pandemics, new approaches are warranted. For hospitals with contracted L&D management with hospitalists, hospitalists work closely with department heads to implement protocols loosely based on the Emergency Severity Index (ESI) model established by the Agency for Healthcare Research and Quality. Just as the ESI algorithm guides clinical stratification of patients, in times of reported viral outbreaks, L&D should consider triage of all pregnant women at higher levels of acuity, regardless of presentation status. In particular, if they show clinical symptoms, they should be masked, accompanied to the L&D unit by protected personnel, separated from other patients in areas of forced proximity such as hallways and elevators, and triaged in a secure single-patient room with a closed door (ideally at negative pressure relative to the surrounding areas). 

If the patient has traveled to an area of outbreak, reports exposure to travelers who have visited high-risk areas, has had contact with individuals who tested positive for COVID-19, or exhibits any clinical symptoms of COVID-19 (fever, dry cough, fatigue, etc.), her care management should adhere to standing hospital emergency protocols. Following consultation with the assigned community obstetrician, the Ob hospitalist and hospital staff should contact their local/state health departments immediately for all cases of patients who show symptoms to determine if the patient meets requirements for a person under investigation (PUI) for COVID-19. The state/local health department will work with clinicians to collect, store, and ship clinical specimens appropriately. Very ill patients may need to be treated in an intensive care setting where respiratory status can be closely monitored.

At Ob Hospitalist Group, our body of evidence from our large national footprint has informed the development of standard sets of protocols for delivery complications such as preeclampsia and postpartum hemorrhage, as well as a cesarean section reduction toolkit to combat medically unnecessary cesarean sections. OB hospitalists therefore can assist with refining COVID-19 protocols specifically for the L&D setting, using evidence-based data to tailor protocols to address public health emergencies as they evolve.

The second way that Ob hospitalists can support their colleagues is by covering L&D 24/7 so that community obstetricians can focus on other pressing medical needs. From our experience with other outbreaks such as severe acute respiratory syndrome (SARS) and influenza, we anticipate that obstetricians in private practice likely will have their hands full juggling a regular patient load, fielding calls from concerned patients, and caring for infected or ill patients who are being treated in an outpatient setting. Adding to that plate the need to rush to the hospital to clinically assess a patient for COVID-19 or for a delivery only compounds stress and exhaustion. At Ob Hospitalist Group, our hospitalist programs provide coverage and support to community obstetricians until they can arrive at the hospital or when the woman has no assigned obstetrician, reducing the pressure on community obstetricians to rush through their schedules.

Diagnostic and pharmaceutical companies are collaborating with public health officials to expedite diagnostic testing staff, hospital treatment capacity, vaccines, and even early therapies that may help to minimize severity. But right now, as clinicians work to protect their vulnerable patients, a close collaboration between community obstetricians and Ob hospitalists will help to keep patients and health care personnel safe and healthy – a goal that should apply not only to public health crises, but to the provision of maternal care every day.
 

Dr. Simon is chief medical officer at Ob Hospitalist Group (OBHG), is a board-certified ob.gyn., and former head of the department of obstetrics and gynecology for a U.S. hospital. He has no relevant conflicts of interest or financial disclosures. Email him at [email protected].

GRAPEVINE, TEX. – An enhanced recovery after surgery (ERAS) pathway for cesarean delivery decreased postoperative opioid usage by 62% in one health care organization, researchers reported at the Pregnancy Meeting. The protocol incorporates a stepwise approach to pain control with no scheduled postoperative opioids.

Jake Remaly/MDedge News

Abington Jefferson Health, which includes two hospitals in Pennsylvania, implemented an ERAS pathway for all cesarean deliveries in October 2018. Before implementing the protocol, median total postoperative opioid use per patient was 180.3 morphine milligram equivalents (MME); after, it was 30 MME, Kathryn Ruymann, MD, said at the meeting sponsored by the Society for Maternal-Fetal Medicine. Dr. Ruymann is an obstetrics and gynecology resident at Abington Jefferson Health.

Prior to the ERAS protocol, 99%-100% of patients took an opioid during the postoperative period. “With ERAS, 26% of patients never took an opioid during the postop period,” Dr. Ruymann and her associates reported. “Pain scores decreased with ERAS for postoperative days 1-3 and remained unchanged on day 4.”

One in 300 opioid-naive patients who receives opioids after cesarean delivery becomes a persistent user, one study has shown (Am J Obstet Gynecol. 2016 Sep; 215(3):353.e1-18). “ERAS pathways integrate evidence-based interventions before, during, and after surgery to optimize outcomes, specifically to decrease postoperative opioid use,” the researchers said.

While other surgical fields have adopted ERAS pathways, more research is needed in obstetrics, said Dr. Ruymann. More than 4,500 women deliver at Abington Jefferson Health each year, and about a third undergo cesarean deliveries.

The organization’s ERAS pathway incorporates preoperative education, fasting guidelines, and intraoperative analgesia, nausea prophylaxis, and antimicrobial therapy. Under the new protocol, postoperative analgesia includes scheduled administration of nonopioid medications, including celecoxib and acetaminophen. In addition, patients may take 5-10 mg of oxycodone orally every 4 hours as needed, and hydromorphone 0.4 mg IV as needed may be used for refractory pain. In addition, patients should resume eating as soon as tolerated and be out of bed within 4 hours after surgery, according to the protocol. Postoperative management of pruritus and instructions on how to wean off opioids at home are among the other elements of the enhanced recovery plan.

To examine postoperative opioid usage before and after implementation of the ERAS pathway, the investigators conducted a retrospective cohort study of 316 women who underwent cesarean delivery 3 months before the start of the ERAS pathway and 267 who underwent cesarean delivery 3 months after. The researchers used an application developed in Qlik Sense, a data analytics platform, to calculate opioid usage.

Mean postoperative opioid use decreased by 62%. The reduction in opioid use remained 8 months after starting the ERAS pathway.

“An ERAS pathway for [cesarean delivery] decreases postoperative opioid usage by integrating a multimodal stepwise approach to pain control and recovery,” the researchers said. “Standardized order sets and departmentwide education were crucial in the success of ERAS. Additional research is needed to evaluate the impact of unique components of ERAS in order to optimize this pathway.”

The researchers had no disclosures.

[email protected]

SOURCE: Ruymann K et al. Am J Obstet Gynecol. 2020 Jan;222(1):S212, Abstract 315.

GRAPEVINE, TEX. – An enhanced recovery after surgery (ERAS) pathway for cesarean delivery decreased postoperative opioid usage by 62% in one health care organization, researchers reported at the Pregnancy Meeting. The protocol incorporates a stepwise approach to pain control with no scheduled postoperative opioids.

Jake Remaly/MDedge News

Abington Jefferson Health, which includes two hospitals in Pennsylvania, implemented an ERAS pathway for all cesarean deliveries in October 2018. Before implementing the protocol, median total postoperative opioid use per patient was 180.3 morphine milligram equivalents (MME); after, it was 30 MME, Kathryn Ruymann, MD, said at the meeting sponsored by the Society for Maternal-Fetal Medicine. Dr. Ruymann is an obstetrics and gynecology resident at Abington Jefferson Health.

Prior to the ERAS protocol, 99%-100% of patients took an opioid during the postoperative period. “With ERAS, 26% of patients never took an opioid during the postop period,” Dr. Ruymann and her associates reported. “Pain scores decreased with ERAS for postoperative days 1-3 and remained unchanged on day 4.”

One in 300 opioid-naive patients who receives opioids after cesarean delivery becomes a persistent user, one study has shown (Am J Obstet Gynecol. 2016 Sep; 215(3):353.e1-18). “ERAS pathways integrate evidence-based interventions before, during, and after surgery to optimize outcomes, specifically to decrease postoperative opioid use,” the researchers said.

While other surgical fields have adopted ERAS pathways, more research is needed in obstetrics, said Dr. Ruymann. More than 4,500 women deliver at Abington Jefferson Health each year, and about a third undergo cesarean deliveries.

The organization’s ERAS pathway incorporates preoperative education, fasting guidelines, and intraoperative analgesia, nausea prophylaxis, and antimicrobial therapy. Under the new protocol, postoperative analgesia includes scheduled administration of nonopioid medications, including celecoxib and acetaminophen. In addition, patients may take 5-10 mg of oxycodone orally every 4 hours as needed, and hydromorphone 0.4 mg IV as needed may be used for refractory pain. In addition, patients should resume eating as soon as tolerated and be out of bed within 4 hours after surgery, according to the protocol. Postoperative management of pruritus and instructions on how to wean off opioids at home are among the other elements of the enhanced recovery plan.

