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Consider thalassemia traits in patients with iron deficiency
Consider thalassemia traits in patients with iron deficiency
The editorial is an excellent review of iron deficiency as an associated finding with adverse health and pregnancy outcomes. However, one genetic issue appears to have escaped comment. In Florida, our African American patients hav
Your recommendation to routinely screen for ferritin deficit is laudable as a general health care practice. If the screening result is normal, however, consider thalassemia carrier states as a secondary explanation as well as a genetic issue requiring partner testing. Aggressive iron loading of a nondeficient anemic patient can risk excess absorption, storage, and ultimate organ compromise in later life if continued indefinitely.
Richard P. Perkins, MD
Fort Myers, Florida
Patient education is key to managing iron deficiency
Forty years ago, my professors expounded on how some people could not absorb iron and that the answer was intravenous iron infusion. After writing a few prescriptions, however, I found that I no longer had patients with absorptive problems once I learned to carefully, and with visual aids, explain the iron story and meticulously monitor compliance. I have been through the “slow Fe” and the “prenatal vitamins have iron” nonsense. Ferrous sulfate is about as good as anything. I have explained the theory of vitamin C−assist and found that telling people to avoid taking iron with meals is folly.
I suggest that the iron story is complete. Rather than wasting money on further research, we should spend funds on teaching young physicians to educate patients and monitor compliance. In recent years, I have found that a daily text message to the patient frequently is very helpful.
Robert W. Jackson, MD
Washougal, Washington
Dr. Barbieri responds
I thank Drs. Perkins and Jackson for their helpful recommendations for the management of iron deficiency anemia. I agree with Dr. Perkins that screening for thalassemia is an important part of preconception and prenatal care. In the editorial’s table on page 10 discussing the differential diagnosis of anemia, we mentioned the importance of hemoglobin electrophoresis and measurement of vitamin B12 and folate levels to identify cases of anemia caused by thalassemia or vitamin deficiency. I agree with Dr. Jackson that oral iron supplementation along with patient education can resolve most cases of iron deficiency in early and mid-pregnancy. However, in the last few weeks of pregnancy there may not be sufficient time for oral iron supplementation to be effective in resolving iron deficiency anemia. In this situation and in patients at high risk for malabsorption, including women with prior gastric bypass, intravenous iron might be the best approach to resolving the anemia.
Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.
Consider thalassemia traits in patients with iron deficiency
The editorial is an excellent review of iron deficiency as an associated finding with adverse health and pregnancy outcomes. However, one genetic issue appears to have escaped comment. In Florida, our African American patients hav
Your recommendation to routinely screen for ferritin deficit is laudable as a general health care practice. If the screening result is normal, however, consider thalassemia carrier states as a secondary explanation as well as a genetic issue requiring partner testing. Aggressive iron loading of a nondeficient anemic patient can risk excess absorption, storage, and ultimate organ compromise in later life if continued indefinitely.
Richard P. Perkins, MD
Fort Myers, Florida
Patient education is key to managing iron deficiency
Forty years ago, my professors expounded on how some people could not absorb iron and that the answer was intravenous iron infusion. After writing a few prescriptions, however, I found that I no longer had patients with absorptive problems once I learned to carefully, and with visual aids, explain the iron story and meticulously monitor compliance. I have been through the “slow Fe” and the “prenatal vitamins have iron” nonsense. Ferrous sulfate is about as good as anything. I have explained the theory of vitamin C−assist and found that telling people to avoid taking iron with meals is folly.
I suggest that the iron story is complete. Rather than wasting money on further research, we should spend funds on teaching young physicians to educate patients and monitor compliance. In recent years, I have found that a daily text message to the patient frequently is very helpful.
Robert W. Jackson, MD
Washougal, Washington
Dr. Barbieri responds
I thank Drs. Perkins and Jackson for their helpful recommendations for the management of iron deficiency anemia. I agree with Dr. Perkins that screening for thalassemia is an important part of preconception and prenatal care. In the editorial’s table on page 10 discussing the differential diagnosis of anemia, we mentioned the importance of hemoglobin electrophoresis and measurement of vitamin B12 and folate levels to identify cases of anemia caused by thalassemia or vitamin deficiency. I agree with Dr. Jackson that oral iron supplementation along with patient education can resolve most cases of iron deficiency in early and mid-pregnancy. However, in the last few weeks of pregnancy there may not be sufficient time for oral iron supplementation to be effective in resolving iron deficiency anemia. In this situation and in patients at high risk for malabsorption, including women with prior gastric bypass, intravenous iron might be the best approach to resolving the anemia.
Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.
Consider thalassemia traits in patients with iron deficiency
The editorial is an excellent review of iron deficiency as an associated finding with adverse health and pregnancy outcomes. However, one genetic issue appears to have escaped comment. In Florida, our African American patients hav
Your recommendation to routinely screen for ferritin deficit is laudable as a general health care practice. If the screening result is normal, however, consider thalassemia carrier states as a secondary explanation as well as a genetic issue requiring partner testing. Aggressive iron loading of a nondeficient anemic patient can risk excess absorption, storage, and ultimate organ compromise in later life if continued indefinitely.
Richard P. Perkins, MD
Fort Myers, Florida
Patient education is key to managing iron deficiency
Forty years ago, my professors expounded on how some people could not absorb iron and that the answer was intravenous iron infusion. After writing a few prescriptions, however, I found that I no longer had patients with absorptive problems once I learned to carefully, and with visual aids, explain the iron story and meticulously monitor compliance. I have been through the “slow Fe” and the “prenatal vitamins have iron” nonsense. Ferrous sulfate is about as good as anything. I have explained the theory of vitamin C−assist and found that telling people to avoid taking iron with meals is folly.
I suggest that the iron story is complete. Rather than wasting money on further research, we should spend funds on teaching young physicians to educate patients and monitor compliance. In recent years, I have found that a daily text message to the patient frequently is very helpful.
Robert W. Jackson, MD
Washougal, Washington
Dr. Barbieri responds
I thank Drs. Perkins and Jackson for their helpful recommendations for the management of iron deficiency anemia. I agree with Dr. Perkins that screening for thalassemia is an important part of preconception and prenatal care. In the editorial’s table on page 10 discussing the differential diagnosis of anemia, we mentioned the importance of hemoglobin electrophoresis and measurement of vitamin B12 and folate levels to identify cases of anemia caused by thalassemia or vitamin deficiency. I agree with Dr. Jackson that oral iron supplementation along with patient education can resolve most cases of iron deficiency in early and mid-pregnancy. However, in the last few weeks of pregnancy there may not be sufficient time for oral iron supplementation to be effective in resolving iron deficiency anemia. In this situation and in patients at high risk for malabsorption, including women with prior gastric bypass, intravenous iron might be the best approach to resolving the anemia.
Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.
HCV infection tied to premature ovarian senescence and a high miscarriage rate
Premenopausal women with hepatitis C virus (HCV) showed increased ovarian senescence, which was associated with a lower chance of live birth. Such women also had a greater risk of infertility, as reported in the Journal of Hepatology.
Researchers examined three cohort studies, which comprised an age-matched prospectively enrolled cohort study of 100 women who were HCV positive and had chronic liver disease, 50 women who were HBV positive and had CLD, and 100 healthy women; 1,998 HCV-infected women enrolled in the Platform for the Study of Viral Hepatitis Therapies (PITER) trial from Italy; and 6,085 women infected with HCV plus 20,415 uninfected women from a United States database, according to Aimilia Karampatou, MD, of the University of Bologna, Modena, Italy, and colleagues.
In the second group examined, the women from the PITER trial, miscarriages occurred in 42% of the HCV-infected women with 44.6% of these women experiencing multiple miscarriages. The total fertility rate, defined as the average number of children that would be born in a lifetime, was 0.7 for the HCV-infected women, compared with 1.37 in the general Italian population.
Infertility data from the large U.S. study was assessed from a total of 27,525 women (20,415 HCV negative and HIV negative; 6,805 HCV positive; and 305 HCV positive/HIV positive). Women with HCV showed a significantly higher probability of infertility compared with uninfected controls (odds ratio, 2.44), and those women dually infected with HCV and HIV were affected even more (OR, 3.64).
Primarily based on the observations of AMH, which in many of the HCV-positive women fell into the menopausal range, the researchers suggested that “the reduced reproductive capacity of women who are HCV positive is related to failing ovarian function and subsequent follicular depletion in the context of a more generalized dysfunction of other fertility-related factors.”
With regard to the effect of antiviral therapy, AMH levels remained stable in women who attained a sustained virologic response but continued to fall in those for whom the therapy was a failure.
“HCV infection significantly and negatively affects many aspects of fertility. It remains to be assessed whether antiviral therapy at a very early age can positively influence the occurrence of miscarriages and can prevent ovarian senescence because the latter has broader health implications than simply preserving fertility,” the researchers concluded.
The authors reported that they had no conflicts of interest.
SOURCE: Karampatou A et al. J Hepatology. 2018;68:33-41.
Premenopausal women with hepatitis C virus (HCV) showed increased ovarian senescence, which was associated with a lower chance of live birth. Such women also had a greater risk of infertility, as reported in the Journal of Hepatology.
Researchers examined three cohort studies, which comprised an age-matched prospectively enrolled cohort study of 100 women who were HCV positive and had chronic liver disease, 50 women who were HBV positive and had CLD, and 100 healthy women; 1,998 HCV-infected women enrolled in the Platform for the Study of Viral Hepatitis Therapies (PITER) trial from Italy; and 6,085 women infected with HCV plus 20,415 uninfected women from a United States database, according to Aimilia Karampatou, MD, of the University of Bologna, Modena, Italy, and colleagues.
In the second group examined, the women from the PITER trial, miscarriages occurred in 42% of the HCV-infected women with 44.6% of these women experiencing multiple miscarriages. The total fertility rate, defined as the average number of children that would be born in a lifetime, was 0.7 for the HCV-infected women, compared with 1.37 in the general Italian population.
Infertility data from the large U.S. study was assessed from a total of 27,525 women (20,415 HCV negative and HIV negative; 6,805 HCV positive; and 305 HCV positive/HIV positive). Women with HCV showed a significantly higher probability of infertility compared with uninfected controls (odds ratio, 2.44), and those women dually infected with HCV and HIV were affected even more (OR, 3.64).
Primarily based on the observations of AMH, which in many of the HCV-positive women fell into the menopausal range, the researchers suggested that “the reduced reproductive capacity of women who are HCV positive is related to failing ovarian function and subsequent follicular depletion in the context of a more generalized dysfunction of other fertility-related factors.”
With regard to the effect of antiviral therapy, AMH levels remained stable in women who attained a sustained virologic response but continued to fall in those for whom the therapy was a failure.
“HCV infection significantly and negatively affects many aspects of fertility. It remains to be assessed whether antiviral therapy at a very early age can positively influence the occurrence of miscarriages and can prevent ovarian senescence because the latter has broader health implications than simply preserving fertility,” the researchers concluded.
The authors reported that they had no conflicts of interest.
SOURCE: Karampatou A et al. J Hepatology. 2018;68:33-41.
Premenopausal women with hepatitis C virus (HCV) showed increased ovarian senescence, which was associated with a lower chance of live birth. Such women also had a greater risk of infertility, as reported in the Journal of Hepatology.