To examine postoperative opioid usage before and after implementation of the ERAS pathway, the investigators conducted a retrospective cohort study of 316 women who underwent cesarean delivery 3 months before the start of the ERAS pathway and 267 who underwent cesarean delivery 3 months after. The researchers used an application developed in Qlik Sense, a data analytics platform, to calculate opioid usage.

Mean postoperative opioid use decreased by 62%. The reduction in opioid use remained 8 months after starting the ERAS pathway.

“An ERAS pathway for [cesarean delivery] decreases postoperative opioid usage by integrating a multimodal stepwise approach to pain control and recovery,” the researchers said. “Standardized order sets and departmentwide education were crucial in the success of ERAS. Additional research is needed to evaluate the impact of unique components of ERAS in order to optimize this pathway.”

The researchers had no disclosures.

[email protected]

SOURCE: Ruymann K et al. Am J Obstet Gynecol. 2020 Jan;222(1):S212, Abstract 315.

GRAPEVINE, TEX. – An enhanced recovery after surgery (ERAS) pathway for cesarean delivery decreased postoperative opioid usage by 62% in one health care organization, researchers reported at the Pregnancy Meeting. The protocol incorporates a stepwise approach to pain control with no scheduled postoperative opioids.

Jake Remaly/MDedge News

Abington Jefferson Health, which includes two hospitals in Pennsylvania, implemented an ERAS pathway for all cesarean deliveries in October 2018. Before implementing the protocol, median total postoperative opioid use per patient was 180.3 morphine milligram equivalents (MME); after, it was 30 MME, Kathryn Ruymann, MD, said at the meeting sponsored by the Society for Maternal-Fetal Medicine. Dr. Ruymann is an obstetrics and gynecology resident at Abington Jefferson Health.

Prior to the ERAS protocol, 99%-100% of patients took an opioid during the postoperative period. “With ERAS, 26% of patients never took an opioid during the postop period,” Dr. Ruymann and her associates reported. “Pain scores decreased with ERAS for postoperative days 1-3 and remained unchanged on day 4.”

One in 300 opioid-naive patients who receives opioids after cesarean delivery becomes a persistent user, one study has shown (Am J Obstet Gynecol. 2016 Sep; 215(3):353.e1-18). “ERAS pathways integrate evidence-based interventions before, during, and after surgery to optimize outcomes, specifically to decrease postoperative opioid use,” the researchers said.

While other surgical fields have adopted ERAS pathways, more research is needed in obstetrics, said Dr. Ruymann. More than 4,500 women deliver at Abington Jefferson Health each year, and about a third undergo cesarean deliveries.

The organization’s ERAS pathway incorporates preoperative education, fasting guidelines, and intraoperative analgesia, nausea prophylaxis, and antimicrobial therapy. Under the new protocol, postoperative analgesia includes scheduled administration of nonopioid medications, including celecoxib and acetaminophen. In addition, patients may take 5-10 mg of oxycodone orally every 4 hours as needed, and hydromorphone 0.4 mg IV as needed may be used for refractory pain. In addition, patients should resume eating as soon as tolerated and be out of bed within 4 hours after surgery, according to the protocol. Postoperative management of pruritus and instructions on how to wean off opioids at home are among the other elements of the enhanced recovery plan.

To examine postoperative opioid usage before and after implementation of the ERAS pathway, the investigators conducted a retrospective cohort study of 316 women who underwent cesarean delivery 3 months before the start of the ERAS pathway and 267 who underwent cesarean delivery 3 months after. The researchers used an application developed in Qlik Sense, a data analytics platform, to calculate opioid usage.

Mean postoperative opioid use decreased by 62%. The reduction in opioid use remained 8 months after starting the ERAS pathway.

“An ERAS pathway for [cesarean delivery] decreases postoperative opioid usage by integrating a multimodal stepwise approach to pain control and recovery,” the researchers said. “Standardized order sets and departmentwide education were crucial in the success of ERAS. Additional research is needed to evaluate the impact of unique components of ERAS in order to optimize this pathway.”

The researchers had no disclosures.

[email protected]

SOURCE: Ruymann K et al. Am J Obstet Gynecol. 2020 Jan;222(1):S212, Abstract 315.

GRAPEVINE, TEXAS – Performing a total salpingectomy at the time of cesarean delivery added just over 6 minutes of operative time, compared with cesarean delivery and conventional sterilization, according to a recent systematic review and meta-analysis.

Although surgery took a little longer with salpingectomy, there was no increase in surgical complications, Jared Roeckner, MD, said in an interview at the Pregnancy Meeting, sponsored by the Society for Maternal-Fetal Medicine. “Total salpingectomy could provide an effective means of contraception and reduce the risk of future ovarian cancer,” he said.

Dr. Roeckner, a maternal-fetal medicine fellow at the University of South Florida, Tampa, explained in an interview that the systematic review and meta-analysis comprised 11 studies and included 320,443 women who received salpingectomy or standard sterilization methods. Eight cohort studies and three randomized controlled trials were included in the analysis, which was presented in a poster session at the meeting and in a simultaneous publication in Obstetrics & Gynecology.

The review’s results, wrote Dr. Roeckner and colleagues, “suggest total salpingectomy should be offered to women interested in ovarian cancer risk-reduction interventions [who] plan to undergo sterilization at the time of cesarean delivery.”

The eight cohort studies included 7,303 women. In these studies, women who received total salpingectomy at the time of cesarean delivery had operative time – defined as the time from skin incision to skin closure – 6.3 minutes longer than women who received a standard sterilization method (95% confidence interval, 3.5-9.1). The difference in duration of procedure for the three randomized controlled trials was not statistically significant between the two procedures.

Dr. Roeckner and colleagues noted that two of the randomized controlled trials reported times for the sterilization procedures. One study found a duration of 5.6 minutes for salpingectomy with a bipolar device and 6.1 minutes for tubal interruption; the other study compared salpingectomy with suture ligation and tubal interruption, finding operative times of 18.5 and 6.9 minutes, respectively.

In addition to the primary outcome of operative time, Dr. Roeckner and colleagues looked at rates of a variety of complications. These included transfusion, estimated blood loss, change in hemoglobin, wound infection, internal organ damage, readmission, reoperation, and length of stay. Salpingectomy was not associated with higher rates of any of these complications.

“Our main finding was that salpingectomy at the time of cesarean delivery may be associated with a small increase in operative time, but it doesn’t appear to be associated with an increased rate of surgical complications,” the researchers wrote.

One concern that’s been raised about the strategy of salpingectomy is the possibility of reduction of ovarian reserve related to decreased blood supply to the ovaries. However, noted Dr. Roeckner and coinvestigators, other studies have not shown decreases in anti-Müllerian hormone levels or other real-world signals for reduced ovarian reserve.

It’s true, the investigators acknowledged, that there is no possibility for reanastomosis and future fertility with salpingectomy. However, they observed that if the possibility for future fertility exists, conventional tubal ligation should not be performed.

Despite the thoroughness of the review and the investigators’ emphasis on adhering to best practices for systematic reviews and meta-analysis, they acknowledged that there were few studies, which resulted in some difficulties with statistical power. Still, they said, “there does not appear to be a trend toward increased complications among the salpingectomy cohort.”

Dr. Roeckner reported no outside sources of funding and no conflicts of interest.

[email protected]

SOURCE: Roeckner J et al. Pregnancy Meeting, Abstract P180; Obstet Gynecol. 2020 Feb;135:3:550-7.

GRAPEVINE, TEXAS – Performing a total salpingectomy at the time of cesarean delivery added just over 6 minutes of operative time, compared with cesarean delivery and conventional sterilization, according to a recent systematic review and meta-analysis.

Although surgery took a little longer with salpingectomy, there was no increase in surgical complications, Jared Roeckner, MD, said in an interview at the Pregnancy Meeting, sponsored by the Society for Maternal-Fetal Medicine. “Total salpingectomy could provide an effective means of contraception and reduce the risk of future ovarian cancer,” he said.

Dr. Roeckner, a maternal-fetal medicine fellow at the University of South Florida, Tampa, explained in an interview that the systematic review and meta-analysis comprised 11 studies and included 320,443 women who received salpingectomy or standard sterilization methods. Eight cohort studies and three randomized controlled trials were included in the analysis, which was presented in a poster session at the meeting and in a simultaneous publication in Obstetrics & Gynecology.

The review’s results, wrote Dr. Roeckner and colleagues, “suggest total salpingectomy should be offered to women interested in ovarian cancer risk-reduction interventions [who] plan to undergo sterilization at the time of cesarean delivery.”

The eight cohort studies included 7,303 women. In these studies, women who received total salpingectomy at the time of cesarean delivery had operative time – defined as the time from skin incision to skin closure – 6.3 minutes longer than women who received a standard sterilization method (95% confidence interval, 3.5-9.1). The difference in duration of procedure for the three randomized controlled trials was not statistically significant between the two procedures.

Dr. Roeckner and colleagues noted that two of the randomized controlled trials reported times for the sterilization procedures. One study found a duration of 5.6 minutes for salpingectomy with a bipolar device and 6.1 minutes for tubal interruption; the other study compared salpingectomy with suture ligation and tubal interruption, finding operative times of 18.5 and 6.9 minutes, respectively.

In addition to the primary outcome of operative time, Dr. Roeckner and colleagues looked at rates of a variety of complications. These included transfusion, estimated blood loss, change in hemoglobin, wound infection, internal organ damage, readmission, reoperation, and length of stay. Salpingectomy was not associated with higher rates of any of these complications.

“Our main finding was that salpingectomy at the time of cesarean delivery may be associated with a small increase in operative time, but it doesn’t appear to be associated with an increased rate of surgical complications,” the researchers wrote.

One concern that’s been raised about the strategy of salpingectomy is the possibility of reduction of ovarian reserve related to decreased blood supply to the ovaries. However, noted Dr. Roeckner and coinvestigators, other studies have not shown decreases in anti-Müllerian hormone levels or other real-world signals for reduced ovarian reserve.

It’s true, the investigators acknowledged, that there is no possibility for reanastomosis and future fertility with salpingectomy. However, they observed that if the possibility for future fertility exists, conventional tubal ligation should not be performed.

Despite the thoroughness of the review and the investigators’ emphasis on adhering to best practices for systematic reviews and meta-analysis, they acknowledged that there were few studies, which resulted in some difficulties with statistical power. Still, they said, “there does not appear to be a trend toward increased complications among the salpingectomy cohort.”

Dr. Roeckner reported no outside sources of funding and no conflicts of interest.

[email protected]

SOURCE: Roeckner J et al. Pregnancy Meeting, Abstract P180; Obstet Gynecol. 2020 Feb;135:3:550-7.

GRAPEVINE, TEXAS – Performing a total salpingectomy at the time of cesarean delivery added just over 6 minutes of operative time, compared with cesarean delivery and conventional sterilization, according to a recent systematic review and meta-analysis.

Although surgery took a little longer with salpingectomy, there was no increase in surgical complications, Jared Roeckner, MD, said in an interview at the Pregnancy Meeting, sponsored by the Society for Maternal-Fetal Medicine. “Total salpingectomy could provide an effective means of contraception and reduce the risk of future ovarian cancer,” he said.

Dr. Roeckner, a maternal-fetal medicine fellow at the University of South Florida, Tampa, explained in an interview that the systematic review and meta-analysis comprised 11 studies and included 320,443 women who received salpingectomy or standard sterilization methods. Eight cohort studies and three randomized controlled trials were included in the analysis, which was presented in a poster session at the meeting and in a simultaneous publication in Obstetrics & Gynecology.

The review’s results, wrote Dr. Roeckner and colleagues, “suggest total salpingectomy should be offered to women interested in ovarian cancer risk-reduction interventions [who] plan to undergo sterilization at the time of cesarean delivery.”

The eight cohort studies included 7,303 women. In these studies, women who received total salpingectomy at the time of cesarean delivery had operative time – defined as the time from skin incision to skin closure – 6.3 minutes longer than women who received a standard sterilization method (95% confidence interval, 3.5-9.1). The difference in duration of procedure for the three randomized controlled trials was not statistically significant between the two procedures.

Dr. Roeckner and colleagues noted that two of the randomized controlled trials reported times for the sterilization procedures. One study found a duration of 5.6 minutes for salpingectomy with a bipolar device and 6.1 minutes for tubal interruption; the other study compared salpingectomy with suture ligation and tubal interruption, finding operative times of 18.5 and 6.9 minutes, respectively.

In addition to the primary outcome of operative time, Dr. Roeckner and colleagues looked at rates of a variety of complications. These included transfusion, estimated blood loss, change in hemoglobin, wound infection, internal organ damage, readmission, reoperation, and length of stay. Salpingectomy was not associated with higher rates of any of these complications.

“Our main finding was that salpingectomy at the time of cesarean delivery may be associated with a small increase in operative time, but it doesn’t appear to be associated with an increased rate of surgical complications,” the researchers wrote.

One concern that’s been raised about the strategy of salpingectomy is the possibility of reduction of ovarian reserve related to decreased blood supply to the ovaries. However, noted Dr. Roeckner and coinvestigators, other studies have not shown decreases in anti-Müllerian hormone levels or other real-world signals for reduced ovarian reserve.

It’s true, the investigators acknowledged, that there is no possibility for reanastomosis and future fertility with salpingectomy. However, they observed that if the possibility for future fertility exists, conventional tubal ligation should not be performed.

Despite the thoroughness of the review and the investigators’ emphasis on adhering to best practices for systematic reviews and meta-analysis, they acknowledged that there were few studies, which resulted in some difficulties with statistical power. Still, they said, “there does not appear to be a trend toward increased complications among the salpingectomy cohort.”

Dr. Roeckner reported no outside sources of funding and no conflicts of interest.

[email protected]

SOURCE: Roeckner J et al. Pregnancy Meeting, Abstract P180; Obstet Gynecol. 2020 Feb;135:3:550-7.

A new guideline from the American College of Rheumatology offers the organization’s first clinical recommendations on how to manage reproductive health issues in patients with rheumatic and musculoskeletal diseases (RMDs).

Bruce Jancin/MDedge News

“With the development of this guideline, the ACR recognizes the key role of clinical rheumatologists not only in managing disease activity but also in understanding the interactions of RMDs and their therapies in the context of reproductive health,” wrote Lisa R. Sammaritano, MD, of Weill Cornell Medicine and the Hospital for Special Surgery in New York, and coauthors. The guideline was published in Arthritis & Rheumatology.

To develop an evidence-based guideline on reproductive health in RMD patients, the researchers embarked on a systematic review of studies in areas like contraception, pregnancy and lactation, assisted reproductive technology (ART), fertility preservation, and hormone therapy. The guideline contains 12 ungraded good practice statements and 131 graded recommendations, all developed through the Grading of Recommendations Assessment, Development, and Evaluation methodology.

In counseling patients about these areas of care, the guideline says that rheumatologists and other clinicians “must collaborate with specialists in the fields of obstetrics-gynecology, maternal-fetal medicine, and reproductive endocrinology and infertility.”

Mitchel L. Zoler/Frontline Medical News

“One thing this guideline does well is highlight the importance of involving maternal-fetal medicine colleagues,” Alison Cahill, MD, a professor in the department of women’s health at the University of Texas at Austin and a maternal-fetal medicine specialist within UT Health Austin’s Women’s Health Institute, said when asked for comment on the guideline. “We’re always very happy to see patients ahead of time who are planning pregnancy to be able to discuss what the care plan would look like. And specifically, to address medications, if required, for their rheumatologic care.

“As we learn more and more,” she added, “we’ve come to understand that most treatments and medications are actually safe or relatively safe to take in pregnancy. Certainly, the benefit of taking them outweighs any small or theoretic risks. On the flip side, the guideline does a nice job of highlighting the importance of good disease control, both at the time of conception and during pregnancy.”
 

Contraception

In regard to contraception, the guideline strongly recommends the use of effective contraceptives – with a conditional recommendation of IUDs or a subdermal progestin implant – in fertile women with a RMD who have neither systemic lupus erythematosus (SLE) nor positive antiphospholipid antibody (aPL). They also strongly recommend discussing the use of emergency contraception with all RMD patients.

For SLE patients, the guideline strongly recommends the use of effective contraceptives in those with stable or low disease activity who are not positive for aPL. They also strongly recommend progestin‐only or IUD contraceptives over combined estrogen‐progestin contraception. For aPL-positive patients, the guideline strongly recommends against combined estrogen‐progestin contraceptives and for levonorgestrel or copper IUDs or the progestin‐only pill.
 