Researchers examined three cohort studies, which comprised an age-matched prospectively enrolled cohort study of 100 women who were HCV positive and had chronic liver disease, 50 women who were HBV positive and had CLD, and 100 healthy women; 1,998 HCV-infected women enrolled in the Platform for the Study of Viral Hepatitis Therapies (PITER) trial from Italy; and 6,085 women infected with HCV plus 20,415 uninfected women from a United States database, according to Aimilia Karampatou, MD, of the University of Bologna, Modena, Italy, and colleagues.
In the second group examined, the women from the PITER trial, miscarriages occurred in 42% of the HCV-infected women with 44.6% of these women experiencing multiple miscarriages. The total fertility rate, defined as the average number of children that would be born in a lifetime, was 0.7 for the HCV-infected women, compared with 1.37 in the general Italian population.
Infertility data from the large U.S. study was assessed from a total of 27,525 women (20,415 HCV negative and HIV negative; 6,805 HCV positive; and 305 HCV positive/HIV positive). Women with HCV showed a significantly higher probability of infertility compared with uninfected controls (odds ratio, 2.44), and those women dually infected with HCV and HIV were affected even more (OR, 3.64).
Primarily based on the observations of AMH, which in many of the HCV-positive women fell into the menopausal range, the researchers suggested that “the reduced reproductive capacity of women who are HCV positive is related to failing ovarian function and subsequent follicular depletion in the context of a more generalized dysfunction of other fertility-related factors.”
With regard to the effect of antiviral therapy, AMH levels remained stable in women who attained a sustained virologic response but continued to fall in those for whom the therapy was a failure.
“HCV infection significantly and negatively affects many aspects of fertility. It remains to be assessed whether antiviral therapy at a very early age can positively influence the occurrence of miscarriages and can prevent ovarian senescence because the latter has broader health implications than simply preserving fertility,” the researchers concluded.
The authors reported that they had no conflicts of interest.
SOURCE: Karampatou A et al. J Hepatology. 2018;68:33-41.
FROM THE JOURNAL OF HEPATOLOGY
Key clinical point: HCV-positive women appear to undergo increased ovarian senescence.
Major finding: The fertility rate of HCV-positive women was 0.7 vs. 1.37 in the general population.
Study details: Three separate studies together comprising more than 30,000 HCV-infected and -uninfected women.
Disclosures: The authors reported that they had no conflicts of interest.
Source: Karampatou A et al. J Hepatology. 2018;68:33-41.
Maternal hypertension QI initiative cuts severe morbidity by 41%
DALLAS – A statewide quality improvement initiative to address treatment strategies for women with severe maternal hypertension resulted in a 41% reduction in severe maternal morbidity, from 15% before the initiative to 9% after the suite of interventions was fully implemented.
A total of 102 Illinois hospitals participated in the quality improvement (QI) initiative, which eventually included 12,718 women with severe maternal hypertension, defined as blood pressure greater than 160/110 mm Hg.
The number of patients who were scheduled for follow-up appointments within 10 days of discharge increased from 53% to 83% after the QI initiative was implemented. The proportion of cases of severe maternal hypertension that were subject to a provider-nurse debrief analyzing time to treatment went from 2% before the intervention to 53%.
Dr. Lee King presented the findings to a receptive audience at a plenary session of the meeting sponsored by the Society for Maternal-Fetal Medicine. “We had a philosophy of ‘leave no hospital behind,’ and of ‘leave no patient behind,’ ” she said, to wide applause.
“The key prevention of maternal morbidity and mortality associated with severe maternal hypertension is timely treatment; the primary cause of maternal death associated with hypertensive disorders of pregnancy is maternal hemorrhagic stroke,” said Dr. Lee King.
The multidisciplinary, multistakeholder project was coordinated by the Illinois Perinatal Quality Collaborative (ILPQC), housed at Northwestern University, Chicago. The participating hospitals account for over 95% of the births in the state of Illinois, said Dr. Lee King, ILPQC state project director.
The approach used for implementation of the hypertension QI initiative included collaborative learning and the use of rapid response data to give near–real time feedback on how institutions were faring in meeting national guidelines to treat severe maternal hypertension.
Specific clinical interventions included both “system changes and culture changes,” said Dr. Lee King. They included adopting facility-wide protocols for timely identification and treatment of women with severe maternal hypertension; standardizing patient education and discharge planning; increasing provider and nurse education about severe maternal hypertension protocols; and creating rapid access to medication and standardized treatment order sets.
The ILPQC facilitated collaboration between hospitals in meeting these aims, including monthly web-based updates and seminars and construction of the database that gave institutions rapid access to data for ongoing QI efforts. Newsletters, website updates, and QI support were also part of the ILPQC package.
The proportion of participating hospitals meeting time-to-treatment goals for severe maternal hypertension went from 13% at baseline to 71% at the end of data collection, said Dr. Lee King.
In looking at hospital characteristics such as rurality, size, and patient mix, Dr. Lee King and her collaborators found no significant differences in time to treatment, patient education, and number of cases that were debriefed.
“These strategies helped hospitals achieve initiative goals, regardless of hospital characteristics,” said Dr. Lee King. The only significant association the research team found was that hospitals with fewer than 500 deliveries per year were less likely to reach the goal of early follow-up appointments (P less than .02).
“Participation in a statewide perinatal quality collaborative increases hospitals’ QI capacity. A statewide QI initiative can achieve significant population-level improvements in care for women with severe maternal hypertension and – more importantly – a reduction in severe maternal morbidity,” Dr. Lee King said.
The QI initiative and the follow-up study were conducted by the Illinois Perinatal Quality Collaborative, and the work was funded by the Centers for Disease Control and Prevention, the Illinois Department of Health, and the Alliance for Intervention on Maternal Health. Materials related to the maternal hypertension initiative are available at http://ilpqc.org/?q=Hypertension. Dr. Lee King reported no conflicts of interest.
SOURCE: Lee King P et al. Am J Obstet Gynecol. 2018 Jan;218:S4.
DALLAS – A statewide quality improvement initiative to address treatment strategies for women with severe maternal hypertension resulted in a 41% reduction in severe maternal morbidity, from 15% before the initiative to 9% after the suite of interventions was fully implemented.
A total of 102 Illinois hospitals participated in the quality improvement (QI) initiative, which eventually included 12,718 women with severe maternal hypertension, defined as blood pressure greater than 160/110 mm Hg.
The number of patients who were scheduled for follow-up appointments within 10 days of discharge increased from 53% to 83% after the QI initiative was implemented. The proportion of cases of severe maternal hypertension that were subject to a provider-nurse debrief analyzing time to treatment went from 2% before the intervention to 53%.
Dr. Lee King presented the findings to a receptive audience at a plenary session of the meeting sponsored by the Society for Maternal-Fetal Medicine. “We had a philosophy of ‘leave no hospital behind,’ and of ‘leave no patient behind,’ ” she said, to wide applause.
“The key prevention of maternal morbidity and mortality associated with severe maternal hypertension is timely treatment; the primary cause of maternal death associated with hypertensive disorders of pregnancy is maternal hemorrhagic stroke,” said Dr. Lee King.
The multidisciplinary, multistakeholder project was coordinated by the Illinois Perinatal Quality Collaborative (ILPQC), housed at Northwestern University, Chicago. The participating hospitals account for over 95% of the births in the state of Illinois, said Dr. Lee King, ILPQC state project director.
The approach used for implementation of the hypertension QI initiative included collaborative learning and the use of rapid response data to give near–real time feedback on how institutions were faring in meeting national guidelines to treat severe maternal hypertension.
Specific clinical interventions included both “system changes and culture changes,” said Dr. Lee King. They included adopting facility-wide protocols for timely identification and treatment of women with severe maternal hypertension; standardizing patient education and discharge planning; increasing provider and nurse education about severe maternal hypertension protocols; and creating rapid access to medication and standardized treatment order sets.
The ILPQC facilitated collaboration between hospitals in meeting these aims, including monthly web-based updates and seminars and construction of the database that gave institutions rapid access to data for ongoing QI efforts. Newsletters, website updates, and QI support were also part of the ILPQC package.
The proportion of participating hospitals meeting time-to-treatment goals for severe maternal hypertension went from 13% at baseline to 71% at the end of data collection, said Dr. Lee King.
In looking at hospital characteristics such as rurality, size, and patient mix, Dr. Lee King and her collaborators found no significant differences in time to treatment, patient education, and number of cases that were debriefed.
“These strategies helped hospitals achieve initiative goals, regardless of hospital characteristics,” said Dr. Lee King. The only significant association the research team found was that hospitals with fewer than 500 deliveries per year were less likely to reach the goal of early follow-up appointments (P less than .02).
“Participation in a statewide perinatal quality collaborative increases hospitals’ QI capacity. A statewide QI initiative can achieve significant population-level improvements in care for women with severe maternal hypertension and – more importantly – a reduction in severe maternal morbidity,” Dr. Lee King said.
The QI initiative and the follow-up study were conducted by the Illinois Perinatal Quality Collaborative, and the work was funded by the Centers for Disease Control and Prevention, the Illinois Department of Health, and the Alliance for Intervention on Maternal Health. Materials related to the maternal hypertension initiative are available at http://ilpqc.org/?q=Hypertension. Dr. Lee King reported no conflicts of interest.
SOURCE: Lee King P et al. Am J Obstet Gynecol. 2018 Jan;218:S4.
DALLAS – A statewide quality improvement initiative to address treatment strategies for women with severe maternal hypertension resulted in a 41% reduction in severe maternal morbidity, from 15% before the initiative to 9% after the suite of interventions was fully implemented.
A total of 102 Illinois hospitals participated in the quality improvement (QI) initiative, which eventually included 12,718 women with severe maternal hypertension, defined as blood pressure greater than 160/110 mm Hg.
The number of patients who were scheduled for follow-up appointments within 10 days of discharge increased from 53% to 83% after the QI initiative was implemented. The proportion of cases of severe maternal hypertension that were subject to a provider-nurse debrief analyzing time to treatment went from 2% before the intervention to 53%.
Dr. Lee King presented the findings to a receptive audience at a plenary session of the meeting sponsored by the Society for Maternal-Fetal Medicine. “We had a philosophy of ‘leave no hospital behind,’ and of ‘leave no patient behind,’ ” she said, to wide applause.
“The key prevention of maternal morbidity and mortality associated with severe maternal hypertension is timely treatment; the primary cause of maternal death associated with hypertensive disorders of pregnancy is maternal hemorrhagic stroke,” said Dr. Lee King.
The multidisciplinary, multistakeholder project was coordinated by the Illinois Perinatal Quality Collaborative (ILPQC), housed at Northwestern University, Chicago. The participating hospitals account for over 95% of the births in the state of Illinois, said Dr. Lee King, ILPQC state project director.
The approach used for implementation of the hypertension QI initiative included collaborative learning and the use of rapid response data to give near–real time feedback on how institutions were faring in meeting national guidelines to treat severe maternal hypertension.
Specific clinical interventions included both “system changes and culture changes,” said Dr. Lee King. They included adopting facility-wide protocols for timely identification and treatment of women with severe maternal hypertension; standardizing patient education and discharge planning; increasing provider and nurse education about severe maternal hypertension protocols; and creating rapid access to medication and standardized treatment order sets.
The ILPQC facilitated collaboration between hospitals in meeting these aims, including monthly web-based updates and seminars and construction of the database that gave institutions rapid access to data for ongoing QI efforts. Newsletters, website updates, and QI support were also part of the ILPQC package.
The proportion of participating hospitals meeting time-to-treatment goals for severe maternal hypertension went from 13% at baseline to 71% at the end of data collection, said Dr. Lee King.
In looking at hospital characteristics such as rurality, size, and patient mix, Dr. Lee King and her collaborators found no significant differences in time to treatment, patient education, and number of cases that were debriefed.
“These strategies helped hospitals achieve initiative goals, regardless of hospital characteristics,” said Dr. Lee King. The only significant association the research team found was that hospitals with fewer than 500 deliveries per year were less likely to reach the goal of early follow-up appointments (P less than .02).
“Participation in a statewide perinatal quality collaborative increases hospitals’ QI capacity. A statewide QI initiative can achieve significant population-level improvements in care for women with severe maternal hypertension and – more importantly – a reduction in severe maternal morbidity,” Dr. Lee King said.
The QI initiative and the follow-up study were conducted by the Illinois Perinatal Quality Collaborative, and the work was funded by the Centers for Disease Control and Prevention, the Illinois Department of Health, and the Alliance for Intervention on Maternal Health. Materials related to the maternal hypertension initiative are available at http://ilpqc.org/?q=Hypertension. Dr. Lee King reported no conflicts of interest.
SOURCE: Lee King P et al. Am J Obstet Gynecol. 2018 Jan;218:S4.
REPORTING FROM THE PREGNANCY MEETING
Key clinical point: The statewide QI initiative targeted treatment of women with severe maternal hypertension.
Major finding: Severe maternal morbidity fell 41%, from 15% to 9%, with the initiative.
Study details: Pre-post QI initiative analysis of data from 102 Illinois hospitals treating 12,718 women with severe maternal hypertension.
Disclosures: The study was funded by the Centers for Disease Control and Prevention, the Illinois Department of Health, and the Alliance for Intervention on Mental Health. Dr. Lee King is employed by the Illinois Perinatal Quality Collaborative, which conducted the study.
Source: Lee King P et al. Am J Obstet Gynecol. 2018 Jan;218:S4.
Women aged 35-39 years at greater risk for stillbirth
Women aged 35 years and older had a higher risk for giving birth before 34 weeks of gestation but only women aged 35-39 years had a higher risk for stillbirth, according to research published online in Obstetrics & Gynecology.
Line Elmerdahl Frederiksen of Aarhus (Denmark) University and her colleagues compared outcomes for women aged 35-39 years and women aged 40 years or older with outcomes for women aged 20-34 years.
The researchers analyzed 369,516 singleton pregnancies in women who had a first-trimester screening between 11 and 14 weeks of gestation at a public hospital in Denmark between January 2008 and December 2014.
“In this study, we were able to include detected chromosomal abnormalities and congenital malformations from an early gestational age, which in other studies would not have been available for assessment,” the authors wrote. The researchers also included miscarriage, birth before 34 weeks of gestation, and stillbirth outcomes in their analysis.
The researchers reported an increased risk for giving birth before 34 weeks of gestation for women aged 35-39 years (odds ratio, 1.25) and for women aged 40 years or older (OR, 1.66). The authors wrote that this finding was contradictory to previously reported data and noted that obstetric complications, which are known to increase with age, could explain their finding.
Women aged 35-39 years had a higher risk for stillbirth, compared with women aged 20-34 years (OR, 1.43), according to the study. However, the researchers did not observe a similar risk for women aged 40 years or older. “This counterintuitive finding could possibly occur because induction of labor for comorbidities is more likely in women older than 40 years,” wrote Ms. Frederiksen and her coauthors.
The researchers reported increased risk for both miscarriage and chromosomal abnormalities for women aged 35-39 years and women aged 40 years or older, adding to the previously published risk association for older women. Risk for congenital malformations did not appear to differ between maternal age groups, which was also consistent with previous data.
In a composite risk analysis, researchers found an increased risk for an adverse pregnancy outcome for women aged 35-39 years (OR, 1.29) and women aged 40 years or older (OR, 2.02).
The authors reported no potential conflicts of interest.
SOURCE: Frederiksen L et al. Obstet Gynecol. 2018 Feb 5. doi: 10.1097/AOG.0000000000002504.
Women aged 35 years and older had a higher risk for giving birth before 34 weeks of gestation but only women aged 35-39 years had a higher risk for stillbirth, according to research published online in Obstetrics & Gynecology.
Line Elmerdahl Frederiksen of Aarhus (Denmark) University and her colleagues compared outcomes for women aged 35-39 years and women aged 40 years or older with outcomes for women aged 20-34 years.
The researchers analyzed 369,516 singleton pregnancies in women who had a first-trimester screening between 11 and 14 weeks of gestation at a public hospital in Denmark between January 2008 and December 2014.
“In this study, we were able to include detected chromosomal abnormalities and congenital malformations from an early gestational age, which in other studies would not have been available for assessment,” the authors wrote. The researchers also included miscarriage, birth before 34 weeks of gestation, and stillbirth outcomes in their analysis.
The researchers reported an increased risk for giving birth before 34 weeks of gestation for women aged 35-39 years (odds ratio, 1.25) and for women aged 40 years or older (OR, 1.66). The authors wrote that this finding was contradictory to previously reported data and noted that obstetric complications, which are known to increase with age, could explain their finding.
Women aged 35-39 years had a higher risk for stillbirth, compared with women aged 20-34 years (OR, 1.43), according to the study. However, the researchers did not observe a similar risk for women aged 40 years or older. “This counterintuitive finding could possibly occur because induction of labor for comorbidities is more likely in women older than 40 years,” wrote Ms. Frederiksen and her coauthors.
The researchers reported increased risk for both miscarriage and chromosomal abnormalities for women aged 35-39 years and women aged 40 years or older, adding to the previously published risk association for older women. Risk for congenital malformations did not appear to differ between maternal age groups, which was also consistent with previous data.
In a composite risk analysis, researchers found an increased risk for an adverse pregnancy outcome for women aged 35-39 years (OR, 1.29) and women aged 40 years or older (OR, 2.02).
The authors reported no potential conflicts of interest.
SOURCE: Frederiksen L et al. Obstet Gynecol. 2018 Feb 5. doi: 10.1097/AOG.0000000000002504.
Women aged 35 years and older had a higher risk for giving birth before 34 weeks of gestation but only women aged 35-39 years had a higher risk for stillbirth, according to research published online in Obstetrics & Gynecology.
Line Elmerdahl Frederiksen of Aarhus (Denmark) University and her colleagues compared outcomes for women aged 35-39 years and women aged 40 years or older with outcomes for women aged 20-34 years.
The researchers analyzed 369,516 singleton pregnancies in women who had a first-trimester screening between 11 and 14 weeks of gestation at a public hospital in Denmark between January 2008 and December 2014.
“In this study, we were able to include detected chromosomal abnormalities and congenital malformations from an early gestational age, which in other studies would not have been available for assessment,” the authors wrote. The researchers also included miscarriage, birth before 34 weeks of gestation, and stillbirth outcomes in their analysis.
The researchers reported an increased risk for giving birth before 34 weeks of gestation for women aged 35-39 years (odds ratio, 1.25) and for women aged 40 years or older (OR, 1.66). The authors wrote that this finding was contradictory to previously reported data and noted that obstetric complications, which are known to increase with age, could explain their finding.
Women aged 35-39 years had a higher risk for stillbirth, compared with women aged 20-34 years (OR, 1.43), according to the study. However, the researchers did not observe a similar risk for women aged 40 years or older. “This counterintuitive finding could possibly occur because induction of labor for comorbidities is more likely in women older than 40 years,” wrote Ms. Frederiksen and her coauthors.
The researchers reported increased risk for both miscarriage and chromosomal abnormalities for women aged 35-39 years and women aged 40 years or older, adding to the previously published risk association for older women. Risk for congenital malformations did not appear to differ between maternal age groups, which was also consistent with previous data.
In a composite risk analysis, researchers found an increased risk for an adverse pregnancy outcome for women aged 35-39 years (OR, 1.29) and women aged 40 years or older (OR, 2.02).
The authors reported no potential conflicts of interest.
SOURCE: Frederiksen L et al. Obstet Gynecol. 2018 Feb 5. doi: 10.1097/AOG.0000000000002504.
FROM OBSTETRICS & GYNECOLOGY
Key clinical point: Women aged 35-39 years are at greater risk of stillbirth than women aged 40 years or older.
Major finding: Women aged 40 years and older were at greater risk of chromosomal abnormalities than women aged 20-34 years (3.83% vs. 0.56%; OR, 7.44).
Data source: A nationwide cohort study of 369,516 singleton pregnancies.
Disclosures: Ms. Frederiksen reported having no financial disclosures.
Source: Frederiksen L et al. Obstet Gynecol. 2018 Feb 5. doi: 10.1097/AOG.0000000000002504.
Perfusion-only scan rules out PE in pregnancy
For pregnant women with suspected pulmonary embolism (PE), (CTPA), according to authors of a recent retrospective study.
Pulmonary embolism causes 9% of maternal deaths in the United States, according to the authors of the study, which was published online in the journal CHEST®. While it’s clear that perfusion scans yield lower radiation exposure than CTPA, to date, there has only been limited study of its diagnostic performance in women with suspected PE.
The low-dose perfusion scan offered comparable diagnostic efficacy while potentially limiting radiation exposure, according to the single-center cohort study.
The retrospective study included pregnant women (mean age, 27.3 years) who underwent imaging for pulmonary embolism at Montefiore Medical Center, New York, between 2008 and 2013. A total of 225 women underwent perfusion-only scans, while 97 underwent CTPA.
Chest pain and dyspnea were the most common symptoms for patients in both groups: 136 of the patients (60.4%) in the low-dose perfusion group reported chest pain versus 40 patients (41.2%) in the CTPA group. About half of the patients in both groups had dyspnea.
Tachycardia was found in 43 of patients (44.3%) who underwent CTPA, compared with 77 of patients (34.2% ) who underwent the diagnostic test involving less radiation exposure.
Imaging was negative for PE in 198 of the patients (88.0%) who were scanned with low-dose perfusion, while 84 of patients (86.6%) who had CTPAs were negative for PE. For both groups of patients, the percentage who had indeterminate imaging was 9.3%. Only one study participant had a deep vein thrombosis at the time she presented with PE symptoms.
The primary end point of the study, negative predictive value, was 100% for the perfusion-only group and 97.5% for CTPA, according to the report. It was determined by a diagnosis of venous thromboembolism within 90 days of evaluation.
Those “indistinguishable” negative predictive values suggest that low-dose perfusion scintigraphy performs comparably to CTPA, making it an appropriate first diagnostic modality for pregnant women who are suspected of having pulmonary embolism, Dr. Sheen and her colleagues wrote.
The negative predictive value was a particularly important endpoint to evaluate because pulmonary embolism is rare among pregnant women and most perfusion-only imaging is negative, the authors stated.