Assisted reproductive technology

In regard to ART, the guideline strongly recommends proceeding as needed in aPL-negative women with uncomplicated, stable RMD who are on pregnancy‐compatible medications. They also strongly recommend deferring ART in any RMD patients with moderately or severely active disease.

For aPL-positive patients undergoing ART procedures, they strongly recommend prophylactic anticoagulation with heparin or low-molecular-weight heparin (LMWH) in women with obstetric antiphospholipid syndrome (APS) and therapeutic anticoagulation in women with thrombotic APS. In patients undergoing embryo and oocyte cryopreservation, they strongly recommend continuing immunosuppressive and biologic therapies – the exception being cyclophosphamide (CYC) – for anyone in stable condition.
 

Fertility preservation

In regard to fertility preservation in patients taking CYC, the guideline strongly suggests sperm cryopreservation as good practice prior to treatment. They also conditionally recommend monthly gonadotropin‐releasing hormone agonist cotherapy in premenopausal women with RMD.

Hormone therapy

In regard to menopause and hormone therapy, the guideline strongly suggests hormone therapy as good practice in postmenopausal women with RMD, without SLE or positive aPL, and who have severe vasomotor symptoms. Hormone therapy is conditionally recommended in patients with SLE, without positive aPL, and with no contraindications. For aPL-positive patients, they strongly recommend against hormone therapy in women with obstetric and/or thrombotic APS.

Pregnancy assessment and management

Among the many recommendations regarding pregnancy assessment and management, the guideline strongly suggests counseling women with RMD who are considering pregnancy to take into account the improved outcomes for pregnant women with low disease activity. They strongly recommend that women considering pregnancy should switch to pregnancy‐compatible medication and pause to assess its efficacy and tolerability before moving forward, along with strongly recommending that pregnant women with active disease initiate or continue a pregnancy‐compatible steroid‐sparing medication. They also recommend testing for anti‐Ro/SS-A and anti‐La/SS-B in women with SLE, Sjögren’s syndrome, systemic sclerosis, or rheumatoid arthritis, but only once and only before or early in the pregnancy.

For women with systemic sclerosis who develop scleroderma renal crisis during pregnancy, the authors strongly advise using ACE inhibitors or angiotensin receptor blockers “because the risk of maternal or fetal death with untreated disease is higher than the risk associated with use of these medications during pregnancy.”

Among women with SLE, the recommendations strongly call for testing either before or early in pregnancy for anticardiolipin antibody, anti–beta2-glycoprotein I, or positive lupus anticoagulant, as well as initiating or continuing hydroxychloroquine (HCQ) if possible. Starting in the first trimester, the authors also conditionally recommend that SLE patients take low-dose aspirin daily

For pregnant women who test positive for aPL but do not meet criteria for obstetric or thrombotic APS, the guideline conditionally recommends prophylactic treatment with low-dose aspirin daily to protect against preeclampsia. When obstetric APS criteria are met, the guideline strongly advises combined treatment with daily low-dose aspirin and prophylactic-dose heparin (or LMWH), as well as prophylactic-dose anticoagulation for 6-12 weeks post partum. When patients have thrombotic APS, this combination treatment should contain heparin dose at a therapeutic level throughout pregnancy and postpartum. However, the authors conditionally recommend against giving low-dose aspirin plus prophylactic-dose heparin to women without obstetric APS. For refractory obstetric APS, the guideline also contains recommendations that are conditionally against treatment with intravenous immunoglobulin or an increased LMWH dose and strongly against adding prednisone to prophylactic-dose heparin or LMWH and low-dose aspirin. In pregnant patients with primary APS, the authors conditionally advise adding HCQ to prophylactic-dose heparin or LMWH and low-dose aspirin therapy. However, women with aPL who do not meet APS criteria or have another indication for HCQ are conditionally advised against prophylactic treatment with the antimalarial.

For women with Anti-Ro/SS-A and/or anti-La/SS-B antibodies in pregnancy, there is conditional advice to use HCQ. When there is no history of an infant with complete heart block or neonatal lupus erythematosus among women with these antibodies, the guideline conditionally advises serial fetal echocardiography (less often than weekly) starting between 16 and 18 weeks and continuing through 26 weeks, but this should be weekly when there is a prior history. Treatment with oral dexamethasone 4 mg daily is conditionally advised when there is echocardiographic evidence of fetal first- or second-degree heart block, but dexamethasone is not recommended when complete heart block is present.

Finally, in regard to medication use, the authors strongly recommend that men who are planning to be fathers continue on HCQ, azathioprine, 6‐mercaptopurine, colchicine, or tumor necrosis factor inhibitors. Conditional treatment recommendations for men planning for pregnancy include methotrexate, mycophenolate mofetil/mycophenolic acid (MMF), leflunomide, sulfasalazine, calcineurin inhibitors, and NSAIDs. They also strongly recommend that this group of men discontinue CYC and thalidomide.

Pregnant women are strongly recommended to discontinue methotrexate, leflunomide (with cholestyramine washout if there are detectable serum levels of its metabolite prior to pregnancy or as soon as it is confirmed), MMF, CYC, and thalidomide within 3 months prior to conception, and they strongly recommend HCQ (in women with SLE), azathioprine/6‐mercaptopurine, colchicine, or sulfasalazine for use throughout pregnancy. They strongly recommend a combination of low‐dose aspirin and prophylactic‐dose heparin for pregnant women with obstetric APS, along with low‐dose aspirin and therapeutic‐dose heparin for women with thrombotic APS throughout pregnancy and postpartum. However, for women with SLE and those who test positive for aPL but do not meet criteria for obstetric or thrombotic APS, the authors conditionally recommend low-dose aspirin starting in the first trimester.

The guideline suggests that women with RMD should be encouraged to breastfeed if they are willing and able; they also suggest that disease control be maintained through lactation‐compatible medications and that the risks and benefits be reviewed on a patient-by-patient basis. Treatment with HCQ, colchicine, sulfasalazine, rituximab, and all tumor necrosis factor inhibitors are strongly recommended as being compatible with breastfeeding, and they strongly recommend against using CYC, leflunomide, MMF, and thalidomide while breastfeeding.

The authors acknowledged the limitations of their guideline, including the literature review being conducted on studies involving adults and an “inability to include recommendations for uncommon but important clinical situations,” including those involving transgender patients and hormonal therapies.

The authors reported numerous potential conflicts of interest, including receiving research support, consulting fees, speaking fees, and honoraria from various pharmaceutical companies.

SOURCE: Sammaritano LR et al. Arthritis Rheumatol. 2020 Feb 23. doi: 10.1002/art.41191.

A new guideline from the American College of Rheumatology offers the organization’s first clinical recommendations on how to manage reproductive health issues in patients with rheumatic and musculoskeletal diseases (RMDs).

Bruce Jancin/MDedge News

“With the development of this guideline, the ACR recognizes the key role of clinical rheumatologists not only in managing disease activity but also in understanding the interactions of RMDs and their therapies in the context of reproductive health,” wrote Lisa R. Sammaritano, MD, of Weill Cornell Medicine and the Hospital for Special Surgery in New York, and coauthors. The guideline was published in Arthritis & Rheumatology.

To develop an evidence-based guideline on reproductive health in RMD patients, the researchers embarked on a systematic review of studies in areas like contraception, pregnancy and lactation, assisted reproductive technology (ART), fertility preservation, and hormone therapy. The guideline contains 12 ungraded good practice statements and 131 graded recommendations, all developed through the Grading of Recommendations Assessment, Development, and Evaluation methodology.

In counseling patients about these areas of care, the guideline says that rheumatologists and other clinicians “must collaborate with specialists in the fields of obstetrics-gynecology, maternal-fetal medicine, and reproductive endocrinology and infertility.”

Mitchel L. Zoler/Frontline Medical News

“One thing this guideline does well is highlight the importance of involving maternal-fetal medicine colleagues,” Alison Cahill, MD, a professor in the department of women’s health at the University of Texas at Austin and a maternal-fetal medicine specialist within UT Health Austin’s Women’s Health Institute, said when asked for comment on the guideline. “We’re always very happy to see patients ahead of time who are planning pregnancy to be able to discuss what the care plan would look like. And specifically, to address medications, if required, for their rheumatologic care.

“As we learn more and more,” she added, “we’ve come to understand that most treatments and medications are actually safe or relatively safe to take in pregnancy. Certainly, the benefit of taking them outweighs any small or theoretic risks. On the flip side, the guideline does a nice job of highlighting the importance of good disease control, both at the time of conception and during pregnancy.”
 

Contraception

In regard to contraception, the guideline strongly recommends the use of effective contraceptives – with a conditional recommendation of IUDs or a subdermal progestin implant – in fertile women with a RMD who have neither systemic lupus erythematosus (SLE) nor positive antiphospholipid antibody (aPL). They also strongly recommend discussing the use of emergency contraception with all RMD patients.

For SLE patients, the guideline strongly recommends the use of effective contraceptives in those with stable or low disease activity who are not positive for aPL. They also strongly recommend progestin‐only or IUD contraceptives over combined estrogen‐progestin contraception. For aPL-positive patients, the guideline strongly recommends against combined estrogen‐progestin contraceptives and for levonorgestrel or copper IUDs or the progestin‐only pill.
 

Assisted reproductive technology

In regard to ART, the guideline strongly recommends proceeding as needed in aPL-negative women with uncomplicated, stable RMD who are on pregnancy‐compatible medications. They also strongly recommend deferring ART in any RMD patients with moderately or severely active disease.

For aPL-positive patients undergoing ART procedures, they strongly recommend prophylactic anticoagulation with heparin or low-molecular-weight heparin (LMWH) in women with obstetric antiphospholipid syndrome (APS) and therapeutic anticoagulation in women with thrombotic APS. In patients undergoing embryo and oocyte cryopreservation, they strongly recommend continuing immunosuppressive and biologic therapies – the exception being cyclophosphamide (CYC) – for anyone in stable condition.
 

Fertility preservation

In regard to fertility preservation in patients taking CYC, the guideline strongly suggests sperm cryopreservation as good practice prior to treatment. They also conditionally recommend monthly gonadotropin‐releasing hormone agonist cotherapy in premenopausal women with RMD.

Hormone therapy

In regard to menopause and hormone therapy, the guideline strongly suggests hormone therapy as good practice in postmenopausal women with RMD, without SLE or positive aPL, and who have severe vasomotor symptoms. Hormone therapy is conditionally recommended in patients with SLE, without positive aPL, and with no contraindications. For aPL-positive patients, they strongly recommend against hormone therapy in women with obstetric and/or thrombotic APS.

Pregnancy assessment and management

Among the many recommendations regarding pregnancy assessment and management, the guideline strongly suggests counseling women with RMD who are considering pregnancy to take into account the improved outcomes for pregnant women with low disease activity. They strongly recommend that women considering pregnancy should switch to pregnancy‐compatible medication and pause to assess its efficacy and tolerability before moving forward, along with strongly recommending that pregnant women with active disease initiate or continue a pregnancy‐compatible steroid‐sparing medication. They also recommend testing for anti‐Ro/SS-A and anti‐La/SS-B in women with SLE, Sjögren’s syndrome, systemic sclerosis, or rheumatoid arthritis, but only once and only before or early in the pregnancy.

For women with systemic sclerosis who develop scleroderma renal crisis during pregnancy, the authors strongly advise using ACE inhibitors or angiotensin receptor blockers “because the risk of maternal or fetal death with untreated disease is higher than the risk associated with use of these medications during pregnancy.”

Among women with SLE, the recommendations strongly call for testing either before or early in pregnancy for anticardiolipin antibody, anti–beta2-glycoprotein I, or positive lupus anticoagulant, as well as initiating or continuing hydroxychloroquine (HCQ) if possible. Starting in the first trimester, the authors also conditionally recommend that SLE patients take low-dose aspirin daily

For pregnant women who test positive for aPL but do not meet criteria for obstetric or thrombotic APS, the guideline conditionally recommends prophylactic treatment with low-dose aspirin daily to protect against preeclampsia. When obstetric APS criteria are met, the guideline strongly advises combined treatment with daily low-dose aspirin and prophylactic-dose heparin (or LMWH), as well as prophylactic-dose anticoagulation for 6-12 weeks post partum. When patients have thrombotic APS, this combination treatment should contain heparin dose at a therapeutic level throughout pregnancy and postpartum. However, the authors conditionally recommend against giving low-dose aspirin plus prophylactic-dose heparin to women without obstetric APS. For refractory obstetric APS, the guideline also contains recommendations that are conditionally against treatment with intravenous immunoglobulin or an increased LMWH dose and strongly against adding prednisone to prophylactic-dose heparin or LMWH and low-dose aspirin. In pregnant patients with primary APS, the authors conditionally advise adding HCQ to prophylactic-dose heparin or LMWH and low-dose aspirin therapy. However, women with aPL who do not meet APS criteria or have another indication for HCQ are conditionally advised against prophylactic treatment with the antimalarial.

For women with Anti-Ro/SS-A and/or anti-La/SS-B antibodies in pregnancy, there is conditional advice to use HCQ. When there is no history of an infant with complete heart block or neonatal lupus erythematosus among women with these antibodies, the guideline conditionally advises serial fetal echocardiography (less often than weekly) starting between 16 and 18 weeks and continuing through 26 weeks, but this should be weekly when there is a prior history. Treatment with oral dexamethasone 4 mg daily is conditionally advised when there is echocardiographic evidence of fetal first- or second-degree heart block, but dexamethasone is not recommended when complete heart block is present.

Finally, in regard to medication use, the authors strongly recommend that men who are planning to be fathers continue on HCQ, azathioprine, 6‐mercaptopurine, colchicine, or tumor necrosis factor inhibitors. Conditional treatment recommendations for men planning for pregnancy include methotrexate, mycophenolate mofetil/mycophenolic acid (MMF), leflunomide, sulfasalazine, calcineurin inhibitors, and NSAIDs. They also strongly recommend that this group of men discontinue CYC and thalidomide.

Pregnant women are strongly recommended to discontinue methotrexate, leflunomide (with cholestyramine washout if there are detectable serum levels of its metabolite prior to pregnancy or as soon as it is confirmed), MMF, CYC, and thalidomide within 3 months prior to conception, and they strongly recommend HCQ (in women with SLE), azathioprine/6‐mercaptopurine, colchicine, or sulfasalazine for use throughout pregnancy. They strongly recommend a combination of low‐dose aspirin and prophylactic‐dose heparin for pregnant women with obstetric APS, along with low‐dose aspirin and therapeutic‐dose heparin for women with thrombotic APS throughout pregnancy and postpartum. However, for women with SLE and those who test positive for aPL but do not meet criteria for obstetric or thrombotic APS, the authors conditionally recommend low-dose aspirin starting in the first trimester.

The guideline suggests that women with RMD should be encouraged to breastfeed if they are willing and able; they also suggest that disease control be maintained through lactation‐compatible medications and that the risks and benefits be reviewed on a patient-by-patient basis. Treatment with HCQ, colchicine, sulfasalazine, rituximab, and all tumor necrosis factor inhibitors are strongly recommended as being compatible with breastfeeding, and they strongly recommend against using CYC, leflunomide, MMF, and thalidomide while breastfeeding.

The authors acknowledged the limitations of their guideline, including the literature review being conducted on studies involving adults and an “inability to include recommendations for uncommon but important clinical situations,” including those involving transgender patients and hormonal therapies.

The authors reported numerous potential conflicts of interest, including receiving research support, consulting fees, speaking fees, and honoraria from various pharmaceutical companies.

SOURCE: Sammaritano LR et al. Arthritis Rheumatol. 2020 Feb 23. doi: 10.1002/art.41191.

A new guideline from the American College of Rheumatology offers the organization’s first clinical recommendations on how to manage reproductive health issues in patients with rheumatic and musculoskeletal diseases (RMDs).

Bruce Jancin/MDedge News

“With the development of this guideline, the ACR recognizes the key role of clinical rheumatologists not only in managing disease activity but also in understanding the interactions of RMDs and their therapies in the context of reproductive health,” wrote Lisa R. Sammaritano, MD, of Weill Cornell Medicine and the Hospital for Special Surgery in New York, and coauthors. The guideline was published in Arthritis & Rheumatology.

To develop an evidence-based guideline on reproductive health in RMD patients, the researchers embarked on a systematic review of studies in areas like contraception, pregnancy and lactation, assisted reproductive technology (ART), fertility preservation, and hormone therapy. The guideline contains 12 ungraded good practice statements and 131 graded recommendations, all developed through the Grading of Recommendations Assessment, Development, and Evaluation methodology.