Of the women in the study, 252 (89%) of those who tested negative for PE – either by a low-dose perfusion scan or a CTPA – returned to the medical center for follow-up 90 days later. Thromboembolic events occurred in two of the women who previously had a negative CTPA, but none occurred in patients who had been tested for PE with low-dose perfusion scan. The two thromboembolic events were detected in women who were no longer pregnant.
Ten patients in the study (3.1%) were treated for pulmonary embolism, the authors reported. The PE diagnoses were based on four positive low-dose perfusion scans and six positive CTPAs “in conjunction with clinical suspicion.” These patients’ most common symptoms were chest pain and dyspnea, and one of these patients had recently been diagnosed with a deep vein thrombosis.
When perfusion defects are found, they should be interpreted cautiously, particularly in asthmatic patients, according to authors: “Segmental perfusion defects secondary to abnormal ventilation cannot be distinguished from PE without a ventilation scan,”they noted.
Three of the patients diagnosed with a PE had asthma. In a subanalysis of the 77 patients with asthma who participated in this study, the negative predictive values were 100% for both those who received a low-dose perfusion scan and those who received a CTPA. For patients in this subgroup, the negative rates of PE from low-dose perfusion scan and CTPA were 74.1% and 87.1%, respectively.
“Maternal-fetal radiation exposure should be of utmost importance when considering the choice of diagnostic test,” the authors wrote. “When available, [a low-dose perfusion scan] is a reasonable first choice modality for suspected pulmonary embolism in pregnant women with a negative chest radiograph.”
One study coauthor is on an advisory panel for Jubilant DraxImage, and another has a spouse who is a board member of Kyron Pharma Consulting. The remaining authors, including Dr. Sheen,reported no conflicts of interest.
SOURCE: Sheen JJ et al. Chest. 2018 Feb. doi: 10.1016/j.chest.2017.08.005.
Nirmal Sharma, MD, comments: During pregnancy, all radiation is bad radiation, but when it was really needed, we did use this low-radiation perfusion scan quite a bit at my past institution. This article definitely shines light on the utility/validity of this technique because most centers still use a computed tomographic pulmonary angiography study in pregnant females (with shielding methods) if suspicion of pulmonary embolism is high. The downside to low-dose perfusion scintigraphy is that it cannot be used in patients with grossly abnormal chest x-rays.
Nirmal Sharma, MD, comments: During pregnancy, all radiation is bad radiation, but when it was really needed, we did use this low-radiation perfusion scan quite a bit at my past institution. This article definitely shines light on the utility/validity of this technique because most centers still use a computed tomographic pulmonary angiography study in pregnant females (with shielding methods) if suspicion of pulmonary embolism is high. The downside to low-dose perfusion scintigraphy is that it cannot be used in patients with grossly abnormal chest x-rays.
Nirmal Sharma, MD, comments: During pregnancy, all radiation is bad radiation, but when it was really needed, we did use this low-radiation perfusion scan quite a bit at my past institution. This article definitely shines light on the utility/validity of this technique because most centers still use a computed tomographic pulmonary angiography study in pregnant females (with shielding methods) if suspicion of pulmonary embolism is high. The downside to low-dose perfusion scintigraphy is that it cannot be used in patients with grossly abnormal chest x-rays.
For pregnant women with suspected pulmonary embolism (PE), (CTPA), according to authors of a recent retrospective study.
Pulmonary embolism causes 9% of maternal deaths in the United States, according to the authors of the study, which was published online in the journal CHEST®. While it’s clear that perfusion scans yield lower radiation exposure than CTPA, to date, there has only been limited study of its diagnostic performance in women with suspected PE.
The low-dose perfusion scan offered comparable diagnostic efficacy while potentially limiting radiation exposure, according to the single-center cohort study.
The retrospective study included pregnant women (mean age, 27.3 years) who underwent imaging for pulmonary embolism at Montefiore Medical Center, New York, between 2008 and 2013. A total of 225 women underwent perfusion-only scans, while 97 underwent CTPA.
Chest pain and dyspnea were the most common symptoms for patients in both groups: 136 of the patients (60.4%) in the low-dose perfusion group reported chest pain versus 40 patients (41.2%) in the CTPA group. About half of the patients in both groups had dyspnea.
Tachycardia was found in 43 of patients (44.3%) who underwent CTPA, compared with 77 of patients (34.2% ) who underwent the diagnostic test involving less radiation exposure.
Imaging was negative for PE in 198 of the patients (88.0%) who were scanned with low-dose perfusion, while 84 of patients (86.6%) who had CTPAs were negative for PE. For both groups of patients, the percentage who had indeterminate imaging was 9.3%. Only one study participant had a deep vein thrombosis at the time she presented with PE symptoms.
The primary end point of the study, negative predictive value, was 100% for the perfusion-only group and 97.5% for CTPA, according to the report. It was determined by a diagnosis of venous thromboembolism within 90 days of evaluation.
Those “indistinguishable” negative predictive values suggest that low-dose perfusion scintigraphy performs comparably to CTPA, making it an appropriate first diagnostic modality for pregnant women who are suspected of having pulmonary embolism, Dr. Sheen and her colleagues wrote.
The negative predictive value was a particularly important endpoint to evaluate because pulmonary embolism is rare among pregnant women and most perfusion-only imaging is negative, the authors stated.
Of the women in the study, 252 (89%) of those who tested negative for PE – either by a low-dose perfusion scan or a CTPA – returned to the medical center for follow-up 90 days later. Thromboembolic events occurred in two of the women who previously had a negative CTPA, but none occurred in patients who had been tested for PE with low-dose perfusion scan. The two thromboembolic events were detected in women who were no longer pregnant.
Ten patients in the study (3.1%) were treated for pulmonary embolism, the authors reported. The PE diagnoses were based on four positive low-dose perfusion scans and six positive CTPAs “in conjunction with clinical suspicion.” These patients’ most common symptoms were chest pain and dyspnea, and one of these patients had recently been diagnosed with a deep vein thrombosis.
When perfusion defects are found, they should be interpreted cautiously, particularly in asthmatic patients, according to authors: “Segmental perfusion defects secondary to abnormal ventilation cannot be distinguished from PE without a ventilation scan,”they noted.
Three of the patients diagnosed with a PE had asthma. In a subanalysis of the 77 patients with asthma who participated in this study, the negative predictive values were 100% for both those who received a low-dose perfusion scan and those who received a CTPA. For patients in this subgroup, the negative rates of PE from low-dose perfusion scan and CTPA were 74.1% and 87.1%, respectively.
“Maternal-fetal radiation exposure should be of utmost importance when considering the choice of diagnostic test,” the authors wrote. “When available, [a low-dose perfusion scan] is a reasonable first choice modality for suspected pulmonary embolism in pregnant women with a negative chest radiograph.”
One study coauthor is on an advisory panel for Jubilant DraxImage, and another has a spouse who is a board member of Kyron Pharma Consulting. The remaining authors, including Dr. Sheen,reported no conflicts of interest.
SOURCE: Sheen JJ et al. Chest. 2018 Feb. doi: 10.1016/j.chest.2017.08.005.
For pregnant women with suspected pulmonary embolism (PE), (CTPA), according to authors of a recent retrospective study.
Pulmonary embolism causes 9% of maternal deaths in the United States, according to the authors of the study, which was published online in the journal CHEST®. While it’s clear that perfusion scans yield lower radiation exposure than CTPA, to date, there has only been limited study of its diagnostic performance in women with suspected PE.
The low-dose perfusion scan offered comparable diagnostic efficacy while potentially limiting radiation exposure, according to the single-center cohort study.
The retrospective study included pregnant women (mean age, 27.3 years) who underwent imaging for pulmonary embolism at Montefiore Medical Center, New York, between 2008 and 2013. A total of 225 women underwent perfusion-only scans, while 97 underwent CTPA.
Chest pain and dyspnea were the most common symptoms for patients in both groups: 136 of the patients (60.4%) in the low-dose perfusion group reported chest pain versus 40 patients (41.2%) in the CTPA group. About half of the patients in both groups had dyspnea.
Tachycardia was found in 43 of patients (44.3%) who underwent CTPA, compared with 77 of patients (34.2% ) who underwent the diagnostic test involving less radiation exposure.
Imaging was negative for PE in 198 of the patients (88.0%) who were scanned with low-dose perfusion, while 84 of patients (86.6%) who had CTPAs were negative for PE. For both groups of patients, the percentage who had indeterminate imaging was 9.3%. Only one study participant had a deep vein thrombosis at the time she presented with PE symptoms.
The primary end point of the study, negative predictive value, was 100% for the perfusion-only group and 97.5% for CTPA, according to the report. It was determined by a diagnosis of venous thromboembolism within 90 days of evaluation.
Those “indistinguishable” negative predictive values suggest that low-dose perfusion scintigraphy performs comparably to CTPA, making it an appropriate first diagnostic modality for pregnant women who are suspected of having pulmonary embolism, Dr. Sheen and her colleagues wrote.
The negative predictive value was a particularly important endpoint to evaluate because pulmonary embolism is rare among pregnant women and most perfusion-only imaging is negative, the authors stated.
Of the women in the study, 252 (89%) of those who tested negative for PE – either by a low-dose perfusion scan or a CTPA – returned to the medical center for follow-up 90 days later. Thromboembolic events occurred in two of the women who previously had a negative CTPA, but none occurred in patients who had been tested for PE with low-dose perfusion scan. The two thromboembolic events were detected in women who were no longer pregnant.
Ten patients in the study (3.1%) were treated for pulmonary embolism, the authors reported. The PE diagnoses were based on four positive low-dose perfusion scans and six positive CTPAs “in conjunction with clinical suspicion.” These patients’ most common symptoms were chest pain and dyspnea, and one of these patients had recently been diagnosed with a deep vein thrombosis.
When perfusion defects are found, they should be interpreted cautiously, particularly in asthmatic patients, according to authors: “Segmental perfusion defects secondary to abnormal ventilation cannot be distinguished from PE without a ventilation scan,”they noted.
Three of the patients diagnosed with a PE had asthma. In a subanalysis of the 77 patients with asthma who participated in this study, the negative predictive values were 100% for both those who received a low-dose perfusion scan and those who received a CTPA. For patients in this subgroup, the negative rates of PE from low-dose perfusion scan and CTPA were 74.1% and 87.1%, respectively.
“Maternal-fetal radiation exposure should be of utmost importance when considering the choice of diagnostic test,” the authors wrote. “When available, [a low-dose perfusion scan] is a reasonable first choice modality for suspected pulmonary embolism in pregnant women with a negative chest radiograph.”
One study coauthor is on an advisory panel for Jubilant DraxImage, and another has a spouse who is a board member of Kyron Pharma Consulting. The remaining authors, including Dr. Sheen,reported no conflicts of interest.
SOURCE: Sheen JJ et al. Chest. 2018 Feb. doi: 10.1016/j.chest.2017.08.005.
FROM CHEST®
Key clinical point: In the evaluation of pregnant women with suspected pulmonary embolism, low-dose perfusion scintigraphy may offer diagnostic performance that’s comparable to CTPA.
Major finding: The negative predictive value of a pulmonary embolism was 100% for the low dose perfusion scan, compared with 97.5% for CTPA.
Study details: A retrospective, single-center cohort study including 322 pregnant women who underwent imaging studies for suspected pulmonary embolism.
Disclosures: One study coauthor is on an advisory panel for Jubilant DraxImage, and another has a spouse who is a board member of Kyron Pharma Consulting. The remaining authors, including Dr. Sheen,reported no conflicts of interest.
Source: Sheen JJ et al. Chest. 2018 Feb. doi: 10.1016/j.chest.2017.08.005.
Is 17-OHPC effective for reducing risk of preterm birth?
In 2003, the Eunice Kennedy Shriver National Institute of Child Health and Human Development’s Maternal-Fetal Medicine Units (MFMU) Network reported on a placebo-controlled randomized study of 17–alpha hydroxyprogesterone caproate (17-OHPC) in women with a history of spontaneous preterm delivery. The study demonstrated a 33% reduction in recurrent preterm birth after weekly treatment with 17-OHPC, which was initiated at 16-20 weeks of gestation.
This landmark study, led by Paul Meis, MD, validated what had been suggested in an earlier meta-analysis (1990) by Mark Keirse, MD – and it quickly altered clinical practice. It set into motion a string of studies on the use of 17-OHPC and other progestational compounds in women with a variety of conditions associated with an increased risk for preterm birth.
It is not surprising, then, that the literature has become muddied and full of contradictory findings since publication of the Meis study and the initial studies on vaginal progesterone in women with a midtrimester short cervix. Further confounding our ability to judge a treatment’s effectiveness is the fact that spontaneous preterm birth is increasingly understood to be a multifactorial, highly heterogeneous condition. We cannot, with a broad stroke, say that all women with a prior preterm birth, for instance, will respond to progestogens in a similar manner or are at the same level of risk of recurrent spontaneous preterm birth (sPTB).
The number of large, randomized clinical trials evaluating progestins is actually quite small but opinions abound about the data from these studies. Below, I have categorized these treatments according to my view at this time of the currently available data.
Consensus
One area in which there is agreement concerns the use of 17-OHPC intramuscular injections in multifetal gestations. Two randomized clinical trials undertaken by the MFMU Network – one in twins and one in triplets – concluded that 17-OHPC is ineffective in reducing the rate of preterm birth. Moreover, in another, more recent MFMU Network study, there was a negative linear relationship between concentrations of 17-OHPC and gestational age at delivery. Women with twin gestations who had higher concentrations of 17-OHPC delivered at earlier gestational ages than women with lower concentrations (Am J Obstet Gynecol. 2012;207[5]:396.e1-8).
Other investigators have similarly shown in clinical trials that the preterm birth rate actually seems to be worsened in multifetal gestations when 17-OHPC is used. There is now widespread agreement that the compound should not be used in these patients.
In addition, an MFMU Network study led by William A. Grobman, MD, demonstrated that 17-OHPC (250-mg injections) does not provide any benefit to nulliparous women with a sonographic cervical length less than 30 mm (Am J Obstet Gynecol. 2012;207[5]:390.e1-8). Other studies utilizing higher doses of 17-OHPC similarly found no benefit. There is also agreement that 17-OHPC has no benefit in treating women with preterm premature rupture of the membranes, preterm labor, or as a maintenance treatment after an episode of preterm labor.
General agreement without consensus
There is general agreement that women with a singleton gestation and a prior spontaneous preterm birth should be offered 17-OHPC, and that women with a singleton gestation and a midtrimester shortened cervical length should be offered vaginal progesterone and not 17-OHPC. However, even in these populations, there are questions about efficacy, dosing, and other issues.
In the Meis study (N Engl J Med. 2003;348:2379-85), treatment with 17-OHPC in women with a singleton gestation and a prior preterm delivery significantly reduced the risk of another preterm birth at less than 37 weeks’ gestation (36.3% in the progesterone group vs. 54.9% in the placebo group; relative risk, 0.66), at less than 35 weeks’ gestation (RR, 0.67), and at less than 32 weeks’ gestation (RR, 0.58). The exceptionally high rate of preterm delivery in the placebo group, however, prompted other investigators to express concern in published correspondence that the study was potentially flawed.
We reported an inverse relationship between 17-OHPC concentration and spontaneous preterm birth as part of a study conducted with the MFMU Network and the Obstetrical-Fetal Pharmacology Research Units Network. All women in the study had singleton gestations and received 250 mg weekly 17-OHPC (the broader study was designed to evaluate the benefit of omega-3 supplementation). We measured plasma concentrations of 17-OHPC and found that women with concentrations in the lowest quartile had a significantly higher risk of preterm birth and delivered at significantly earlier gestational ages than did women in the second through fourth quartiles (Am J Obstet Gynecol. 2014;210[2]:128.e1-6).
Other studies/abstracts similarly evaluating the relationship between 17-OHPC concentrations and preterm birth have reported mixed results, with both validation and refutation of our findings.
Research underway may help settle the controversy. In an ongoing, open-label pharmacology study being conducted by the Obstetrical-Fetal Pharmacology Research Units Network, women with singleton pregnancies and a history of prior preterm birth are being randomly assigned to receive either 250 mg (the empirically chosen, currently recommended dose) or 500 mg 17-OHPC. A relationship between the plasma concentration of 17-OHPC at 26-30 weeks’ gestation and the incidence of preterm birth would offer proof of efficacy and could help elucidate the therapeutic dosing; if there is no relationship, we revert to the question of whether the agent really works. Based on current evidence, both the Society for Maternal-Fetal Medicine (SMFM) and the American College of Obstetricians and Gynecologists (ACOG) support the use of 17-OHPC for prevention of sPTB in women with a prior sPTB.
Questions about vaginal progesterone have also been somewhat unsettled. Eduardo B. Fonseca, MD, reported in 2007 that asymptomatic women with a short cervix (defined as 15 mm or less) who were randomized to receive vaginal progesterone at a median of 22 weeks’ gestation had a significantly lower rate of preterm birth before 34 weeks’ gestation than those who received placebo (RR, 0.56; N Engl J Med. 2007;357[5]:462-9). Research that followed offered mixed conclusions, with a study by Sonia S. Hassan, MD, showing benefit and a study by Jane E. Norman, MD, showing no benefit. Notably, in 2012, the Food and Drug Administration voted against approval of a sustained-release progesterone vaginal gel, citing research results that were not sufficiently compelling.
Still, vaginal progesterone has been endorsed by both ACOG and by the SMFM for women with a short cervical length in the midtrimester. This is supported by a new review and meta-analysis of individual patient data by Roberto Romero, MD, in which vaginal progesterone was found to significantly decrease the risk of preterm birth in singleton gestations with a midtrimester cervical length of 25 mm or less. The reduction occurred over a wide range of gestational ages, including at less than 33 weeks of gestation (RR, 0.62; Am J Obstet Gynecol. 2018 Feb;218[2]:161-80).
Disagreement
Some have argued that vaginal progesterone should be offered to women with a history of prior spontaneous preterm birth, but the largest study to look at this application – a randomized multinational trial reported by John M. O’Brien, MD, and his colleagues in 2007 – found that use of the compound did not reduce the frequency of recurrent preterm birth at or before 32 weeks. Others have argued that vaginal progesterone is of benefit in this group of women based on a combination of multiple subgroup analyses. There is disagreement between ACOG and SMFM on this issue. ACOG supports the use of vaginal progesterone for women with a prior preterm birth but the SMFM strongly rejects this treatment and only endorses 17-OHPC for this indication.
Unresolved
The value of vaginal progesterone supplementation in reducing preterm births in women with twin gestations is under continuing investigation, including a study of women with twin gestation and a short cervix. This MFMU Network randomized trial, now underway, is evaluating the effectiveness of vaginal progesterone or pessary, compared with placebo, in preventing early preterm birth in women carrying twins who have a cervical length less than 30 mm.
Another question about the use of progesterone concerns the woman who delivered preterm during a twin gestation and is now pregnant with a singleton gestation. Should anything be offered to her? This is a question that has not yet been addressed in the literature.
What does seem clear is that spontaneous preterm birth is a multifactorial condition with numerous causes, and quite possibly an interaction between genetics, maternal characteristics, and the environment surrounding each pregnancy (Semin Perinatol. 2016;40[5]:273-80). Certainly, there are different pathways and mechanisms at play in patients who deliver at 35-36 weeks, for instance, compared with those who deliver at 25-26 weeks.
We recently obtained cervical fluid from pregnant women with prior preterm births and analyzed the samples for concentrations of cytokines and matrix metalloproteinases. Women with a prior early preterm delivery at less than 26 weeks had elevations in five cervical cytokines – an inflammatory signature, in essence – while those whose prior preterm birth occurred at a later gestational age had no elevations of these cytokines (Am J Perinatol. 2017 Nov 15. doi: 10.1055/s-0037-1608631).
Hopefully, we soon will be able to identify subpopulations of pregnant women who will benefit more from progesterone supplementation. More research needs to be done at a granular level, with more narrowly defined populations – and with consideration of various pharmacologic, genetic and environmental factors – in order to develop a more specific treatment approach. In the meantime, it is important to appreciate the unknowns that underlie the highly variable clinical responses and outcomes seen in our clinical trials.
Dr. Caritis is professor of obstetrics, gynecology, and reproductive sciences at Magee-Womens Hospital, University of Pittsburgh. He has no disclosures relevant to this Master Class.
In 2003, the Eunice Kennedy Shriver National Institute of Child Health and Human Development’s Maternal-Fetal Medicine Units (MFMU) Network reported on a placebo-controlled randomized study of 17–alpha hydroxyprogesterone caproate (17-OHPC) in women with a history of spontaneous preterm delivery. The study demonstrated a 33% reduction in recurrent preterm birth after weekly treatment with 17-OHPC, which was initiated at 16-20 weeks of gestation.
This landmark study, led by Paul Meis, MD, validated what had been suggested in an earlier meta-analysis (1990) by Mark Keirse, MD – and it quickly altered clinical practice. It set into motion a string of studies on the use of 17-OHPC and other progestational compounds in women with a variety of conditions associated with an increased risk for preterm birth.
It is not surprising, then, that the literature has become muddied and full of contradictory findings since publication of the Meis study and the initial studies on vaginal progesterone in women with a midtrimester short cervix. Further confounding our ability to judge a treatment’s effectiveness is the fact that spontaneous preterm birth is increasingly understood to be a multifactorial, highly heterogeneous condition. We cannot, with a broad stroke, say that all women with a prior preterm birth, for instance, will respond to progestogens in a similar manner or are at the same level of risk of recurrent spontaneous preterm birth (sPTB).
The number of large, randomized clinical trials evaluating progestins is actually quite small but opinions abound about the data from these studies. Below, I have categorized these treatments according to my view at this time of the currently available data.
Consensus
One area in which there is agreement concerns the use of 17-OHPC intramuscular injections in multifetal gestations. Two randomized clinical trials undertaken by the MFMU Network – one in twins and one in triplets – concluded that 17-OHPC is ineffective in reducing the rate of preterm birth. Moreover, in another, more recent MFMU Network study, there was a negative linear relationship between concentrations of 17-OHPC and gestational age at delivery. Women with twin gestations who had higher concentrations of 17-OHPC delivered at earlier gestational ages than women with lower concentrations (Am J Obstet Gynecol. 2012;207[5]:396.e1-8).