In counseling patients about these areas of care, the guideline says that rheumatologists and other clinicians “must collaborate with specialists in the fields of obstetrics-gynecology, maternal-fetal medicine, and reproductive endocrinology and infertility.”

Mitchel L. Zoler/Frontline Medical News

“One thing this guideline does well is highlight the importance of involving maternal-fetal medicine colleagues,” Alison Cahill, MD, a professor in the department of women’s health at the University of Texas at Austin and a maternal-fetal medicine specialist within UT Health Austin’s Women’s Health Institute, said when asked for comment on the guideline. “We’re always very happy to see patients ahead of time who are planning pregnancy to be able to discuss what the care plan would look like. And specifically, to address medications, if required, for their rheumatologic care.

“As we learn more and more,” she added, “we’ve come to understand that most treatments and medications are actually safe or relatively safe to take in pregnancy. Certainly, the benefit of taking them outweighs any small or theoretic risks. On the flip side, the guideline does a nice job of highlighting the importance of good disease control, both at the time of conception and during pregnancy.”
 

Contraception

In regard to contraception, the guideline strongly recommends the use of effective contraceptives – with a conditional recommendation of IUDs or a subdermal progestin implant – in fertile women with a RMD who have neither systemic lupus erythematosus (SLE) nor positive antiphospholipid antibody (aPL). They also strongly recommend discussing the use of emergency contraception with all RMD patients.

For SLE patients, the guideline strongly recommends the use of effective contraceptives in those with stable or low disease activity who are not positive for aPL. They also strongly recommend progestin‐only or IUD contraceptives over combined estrogen‐progestin contraception. For aPL-positive patients, the guideline strongly recommends against combined estrogen‐progestin contraceptives and for levonorgestrel or copper IUDs or the progestin‐only pill.
 

Assisted reproductive technology

In regard to ART, the guideline strongly recommends proceeding as needed in aPL-negative women with uncomplicated, stable RMD who are on pregnancy‐compatible medications. They also strongly recommend deferring ART in any RMD patients with moderately or severely active disease.

For aPL-positive patients undergoing ART procedures, they strongly recommend prophylactic anticoagulation with heparin or low-molecular-weight heparin (LMWH) in women with obstetric antiphospholipid syndrome (APS) and therapeutic anticoagulation in women with thrombotic APS. In patients undergoing embryo and oocyte cryopreservation, they strongly recommend continuing immunosuppressive and biologic therapies – the exception being cyclophosphamide (CYC) – for anyone in stable condition.
 

Fertility preservation

In regard to fertility preservation in patients taking CYC, the guideline strongly suggests sperm cryopreservation as good practice prior to treatment. They also conditionally recommend monthly gonadotropin‐releasing hormone agonist cotherapy in premenopausal women with RMD.

Hormone therapy

In regard to menopause and hormone therapy, the guideline strongly suggests hormone therapy as good practice in postmenopausal women with RMD, without SLE or positive aPL, and who have severe vasomotor symptoms. Hormone therapy is conditionally recommended in patients with SLE, without positive aPL, and with no contraindications. For aPL-positive patients, they strongly recommend against hormone therapy in women with obstetric and/or thrombotic APS.

Pregnancy assessment and management

Among the many recommendations regarding pregnancy assessment and management, the guideline strongly suggests counseling women with RMD who are considering pregnancy to take into account the improved outcomes for pregnant women with low disease activity. They strongly recommend that women considering pregnancy should switch to pregnancy‐compatible medication and pause to assess its efficacy and tolerability before moving forward, along with strongly recommending that pregnant women with active disease initiate or continue a pregnancy‐compatible steroid‐sparing medication. They also recommend testing for anti‐Ro/SS-A and anti‐La/SS-B in women with SLE, Sjögren’s syndrome, systemic sclerosis, or rheumatoid arthritis, but only once and only before or early in the pregnancy.

For women with systemic sclerosis who develop scleroderma renal crisis during pregnancy, the authors strongly advise using ACE inhibitors or angiotensin receptor blockers “because the risk of maternal or fetal death with untreated disease is higher than the risk associated with use of these medications during pregnancy.”

Among women with SLE, the recommendations strongly call for testing either before or early in pregnancy for anticardiolipin antibody, anti–beta2-glycoprotein I, or positive lupus anticoagulant, as well as initiating or continuing hydroxychloroquine (HCQ) if possible. Starting in the first trimester, the authors also conditionally recommend that SLE patients take low-dose aspirin daily

For pregnant women who test positive for aPL but do not meet criteria for obstetric or thrombotic APS, the guideline conditionally recommends prophylactic treatment with low-dose aspirin daily to protect against preeclampsia. When obstetric APS criteria are met, the guideline strongly advises combined treatment with daily low-dose aspirin and prophylactic-dose heparin (or LMWH), as well as prophylactic-dose anticoagulation for 6-12 weeks post partum. When patients have thrombotic APS, this combination treatment should contain heparin dose at a therapeutic level throughout pregnancy and postpartum. However, the authors conditionally recommend against giving low-dose aspirin plus prophylactic-dose heparin to women without obstetric APS. For refractory obstetric APS, the guideline also contains recommendations that are conditionally against treatment with intravenous immunoglobulin or an increased LMWH dose and strongly against adding prednisone to prophylactic-dose heparin or LMWH and low-dose aspirin. In pregnant patients with primary APS, the authors conditionally advise adding HCQ to prophylactic-dose heparin or LMWH and low-dose aspirin therapy. However, women with aPL who do not meet APS criteria or have another indication for HCQ are conditionally advised against prophylactic treatment with the antimalarial.

For women with Anti-Ro/SS-A and/or anti-La/SS-B antibodies in pregnancy, there is conditional advice to use HCQ. When there is no history of an infant with complete heart block or neonatal lupus erythematosus among women with these antibodies, the guideline conditionally advises serial fetal echocardiography (less often than weekly) starting between 16 and 18 weeks and continuing through 26 weeks, but this should be weekly when there is a prior history. Treatment with oral dexamethasone 4 mg daily is conditionally advised when there is echocardiographic evidence of fetal first- or second-degree heart block, but dexamethasone is not recommended when complete heart block is present.

Finally, in regard to medication use, the authors strongly recommend that men who are planning to be fathers continue on HCQ, azathioprine, 6‐mercaptopurine, colchicine, or tumor necrosis factor inhibitors. Conditional treatment recommendations for men planning for pregnancy include methotrexate, mycophenolate mofetil/mycophenolic acid (MMF), leflunomide, sulfasalazine, calcineurin inhibitors, and NSAIDs. They also strongly recommend that this group of men discontinue CYC and thalidomide.

Pregnant women are strongly recommended to discontinue methotrexate, leflunomide (with cholestyramine washout if there are detectable serum levels of its metabolite prior to pregnancy or as soon as it is confirmed), MMF, CYC, and thalidomide within 3 months prior to conception, and they strongly recommend HCQ (in women with SLE), azathioprine/6‐mercaptopurine, colchicine, or sulfasalazine for use throughout pregnancy. They strongly recommend a combination of low‐dose aspirin and prophylactic‐dose heparin for pregnant women with obstetric APS, along with low‐dose aspirin and therapeutic‐dose heparin for women with thrombotic APS throughout pregnancy and postpartum. However, for women with SLE and those who test positive for aPL but do not meet criteria for obstetric or thrombotic APS, the authors conditionally recommend low-dose aspirin starting in the first trimester.

The guideline suggests that women with RMD should be encouraged to breastfeed if they are willing and able; they also suggest that disease control be maintained through lactation‐compatible medications and that the risks and benefits be reviewed on a patient-by-patient basis. Treatment with HCQ, colchicine, sulfasalazine, rituximab, and all tumor necrosis factor inhibitors are strongly recommended as being compatible with breastfeeding, and they strongly recommend against using CYC, leflunomide, MMF, and thalidomide while breastfeeding.

The authors acknowledged the limitations of their guideline, including the literature review being conducted on studies involving adults and an “inability to include recommendations for uncommon but important clinical situations,” including those involving transgender patients and hormonal therapies.

The authors reported numerous potential conflicts of interest, including receiving research support, consulting fees, speaking fees, and honoraria from various pharmaceutical companies.

SOURCE: Sammaritano LR et al. Arthritis Rheumatol. 2020 Feb 23. doi: 10.1002/art.41191.

GRAPEVINE, TEX. – Early postpartum glucose tolerance testing for women with gestational diabetes resulted in a 99% adherence rate, with similar sensitivity and specificity as the currently recommended 4- to 12-week postpartum testing schedule.