Other investigators have similarly shown in clinical trials that the preterm birth rate actually seems to be worsened in multifetal gestations when 17-OHPC is used. There is now widespread agreement that the compound should not be used in these patients.
In addition, an MFMU Network study led by William A. Grobman, MD, demonstrated that 17-OHPC (250-mg injections) does not provide any benefit to nulliparous women with a sonographic cervical length less than 30 mm (Am J Obstet Gynecol. 2012;207[5]:390.e1-8). Other studies utilizing higher doses of 17-OHPC similarly found no benefit. There is also agreement that 17-OHPC has no benefit in treating women with preterm premature rupture of the membranes, preterm labor, or as a maintenance treatment after an episode of preterm labor.
General agreement without consensus
There is general agreement that women with a singleton gestation and a prior spontaneous preterm birth should be offered 17-OHPC, and that women with a singleton gestation and a midtrimester shortened cervical length should be offered vaginal progesterone and not 17-OHPC. However, even in these populations, there are questions about efficacy, dosing, and other issues.
In the Meis study (N Engl J Med. 2003;348:2379-85), treatment with 17-OHPC in women with a singleton gestation and a prior preterm delivery significantly reduced the risk of another preterm birth at less than 37 weeks’ gestation (36.3% in the progesterone group vs. 54.9% in the placebo group; relative risk, 0.66), at less than 35 weeks’ gestation (RR, 0.67), and at less than 32 weeks’ gestation (RR, 0.58). The exceptionally high rate of preterm delivery in the placebo group, however, prompted other investigators to express concern in published correspondence that the study was potentially flawed.
We reported an inverse relationship between 17-OHPC concentration and spontaneous preterm birth as part of a study conducted with the MFMU Network and the Obstetrical-Fetal Pharmacology Research Units Network. All women in the study had singleton gestations and received 250 mg weekly 17-OHPC (the broader study was designed to evaluate the benefit of omega-3 supplementation). We measured plasma concentrations of 17-OHPC and found that women with concentrations in the lowest quartile had a significantly higher risk of preterm birth and delivered at significantly earlier gestational ages than did women in the second through fourth quartiles (Am J Obstet Gynecol. 2014;210[2]:128.e1-6).
Other studies/abstracts similarly evaluating the relationship between 17-OHPC concentrations and preterm birth have reported mixed results, with both validation and refutation of our findings.
Research underway may help settle the controversy. In an ongoing, open-label pharmacology study being conducted by the Obstetrical-Fetal Pharmacology Research Units Network, women with singleton pregnancies and a history of prior preterm birth are being randomly assigned to receive either 250 mg (the empirically chosen, currently recommended dose) or 500 mg 17-OHPC. A relationship between the plasma concentration of 17-OHPC at 26-30 weeks’ gestation and the incidence of preterm birth would offer proof of efficacy and could help elucidate the therapeutic dosing; if there is no relationship, we revert to the question of whether the agent really works. Based on current evidence, both the Society for Maternal-Fetal Medicine (SMFM) and the American College of Obstetricians and Gynecologists (ACOG) support the use of 17-OHPC for prevention of sPTB in women with a prior sPTB.
Questions about vaginal progesterone have also been somewhat unsettled. Eduardo B. Fonseca, MD, reported in 2007 that asymptomatic women with a short cervix (defined as 15 mm or less) who were randomized to receive vaginal progesterone at a median of 22 weeks’ gestation had a significantly lower rate of preterm birth before 34 weeks’ gestation than those who received placebo (RR, 0.56; N Engl J Med. 2007;357[5]:462-9). Research that followed offered mixed conclusions, with a study by Sonia S. Hassan, MD, showing benefit and a study by Jane E. Norman, MD, showing no benefit. Notably, in 2012, the Food and Drug Administration voted against approval of a sustained-release progesterone vaginal gel, citing research results that were not sufficiently compelling.
Still, vaginal progesterone has been endorsed by both ACOG and by the SMFM for women with a short cervical length in the midtrimester. This is supported by a new review and meta-analysis of individual patient data by Roberto Romero, MD, in which vaginal progesterone was found to significantly decrease the risk of preterm birth in singleton gestations with a midtrimester cervical length of 25 mm or less. The reduction occurred over a wide range of gestational ages, including at less than 33 weeks of gestation (RR, 0.62; Am J Obstet Gynecol. 2018 Feb;218[2]:161-80).
Disagreement
Some have argued that vaginal progesterone should be offered to women with a history of prior spontaneous preterm birth, but the largest study to look at this application – a randomized multinational trial reported by John M. O’Brien, MD, and his colleagues in 2007 – found that use of the compound did not reduce the frequency of recurrent preterm birth at or before 32 weeks. Others have argued that vaginal progesterone is of benefit in this group of women based on a combination of multiple subgroup analyses. There is disagreement between ACOG and SMFM on this issue. ACOG supports the use of vaginal progesterone for women with a prior preterm birth but the SMFM strongly rejects this treatment and only endorses 17-OHPC for this indication.
Unresolved
The value of vaginal progesterone supplementation in reducing preterm births in women with twin gestations is under continuing investigation, including a study of women with twin gestation and a short cervix. This MFMU Network randomized trial, now underway, is evaluating the effectiveness of vaginal progesterone or pessary, compared with placebo, in preventing early preterm birth in women carrying twins who have a cervical length less than 30 mm.
Another question about the use of progesterone concerns the woman who delivered preterm during a twin gestation and is now pregnant with a singleton gestation. Should anything be offered to her? This is a question that has not yet been addressed in the literature.
What does seem clear is that spontaneous preterm birth is a multifactorial condition with numerous causes, and quite possibly an interaction between genetics, maternal characteristics, and the environment surrounding each pregnancy (Semin Perinatol. 2016;40[5]:273-80). Certainly, there are different pathways and mechanisms at play in patients who deliver at 35-36 weeks, for instance, compared with those who deliver at 25-26 weeks.
We recently obtained cervical fluid from pregnant women with prior preterm births and analyzed the samples for concentrations of cytokines and matrix metalloproteinases. Women with a prior early preterm delivery at less than 26 weeks had elevations in five cervical cytokines – an inflammatory signature, in essence – while those whose prior preterm birth occurred at a later gestational age had no elevations of these cytokines (Am J Perinatol. 2017 Nov 15. doi: 10.1055/s-0037-1608631).
Hopefully, we soon will be able to identify subpopulations of pregnant women who will benefit more from progesterone supplementation. More research needs to be done at a granular level, with more narrowly defined populations – and with consideration of various pharmacologic, genetic and environmental factors – in order to develop a more specific treatment approach. In the meantime, it is important to appreciate the unknowns that underlie the highly variable clinical responses and outcomes seen in our clinical trials.
Dr. Caritis is professor of obstetrics, gynecology, and reproductive sciences at Magee-Womens Hospital, University of Pittsburgh. He has no disclosures relevant to this Master Class.
In 2003, the Eunice Kennedy Shriver National Institute of Child Health and Human Development’s Maternal-Fetal Medicine Units (MFMU) Network reported on a placebo-controlled randomized study of 17–alpha hydroxyprogesterone caproate (17-OHPC) in women with a history of spontaneous preterm delivery. The study demonstrated a 33% reduction in recurrent preterm birth after weekly treatment with 17-OHPC, which was initiated at 16-20 weeks of gestation.
This landmark study, led by Paul Meis, MD, validated what had been suggested in an earlier meta-analysis (1990) by Mark Keirse, MD – and it quickly altered clinical practice. It set into motion a string of studies on the use of 17-OHPC and other progestational compounds in women with a variety of conditions associated with an increased risk for preterm birth.
It is not surprising, then, that the literature has become muddied and full of contradictory findings since publication of the Meis study and the initial studies on vaginal progesterone in women with a midtrimester short cervix. Further confounding our ability to judge a treatment’s effectiveness is the fact that spontaneous preterm birth is increasingly understood to be a multifactorial, highly heterogeneous condition. We cannot, with a broad stroke, say that all women with a prior preterm birth, for instance, will respond to progestogens in a similar manner or are at the same level of risk of recurrent spontaneous preterm birth (sPTB).
The number of large, randomized clinical trials evaluating progestins is actually quite small but opinions abound about the data from these studies. Below, I have categorized these treatments according to my view at this time of the currently available data.
Consensus
One area in which there is agreement concerns the use of 17-OHPC intramuscular injections in multifetal gestations. Two randomized clinical trials undertaken by the MFMU Network – one in twins and one in triplets – concluded that 17-OHPC is ineffective in reducing the rate of preterm birth. Moreover, in another, more recent MFMU Network study, there was a negative linear relationship between concentrations of 17-OHPC and gestational age at delivery. Women with twin gestations who had higher concentrations of 17-OHPC delivered at earlier gestational ages than women with lower concentrations (Am J Obstet Gynecol. 2012;207[5]:396.e1-8).
Other investigators have similarly shown in clinical trials that the preterm birth rate actually seems to be worsened in multifetal gestations when 17-OHPC is used. There is now widespread agreement that the compound should not be used in these patients.
In addition, an MFMU Network study led by William A. Grobman, MD, demonstrated that 17-OHPC (250-mg injections) does not provide any benefit to nulliparous women with a sonographic cervical length less than 30 mm (Am J Obstet Gynecol. 2012;207[5]:390.e1-8). Other studies utilizing higher doses of 17-OHPC similarly found no benefit. There is also agreement that 17-OHPC has no benefit in treating women with preterm premature rupture of the membranes, preterm labor, or as a maintenance treatment after an episode of preterm labor.
General agreement without consensus
There is general agreement that women with a singleton gestation and a prior spontaneous preterm birth should be offered 17-OHPC, and that women with a singleton gestation and a midtrimester shortened cervical length should be offered vaginal progesterone and not 17-OHPC. However, even in these populations, there are questions about efficacy, dosing, and other issues.
In the Meis study (N Engl J Med. 2003;348:2379-85), treatment with 17-OHPC in women with a singleton gestation and a prior preterm delivery significantly reduced the risk of another preterm birth at less than 37 weeks’ gestation (36.3% in the progesterone group vs. 54.9% in the placebo group; relative risk, 0.66), at less than 35 weeks’ gestation (RR, 0.67), and at less than 32 weeks’ gestation (RR, 0.58). The exceptionally high rate of preterm delivery in the placebo group, however, prompted other investigators to express concern in published correspondence that the study was potentially flawed.
We reported an inverse relationship between 17-OHPC concentration and spontaneous preterm birth as part of a study conducted with the MFMU Network and the Obstetrical-Fetal Pharmacology Research Units Network. All women in the study had singleton gestations and received 250 mg weekly 17-OHPC (the broader study was designed to evaluate the benefit of omega-3 supplementation). We measured plasma concentrations of 17-OHPC and found that women with concentrations in the lowest quartile had a significantly higher risk of preterm birth and delivered at significantly earlier gestational ages than did women in the second through fourth quartiles (Am J Obstet Gynecol. 2014;210[2]:128.e1-6).
Other studies/abstracts similarly evaluating the relationship between 17-OHPC concentrations and preterm birth have reported mixed results, with both validation and refutation of our findings.
Research underway may help settle the controversy. In an ongoing, open-label pharmacology study being conducted by the Obstetrical-Fetal Pharmacology Research Units Network, women with singleton pregnancies and a history of prior preterm birth are being randomly assigned to receive either 250 mg (the empirically chosen, currently recommended dose) or 500 mg 17-OHPC. A relationship between the plasma concentration of 17-OHPC at 26-30 weeks’ gestation and the incidence of preterm birth would offer proof of efficacy and could help elucidate the therapeutic dosing; if there is no relationship, we revert to the question of whether the agent really works. Based on current evidence, both the Society for Maternal-Fetal Medicine (SMFM) and the American College of Obstetricians and Gynecologists (ACOG) support the use of 17-OHPC for prevention of sPTB in women with a prior sPTB.
Questions about vaginal progesterone have also been somewhat unsettled. Eduardo B. Fonseca, MD, reported in 2007 that asymptomatic women with a short cervix (defined as 15 mm or less) who were randomized to receive vaginal progesterone at a median of 22 weeks’ gestation had a significantly lower rate of preterm birth before 34 weeks’ gestation than those who received placebo (RR, 0.56; N Engl J Med. 2007;357[5]:462-9). Research that followed offered mixed conclusions, with a study by Sonia S. Hassan, MD, showing benefit and a study by Jane E. Norman, MD, showing no benefit. Notably, in 2012, the Food and Drug Administration voted against approval of a sustained-release progesterone vaginal gel, citing research results that were not sufficiently compelling.
Still, vaginal progesterone has been endorsed by both ACOG and by the SMFM for women with a short cervical length in the midtrimester. This is supported by a new review and meta-analysis of individual patient data by Roberto Romero, MD, in which vaginal progesterone was found to significantly decrease the risk of preterm birth in singleton gestations with a midtrimester cervical length of 25 mm or less. The reduction occurred over a wide range of gestational ages, including at less than 33 weeks of gestation (RR, 0.62; Am J Obstet Gynecol. 2018 Feb;218[2]:161-80).
Disagreement
Some have argued that vaginal progesterone should be offered to women with a history of prior spontaneous preterm birth, but the largest study to look at this application – a randomized multinational trial reported by John M. O’Brien, MD, and his colleagues in 2007 – found that use of the compound did not reduce the frequency of recurrent preterm birth at or before 32 weeks. Others have argued that vaginal progesterone is of benefit in this group of women based on a combination of multiple subgroup analyses. There is disagreement between ACOG and SMFM on this issue. ACOG supports the use of vaginal progesterone for women with a prior preterm birth but the SMFM strongly rejects this treatment and only endorses 17-OHPC for this indication.
Unresolved
The value of vaginal progesterone supplementation in reducing preterm births in women with twin gestations is under continuing investigation, including a study of women with twin gestation and a short cervix. This MFMU Network randomized trial, now underway, is evaluating the effectiveness of vaginal progesterone or pessary, compared with placebo, in preventing early preterm birth in women carrying twins who have a cervical length less than 30 mm.
Another question about the use of progesterone concerns the woman who delivered preterm during a twin gestation and is now pregnant with a singleton gestation. Should anything be offered to her? This is a question that has not yet been addressed in the literature.
What does seem clear is that spontaneous preterm birth is a multifactorial condition with numerous causes, and quite possibly an interaction between genetics, maternal characteristics, and the environment surrounding each pregnancy (Semin Perinatol. 2016;40[5]:273-80). Certainly, there are different pathways and mechanisms at play in patients who deliver at 35-36 weeks, for instance, compared with those who deliver at 25-26 weeks.
We recently obtained cervical fluid from pregnant women with prior preterm births and analyzed the samples for concentrations of cytokines and matrix metalloproteinases. Women with a prior early preterm delivery at less than 26 weeks had elevations in five cervical cytokines – an inflammatory signature, in essence – while those whose prior preterm birth occurred at a later gestational age had no elevations of these cytokines (Am J Perinatol. 2017 Nov 15. doi: 10.1055/s-0037-1608631).
Hopefully, we soon will be able to identify subpopulations of pregnant women who will benefit more from progesterone supplementation. More research needs to be done at a granular level, with more narrowly defined populations – and with consideration of various pharmacologic, genetic and environmental factors – in order to develop a more specific treatment approach. In the meantime, it is important to appreciate the unknowns that underlie the highly variable clinical responses and outcomes seen in our clinical trials.
Dr. Caritis is professor of obstetrics, gynecology, and reproductive sciences at Magee-Womens Hospital, University of Pittsburgh. He has no disclosures relevant to this Master Class.
For preterm birth, we must avoid being too quick to prescribe therapeutic measures
As ob.gyns., our decisions not only deeply affect the health and well-being of our patients, but can also dramatically impact their children and families. Perhaps nowhere else is the gravity of our medical choices more felt than in the management of premature labor. Premature birth is one of the major drivers of infant mortality, which remains a significant public health problem in the United States where the rate of infant mortality is nearly 6 of every 1,000 live births.
Therefore, when the two seminal studies were published that showed using injectable or vaginal progesterone successfully delayed labor with fewer neonatal complications, the findings were quickly embraced and applied clinically. However, subsequent studies indicated that progesterone is only beneficial to a certain subset of patients – those with singleton pregnancies and a short cervix. The variance in the results of this research highlights an important point: We must treat each patient as an individual, based on her unique medical history, circumstances, and, yes, symptoms. One size does not fit all.
Equally important is a greater need across our practice to avoid being too quick to prescribe therapeutic measures that do not treat the root of the problem. We must instead provide guidance based on rigorously conducted research and analysis. However, even very promising results should not necessarily be used to guide all of clinical practice, and certainly not without scrutiny and considerable analysis.
To dissect the available data and present the most current findings regarding progesterone use to prevent preterm labor, we have invited Steve Caritis, MD, professor of obstetrics, gynecology, and reproductive sciences at Magee-Womens Hospital, University of Pittsburgh, to be the guest author for this month’s Master Class.
Dr. Reece, who specializes in maternal-fetal medicine, is vice president for medical affairs at the University of Maryland, Baltimore, as well as the John Z. and Akiko K. Bowers Distinguished Professor and dean of the school of medicine. Dr. Reece said he had no relevant financial disclosures. He is the medical editor of this column. Contact him at [email protected].
As ob.gyns., our decisions not only deeply affect the health and well-being of our patients, but can also dramatically impact their children and families. Perhaps nowhere else is the gravity of our medical choices more felt than in the management of premature labor. Premature birth is one of the major drivers of infant mortality, which remains a significant public health problem in the United States where the rate of infant mortality is nearly 6 of every 1,000 live births.
Therefore, when the two seminal studies were published that showed using injectable or vaginal progesterone successfully delayed labor with fewer neonatal complications, the findings were quickly embraced and applied clinically. However, subsequent studies indicated that progesterone is only beneficial to a certain subset of patients – those with singleton pregnancies and a short cervix. The variance in the results of this research highlights an important point: We must treat each patient as an individual, based on her unique medical history, circumstances, and, yes, symptoms. One size does not fit all.
Equally important is a greater need across our practice to avoid being too quick to prescribe therapeutic measures that do not treat the root of the problem. We must instead provide guidance based on rigorously conducted research and analysis. However, even very promising results should not necessarily be used to guide all of clinical practice, and certainly not without scrutiny and considerable analysis.
To dissect the available data and present the most current findings regarding progesterone use to prevent preterm labor, we have invited Steve Caritis, MD, professor of obstetrics, gynecology, and reproductive sciences at Magee-Womens Hospital, University of Pittsburgh, to be the guest author for this month’s Master Class.
Dr. Reece, who specializes in maternal-fetal medicine, is vice president for medical affairs at the University of Maryland, Baltimore, as well as the John Z. and Akiko K. Bowers Distinguished Professor and dean of the school of medicine. Dr. Reece said he had no relevant financial disclosures. He is the medical editor of this column. Contact him at [email protected].
As ob.gyns., our decisions not only deeply affect the health and well-being of our patients, but can also dramatically impact their children and families. Perhaps nowhere else is the gravity of our medical choices more felt than in the management of premature labor. Premature birth is one of the major drivers of infant mortality, which remains a significant public health problem in the United States where the rate of infant mortality is nearly 6 of every 1,000 live births.
Therefore, when the two seminal studies were published that showed using injectable or vaginal progesterone successfully delayed labor with fewer neonatal complications, the findings were quickly embraced and applied clinically. However, subsequent studies indicated that progesterone is only beneficial to a certain subset of patients – those with singleton pregnancies and a short cervix. The variance in the results of this research highlights an important point: We must treat each patient as an individual, based on her unique medical history, circumstances, and, yes, symptoms. One size does not fit all.
Equally important is a greater need across our practice to avoid being too quick to prescribe therapeutic measures that do not treat the root of the problem. We must instead provide guidance based on rigorously conducted research and analysis. However, even very promising results should not necessarily be used to guide all of clinical practice, and certainly not without scrutiny and considerable analysis.
To dissect the available data and present the most current findings regarding progesterone use to prevent preterm labor, we have invited Steve Caritis, MD, professor of obstetrics, gynecology, and reproductive sciences at Magee-Womens Hospital, University of Pittsburgh, to be the guest author for this month’s Master Class.
Dr. Reece, who specializes in maternal-fetal medicine, is vice president for medical affairs at the University of Maryland, Baltimore, as well as the John Z. and Akiko K. Bowers Distinguished Professor and dean of the school of medicine. Dr. Reece said he had no relevant financial disclosures. He is the medical editor of this column. Contact him at [email protected].
Salpingectomy at cesarean feasible, but adds to operative time
DALLAS – Salpingectomy – which can reduce the risk for later ovarian cancer – was completed successfully in about two-thirds of women who desired permanent contraception at cesarean delivery and were randomized to receive this procedure rather than simple tubal ligation.
In a study of 80 patients, operative times were longer by 15 minutes for those who received salpingectomy, and neither group had adverse outcomes or serious complications, according to Akila Subramaniam, MD, who presented the findings of the single-site Salpingectomy at Cesarean Delivery for Ovarian Cancer Reduction (SCORE) trial at the meeting sponsored by the Society for Maternal-Fetal Medicine.
The strategy to perform salpingectomy during cesarean delivery may be one way to reduce the incidence of ovarian cancer, “the most lethal gynecologic malignancy in the United States,” said Dr. Subramaniam, a maternal-fetal medicine specialist at the University of Alabama at Birmingham. “Primary prevention is the focus to reduce the ovarian cancer burden.”
However, Dr. Subramaniam said, there had been limited prospective data on salpingectomy performed at the time of cesarean delivery. One theoretical concern is an increased risk of bleeding; another is the additional operative time required for a potentially difficult dissection of the entire fallopian tube.
Dr. Subramaniam and her colleagues constructed a clinical trial that asked patients who were receiving cesarean delivery and who desired surgical sterilization to agree to randomization to complete salpingectomy or standard tubal ligation. Patient allocation was determined by computer-generated numbers, placed in a sealed envelope, and revealed to the surgeon only at the time of the opening incision for the cesarean procedure. Patients were unaware of the allocation until hospital discharge.