“Two-day postpartum glucose tolerance testing has similar diagnostic utility as the 4- to 12-week postpartum glucose tolerance test to identify impaired glucose metabolism and diabetes at 1 year postpartum,” said Erika Werner, MD, speaking at the meeting sponsored by the Society for Maternal-Fetal Medicine.

Overall, 29% of women studied had impaired glucose metabolism at 2 days postpartum, as did 25% in the 4- to 12-weeks postpartum window. At 1 year, that figure was 35%. The number of women meeting diagnostic criteria for diabetes held steady at 4% for all three time points.

The findings warrant “consideration for the 2-day postpartum glucose tolerance test (GTT) as the initial postpartum test for women who have gestational diabetes, with repeat testing at 1 year,” said Dr. Werner, a maternal-fetal medicine physician at Brown University, Providence, R.I.

Glucose testing for women with gestational diabetes mellitus (GDM) is recommended at 4-12 weeks postpartum by both the American Diabetes Association and the American College of Obstetricians and Gynecologists.

Testing can allow detection and treatment of impaired glucose metabolism, seen in 15%-40% of women with a history of GDM. Up to 1 in 20 women with GDM will receive a postpartum diagnosis of type 2 diabetes.

However, fewer than one in five women will actually have postpartum glucose testing, representing a large missed opportunity, said Dr. Werner.

Several factors likely contribute to those screening failures, she added. In addition to the potential for public insurance to lapse at 6 weeks postpartum, the logistical realities and time demands of parenting a newborn are themselves a significant barrier.

“What if we changed the timing?” and shifted glucose testing to the early postpartum days, before hospital discharge, asked Dr. Werner. Several pilot studies had already compared glucose screening in the first few days postpartum with the routine schedule, finding good correlation between the early and routine GTT schedule.

Importantly, the earlier studies achieved an adherence rate of more than 90% for early GTT. By contrast, fewer than half of the participants in the usual-care arms actually returned for postpartum GTT in the 4- to 12-week postpartum window, even under the optimized conditions associated with a medical study.

The single-center prospective cohort study conducted by Dr. Werner and collaborators enrolled 300 women with GDM. Women agreed to participate in glucose tolerance testing as inpatients, at 2 days postpartum, in addition to receiving a GTT between 4 and 12 weeks postpartum, and additional screening that included a glycosylated hemoglobin (HbA_1c) test at 1 year postpartum.

The investigators obtained postpartum day 2 GTTs for all but four of the patients. A total of 201 patients returned in the 4- to 12-week postpartum window, and 168 of those participants returned for HbA1c testing at 1 year. Of the 95 patients who didn’t come back for the 4- to 12-week test, 33 did return at 1 year for HbA_1c testing.

Dr. Werner and her coinvestigators included adult women who spoke either fluent Spanish or English and had GDM diagnosed by the Carpenter-Coustan criteria, or by having a blood glucose level of 200 mg/dL or more in a 1-hour glucose challenge test.

The early GTT results weren’t shared with patients or their health care providers. For outpatient visits, participants were offered financial incentives and received multiple reminder phone calls and the offer of free transportation.

For the purposes of the study, impaired glucose metabolism was defined as fasting blood glucose of 100 mg/dL or greater, a 2-hour GTT blood glucose level of 140 mg/dL or greater, or HbA_1c of 5.7% or greater.

Participants were diagnosed with diabetes if they had a fasting blood glucose of 126 mg/dL or greater, a 2-hour GTT blood glucose level of 200 mg/dL or greater, or HbA_1c of 6.5% or greater.

Dr. Werner and colleagues conducted two analyses of their results. In the first, they included only women in both arms who had complete data. In the second analysis, they looked at all women who had data for the 1-year postpartum mark, assuming that interval GTTs were negative for women who were missing these values.

The statistical analysis showed that, for women with complete data, both early and later postpartum GTTs were similar in predicting impaired glucose metabolism at 1 year postpartum (areas under the receiver operating curve [AUC], 0.63 and 0.60, respectively).

For identifying diabetes at 1 year, both early and late testing had high negative predictive value (98% and 99%, respectively), but the later testing strategy had higher sensitivity and specificity, yielding an AUC of 0.83, compared with 0.65 for early testing.

Turning to the second analysis that included all women who had 1-year postpartum HbA_1c values, negative predictive values for diabetes were similarly high (98%) for both the early and late testing strategies. For identifying impaired glucose metabolism at 1 year in this group, both the positive and negative predictive value of the early and late strategies were similar.

Patients were about 32 years old at baseline, with a mean body mass index of 31.7 kg/m². More than half of patients (52.3%) had private insurance, and 22% had GDM in a pregnancy prior to the index pregnancy. Black patients made up about 9% of the study population; 54% of participants were white, and 23% Hispanic. About one-third of patients were nulliparous, and two-thirds had education beyond high school.

During their pregnancies, about 44% of patients managed GDM by diet alone, 40% required insulin, with an additional 1% also requiring an oral agent. The remainder required oral agents alone. Patients delivered at a mean 38.3 weeks gestation, with about 40% receiving cesarean deliveries.

Some of the study’s strengths included its prospective nature, the diverse population recruited, and the fact that participants and providers were both blinded to the 2-day GTT results. Although more than half of participants completed the study – besting the previous pilots – 44% of patients still had incomplete data, noted Dr. Werner.

The American Diabetes Association sponsored the study. Dr. Werner reported no other conflicts of interest.

[email protected]

SOURCE: Werner E et al. SMFM 2020. Abstract 72.

GRAPEVINE, TEX. – Early postpartum glucose tolerance testing for women with gestational diabetes resulted in a 99% adherence rate, with similar sensitivity and specificity as the currently recommended 4- to 12-week postpartum testing schedule.

“Two-day postpartum glucose tolerance testing has similar diagnostic utility as the 4- to 12-week postpartum glucose tolerance test to identify impaired glucose metabolism and diabetes at 1 year postpartum,” said Erika Werner, MD, speaking at the meeting sponsored by the Society for Maternal-Fetal Medicine.

Overall, 29% of women studied had impaired glucose metabolism at 2 days postpartum, as did 25% in the 4- to 12-weeks postpartum window. At 1 year, that figure was 35%. The number of women meeting diagnostic criteria for diabetes held steady at 4% for all three time points.

The findings warrant “consideration for the 2-day postpartum glucose tolerance test (GTT) as the initial postpartum test for women who have gestational diabetes, with repeat testing at 1 year,” said Dr. Werner, a maternal-fetal medicine physician at Brown University, Providence, R.I.

Glucose testing for women with gestational diabetes mellitus (GDM) is recommended at 4-12 weeks postpartum by both the American Diabetes Association and the American College of Obstetricians and Gynecologists.

Testing can allow detection and treatment of impaired glucose metabolism, seen in 15%-40% of women with a history of GDM. Up to 1 in 20 women with GDM will receive a postpartum diagnosis of type 2 diabetes.

However, fewer than one in five women will actually have postpartum glucose testing, representing a large missed opportunity, said Dr. Werner.

Several factors likely contribute to those screening failures, she added. In addition to the potential for public insurance to lapse at 6 weeks postpartum, the logistical realities and time demands of parenting a newborn are themselves a significant barrier.

“What if we changed the timing?” and shifted glucose testing to the early postpartum days, before hospital discharge, asked Dr. Werner. Several pilot studies had already compared glucose screening in the first few days postpartum with the routine schedule, finding good correlation between the early and routine GTT schedule.

Importantly, the earlier studies achieved an adherence rate of more than 90% for early GTT. By contrast, fewer than half of the participants in the usual-care arms actually returned for postpartum GTT in the 4- to 12-week postpartum window, even under the optimized conditions associated with a medical study.

The single-center prospective cohort study conducted by Dr. Werner and collaborators enrolled 300 women with GDM. Women agreed to participate in glucose tolerance testing as inpatients, at 2 days postpartum, in addition to receiving a GTT between 4 and 12 weeks postpartum, and additional screening that included a glycosylated hemoglobin (HbA_1c) test at 1 year postpartum.

The investigators obtained postpartum day 2 GTTs for all but four of the patients. A total of 201 patients returned in the 4- to 12-week postpartum window, and 168 of those participants returned for HbA1c testing at 1 year. Of the 95 patients who didn’t come back for the 4- to 12-week test, 33 did return at 1 year for HbA_1c testing.

Dr. Werner and her coinvestigators included adult women who spoke either fluent Spanish or English and had GDM diagnosed by the Carpenter-Coustan criteria, or by having a blood glucose level of 200 mg/dL or more in a 1-hour glucose challenge test.

The early GTT results weren’t shared with patients or their health care providers. For outpatient visits, participants were offered financial incentives and received multiple reminder phone calls and the offer of free transportation.

For the purposes of the study, impaired glucose metabolism was defined as fasting blood glucose of 100 mg/dL or greater, a 2-hour GTT blood glucose level of 140 mg/dL or greater, or HbA_1c of 5.7% or greater.

Participants were diagnosed with diabetes if they had a fasting blood glucose of 126 mg/dL or greater, a 2-hour GTT blood glucose level of 200 mg/dL or greater, or HbA_1c of 6.5% or greater.

Dr. Werner and colleagues conducted two analyses of their results. In the first, they included only women in both arms who had complete data. In the second analysis, they looked at all women who had data for the 1-year postpartum mark, assuming that interval GTTs were negative for women who were missing these values.

The statistical analysis showed that, for women with complete data, both early and later postpartum GTTs were similar in predicting impaired glucose metabolism at 1 year postpartum (areas under the receiver operating curve [AUC], 0.63 and 0.60, respectively).

For identifying diabetes at 1 year, both early and late testing had high negative predictive value (98% and 99%, respectively), but the later testing strategy had higher sensitivity and specificity, yielding an AUC of 0.83, compared with 0.65 for early testing.

Turning to the second analysis that included all women who had 1-year postpartum HbA_1c values, negative predictive values for diabetes were similarly high (98%) for both the early and late testing strategies. For identifying impaired glucose metabolism at 1 year in this group, both the positive and negative predictive value of the early and late strategies were similar.

Patients were about 32 years old at baseline, with a mean body mass index of 31.7 kg/m². More than half of patients (52.3%) had private insurance, and 22% had GDM in a pregnancy prior to the index pregnancy. Black patients made up about 9% of the study population; 54% of participants were white, and 23% Hispanic. About one-third of patients were nulliparous, and two-thirds had education beyond high school.

During their pregnancies, about 44% of patients managed GDM by diet alone, 40% required insulin, with an additional 1% also requiring an oral agent. The remainder required oral agents alone. Patients delivered at a mean 38.3 weeks gestation, with about 40% receiving cesarean deliveries.

Some of the study’s strengths included its prospective nature, the diverse population recruited, and the fact that participants and providers were both blinded to the 2-day GTT results. Although more than half of participants completed the study – besting the previous pilots – 44% of patients still had incomplete data, noted Dr. Werner.

The American Diabetes Association sponsored the study. Dr. Werner reported no other conflicts of interest.

[email protected]

SOURCE: Werner E et al. SMFM 2020. Abstract 72.

GRAPEVINE, TEX. – Early postpartum glucose tolerance testing for women with gestational diabetes resulted in a 99% adherence rate, with similar sensitivity and specificity as the currently recommended 4- to 12-week postpartum testing schedule.

“Two-day postpartum glucose tolerance testing has similar diagnostic utility as the 4- to 12-week postpartum glucose tolerance test to identify impaired glucose metabolism and diabetes at 1 year postpartum,” said Erika Werner, MD, speaking at the meeting sponsored by the Society for Maternal-Fetal Medicine.

Overall, 29% of women studied had impaired glucose metabolism at 2 days postpartum, as did 25% in the 4- to 12-weeks postpartum window. At 1 year, that figure was 35%. The number of women meeting diagnostic criteria for diabetes held steady at 4% for all three time points.

The findings warrant “consideration for the 2-day postpartum glucose tolerance test (GTT) as the initial postpartum test for women who have gestational diabetes, with repeat testing at 1 year,” said Dr. Werner, a maternal-fetal medicine physician at Brown University, Providence, R.I.

Glucose testing for women with gestational diabetes mellitus (GDM) is recommended at 4-12 weeks postpartum by both the American Diabetes Association and the American College of Obstetricians and Gynecologists.

Testing can allow detection and treatment of impaired glucose metabolism, seen in 15%-40% of women with a history of GDM. Up to 1 in 20 women with GDM will receive a postpartum diagnosis of type 2 diabetes.

However, fewer than one in five women will actually have postpartum glucose testing, representing a large missed opportunity, said Dr. Werner.

Several factors likely contribute to those screening failures, she added. In addition to the potential for public insurance to lapse at 6 weeks postpartum, the logistical realities and time demands of parenting a newborn are themselves a significant barrier.

“What if we changed the timing?” and shifted glucose testing to the early postpartum days, before hospital discharge, asked Dr. Werner. Several pilot studies had already compared glucose screening in the first few days postpartum with the routine schedule, finding good correlation between the early and routine GTT schedule.

Importantly, the earlier studies achieved an adherence rate of more than 90% for early GTT. By contrast, fewer than half of the participants in the usual-care arms actually returned for postpartum GTT in the 4- to 12-week postpartum window, even under the optimized conditions associated with a medical study.

The single-center prospective cohort study conducted by Dr. Werner and collaborators enrolled 300 women with GDM. Women agreed to participate in glucose tolerance testing as inpatients, at 2 days postpartum, in addition to receiving a GTT between 4 and 12 weeks postpartum, and additional screening that included a glycosylated hemoglobin (HbA_1c) test at 1 year postpartum.

The investigators obtained postpartum day 2 GTTs for all but four of the patients. A total of 201 patients returned in the 4- to 12-week postpartum window, and 168 of those participants returned for HbA1c testing at 1 year. Of the 95 patients who didn’t come back for the 4- to 12-week test, 33 did return at 1 year for HbA_1c testing.

Dr. Werner and her coinvestigators included adult women who spoke either fluent Spanish or English and had GDM diagnosed by the Carpenter-Coustan criteria, or by having a blood glucose level of 200 mg/dL or more in a 1-hour glucose challenge test.

The early GTT results weren’t shared with patients or their health care providers. For outpatient visits, participants were offered financial incentives and received multiple reminder phone calls and the offer of free transportation.

For the purposes of the study, impaired glucose metabolism was defined as fasting blood glucose of 100 mg/dL or greater, a 2-hour GTT blood glucose level of 140 mg/dL or greater, or HbA_1c of 5.7% or greater.

Participants were diagnosed with diabetes if they had a fasting blood glucose of 126 mg/dL or greater, a 2-hour GTT blood glucose level of 200 mg/dL or greater, or HbA_1c of 6.5% or greater.

Dr. Werner and colleagues conducted two analyses of their results. In the first, they included only women in both arms who had complete data. In the second analysis, they looked at all women who had data for the 1-year postpartum mark, assuming that interval GTTs were negative for women who were missing these values.

The statistical analysis showed that, for women with complete data, both early and later postpartum GTTs were similar in predicting impaired glucose metabolism at 1 year postpartum (areas under the receiver operating curve [AUC], 0.63 and 0.60, respectively).

For identifying diabetes at 1 year, both early and late testing had high negative predictive value (98% and 99%, respectively), but the later testing strategy had higher sensitivity and specificity, yielding an AUC of 0.83, compared with 0.65 for early testing.

Turning to the second analysis that included all women who had 1-year postpartum HbA_1c values, negative predictive values for diabetes were similarly high (98%) for both the early and late testing strategies. For identifying impaired glucose metabolism at 1 year in this group, both the positive and negative predictive value of the early and late strategies were similar.

Patients were about 32 years old at baseline, with a mean body mass index of 31.7 kg/m². More than half of patients (52.3%) had private insurance, and 22% had GDM in a pregnancy prior to the index pregnancy. Black patients made up about 9% of the study population; 54% of participants were white, and 23% Hispanic. About one-third of patients were nulliparous, and two-thirds had education beyond high school.

During their pregnancies, about 44% of patients managed GDM by diet alone, 40% required insulin, with an additional 1% also requiring an oral agent. The remainder required oral agents alone. Patients delivered at a mean 38.3 weeks gestation, with about 40% receiving cesarean deliveries.

Some of the study’s strengths included its prospective nature, the diverse population recruited, and the fact that participants and providers were both blinded to the 2-day GTT results. Although more than half of participants completed the study – besting the previous pilots – 44% of patients still had incomplete data, noted Dr. Werner.

The American Diabetes Association sponsored the study. Dr. Werner reported no other conflicts of interest.

[email protected]

SOURCE: Werner E et al. SMFM 2020. Abstract 72.