The single-center trial enrolled women undergoing a planned cesarean delivery at 35 or more weeks’ gestation, including those who had previous cesareans and women with multiple gestations or fetal malpresentations. Women who went on to cesarean after a trial of labor after prior cesarean were also eligible.
Patients younger than 25 years and patients with known fetal anomalies or fetal demise were excluded, as were women with previous tubal surgery and those who were anticoagulated or had immunodeficiency. The study did not enroll women who were known to carry the BRCA mutation.
Patients who were randomized to the intervention arm received a complete salpingectomy involving excision from the fimbriae to within 1 cm of the cornua, when technically feasible. The control arm participants received a standard bilateral tubal ligation using either the modified Pomeroy technique or the Parkland technique.
All study participants received routine pre- and postoperative care and instructions, and had study follow-up visits at 1 and 6 weeks post partum.
The study had two primary endpoints: rate of bilateral completion of the randomized procedure, and mean total operative time measured from skin incision to closure. Secondary outcomes included assessments of blood loss and surgical complications, followed through the 6-week postpartum visit.
The study just met the predetermined statistical power needed to detect a 10-minute difference in operative time, enrolling 80 patients and randomizing 40 to each arm.
Of the 40 patients randomized to salpingectomy, 27 (67.5%) received the intended complete salpingectomy. Three had a unilateral salpingectomy, with a tubal ligation contralaterally. Eight patients received bilateral tubal ligations, and in two patients, the surgeon was unable to perform any sterilization procedure at all.
In the tubal ligation arm, 38 patients (95%) received bilateral tubal ligation, 1 patient received a unilateral tubal ligation and a unilateral salpingectomy, and 1 patient received no procedure. The difference in success of completing the intended procedures between the two study arms was statistically significant (P = .002); in both groups, adhesions and scarring were the primary impediments to successful completion of the intended procedure, Dr. Subramaniam said.
Operative times were longer by about 15 minutes in the salpingectomy arm, with the difference accounted for by the longer duration of the sterilization procedure. No significant differences were seen in estimated blood loss or decrease in hematocrit between the two groups, and pain scores were similar.
The study, which successfully recruited 80 women from 221 approached, “may be underpowered for safety outcomes,” said Dr. Subramaniam. She also pointed out that there was no assessment of ovarian reserve, and that it’s not possible to assess the true risk reduction of salpingectomy in this study design.
Still, “It’s reasonable to consider this surgical sterilization method during cesarean as an ovarian cancer risk-reducing strategy.” One impediment to study recruitment, she said, was that after receiving education about salpingectomy, many patients desired salpingectomy and were not willing to risk randomization to simple tubal ligation.
Dr. Subramaniam reported receiving research funding for the study from the Debra Kogan Lyda Memorial Ovarian Cancer Fund.
SOURCE: Subramaniam A et al. Am J Obstet Gynecol. 2018 Jan;218:S27-8.
DALLAS – Salpingectomy – which can reduce the risk for later ovarian cancer – was completed successfully in about two-thirds of women who desired permanent contraception at cesarean delivery and were randomized to receive this procedure rather than simple tubal ligation.
In a study of 80 patients, operative times were longer by 15 minutes for those who received salpingectomy, and neither group had adverse outcomes or serious complications, according to Akila Subramaniam, MD, who presented the findings of the single-site Salpingectomy at Cesarean Delivery for Ovarian Cancer Reduction (SCORE) trial at the meeting sponsored by the Society for Maternal-Fetal Medicine.
The strategy to perform salpingectomy during cesarean delivery may be one way to reduce the incidence of ovarian cancer, “the most lethal gynecologic malignancy in the United States,” said Dr. Subramaniam, a maternal-fetal medicine specialist at the University of Alabama at Birmingham. “Primary prevention is the focus to reduce the ovarian cancer burden.”
However, Dr. Subramaniam said, there had been limited prospective data on salpingectomy performed at the time of cesarean delivery. One theoretical concern is an increased risk of bleeding; another is the additional operative time required for a potentially difficult dissection of the entire fallopian tube.
Dr. Subramaniam and her colleagues constructed a clinical trial that asked patients who were receiving cesarean delivery and who desired surgical sterilization to agree to randomization to complete salpingectomy or standard tubal ligation. Patient allocation was determined by computer-generated numbers, placed in a sealed envelope, and revealed to the surgeon only at the time of the opening incision for the cesarean procedure. Patients were unaware of the allocation until hospital discharge.
The single-center trial enrolled women undergoing a planned cesarean delivery at 35 or more weeks’ gestation, including those who had previous cesareans and women with multiple gestations or fetal malpresentations. Women who went on to cesarean after a trial of labor after prior cesarean were also eligible.
Patients younger than 25 years and patients with known fetal anomalies or fetal demise were excluded, as were women with previous tubal surgery and those who were anticoagulated or had immunodeficiency. The study did not enroll women who were known to carry the BRCA mutation.
Patients who were randomized to the intervention arm received a complete salpingectomy involving excision from the fimbriae to within 1 cm of the cornua, when technically feasible. The control arm participants received a standard bilateral tubal ligation using either the modified Pomeroy technique or the Parkland technique.
All study participants received routine pre- and postoperative care and instructions, and had study follow-up visits at 1 and 6 weeks post partum.
The study had two primary endpoints: rate of bilateral completion of the randomized procedure, and mean total operative time measured from skin incision to closure. Secondary outcomes included assessments of blood loss and surgical complications, followed through the 6-week postpartum visit.
The study just met the predetermined statistical power needed to detect a 10-minute difference in operative time, enrolling 80 patients and randomizing 40 to each arm.
Of the 40 patients randomized to salpingectomy, 27 (67.5%) received the intended complete salpingectomy. Three had a unilateral salpingectomy, with a tubal ligation contralaterally. Eight patients received bilateral tubal ligations, and in two patients, the surgeon was unable to perform any sterilization procedure at all.
In the tubal ligation arm, 38 patients (95%) received bilateral tubal ligation, 1 patient received a unilateral tubal ligation and a unilateral salpingectomy, and 1 patient received no procedure. The difference in success of completing the intended procedures between the two study arms was statistically significant (P = .002); in both groups, adhesions and scarring were the primary impediments to successful completion of the intended procedure, Dr. Subramaniam said.
Operative times were longer by about 15 minutes in the salpingectomy arm, with the difference accounted for by the longer duration of the sterilization procedure. No significant differences were seen in estimated blood loss or decrease in hematocrit between the two groups, and pain scores were similar.
The study, which successfully recruited 80 women from 221 approached, “may be underpowered for safety outcomes,” said Dr. Subramaniam. She also pointed out that there was no assessment of ovarian reserve, and that it’s not possible to assess the true risk reduction of salpingectomy in this study design.
Still, “It’s reasonable to consider this surgical sterilization method during cesarean as an ovarian cancer risk-reducing strategy.” One impediment to study recruitment, she said, was that after receiving education about salpingectomy, many patients desired salpingectomy and were not willing to risk randomization to simple tubal ligation.
Dr. Subramaniam reported receiving research funding for the study from the Debra Kogan Lyda Memorial Ovarian Cancer Fund.
SOURCE: Subramaniam A et al. Am J Obstet Gynecol. 2018 Jan;218:S27-8.
DALLAS – Salpingectomy – which can reduce the risk for later ovarian cancer – was completed successfully in about two-thirds of women who desired permanent contraception at cesarean delivery and were randomized to receive this procedure rather than simple tubal ligation.
In a study of 80 patients, operative times were longer by 15 minutes for those who received salpingectomy, and neither group had adverse outcomes or serious complications, according to Akila Subramaniam, MD, who presented the findings of the single-site Salpingectomy at Cesarean Delivery for Ovarian Cancer Reduction (SCORE) trial at the meeting sponsored by the Society for Maternal-Fetal Medicine.
The strategy to perform salpingectomy during cesarean delivery may be one way to reduce the incidence of ovarian cancer, “the most lethal gynecologic malignancy in the United States,” said Dr. Subramaniam, a maternal-fetal medicine specialist at the University of Alabama at Birmingham. “Primary prevention is the focus to reduce the ovarian cancer burden.”
However, Dr. Subramaniam said, there had been limited prospective data on salpingectomy performed at the time of cesarean delivery. One theoretical concern is an increased risk of bleeding; another is the additional operative time required for a potentially difficult dissection of the entire fallopian tube.
Dr. Subramaniam and her colleagues constructed a clinical trial that asked patients who were receiving cesarean delivery and who desired surgical sterilization to agree to randomization to complete salpingectomy or standard tubal ligation. Patient allocation was determined by computer-generated numbers, placed in a sealed envelope, and revealed to the surgeon only at the time of the opening incision for the cesarean procedure. Patients were unaware of the allocation until hospital discharge.
The single-center trial enrolled women undergoing a planned cesarean delivery at 35 or more weeks’ gestation, including those who had previous cesareans and women with multiple gestations or fetal malpresentations. Women who went on to cesarean after a trial of labor after prior cesarean were also eligible.
Patients younger than 25 years and patients with known fetal anomalies or fetal demise were excluded, as were women with previous tubal surgery and those who were anticoagulated or had immunodeficiency. The study did not enroll women who were known to carry the BRCA mutation.
Patients who were randomized to the intervention arm received a complete salpingectomy involving excision from the fimbriae to within 1 cm of the cornua, when technically feasible. The control arm participants received a standard bilateral tubal ligation using either the modified Pomeroy technique or the Parkland technique.
All study participants received routine pre- and postoperative care and instructions, and had study follow-up visits at 1 and 6 weeks post partum.
The study had two primary endpoints: rate of bilateral completion of the randomized procedure, and mean total operative time measured from skin incision to closure. Secondary outcomes included assessments of blood loss and surgical complications, followed through the 6-week postpartum visit.
The study just met the predetermined statistical power needed to detect a 10-minute difference in operative time, enrolling 80 patients and randomizing 40 to each arm.
Of the 40 patients randomized to salpingectomy, 27 (67.5%) received the intended complete salpingectomy. Three had a unilateral salpingectomy, with a tubal ligation contralaterally. Eight patients received bilateral tubal ligations, and in two patients, the surgeon was unable to perform any sterilization procedure at all.
In the tubal ligation arm, 38 patients (95%) received bilateral tubal ligation, 1 patient received a unilateral tubal ligation and a unilateral salpingectomy, and 1 patient received no procedure. The difference in success of completing the intended procedures between the two study arms was statistically significant (P = .002); in both groups, adhesions and scarring were the primary impediments to successful completion of the intended procedure, Dr. Subramaniam said.
Operative times were longer by about 15 minutes in the salpingectomy arm, with the difference accounted for by the longer duration of the sterilization procedure. No significant differences were seen in estimated blood loss or decrease in hematocrit between the two groups, and pain scores were similar.
The study, which successfully recruited 80 women from 221 approached, “may be underpowered for safety outcomes,” said Dr. Subramaniam. She also pointed out that there was no assessment of ovarian reserve, and that it’s not possible to assess the true risk reduction of salpingectomy in this study design.
Still, “It’s reasonable to consider this surgical sterilization method during cesarean as an ovarian cancer risk-reducing strategy.” One impediment to study recruitment, she said, was that after receiving education about salpingectomy, many patients desired salpingectomy and were not willing to risk randomization to simple tubal ligation.
Dr. Subramaniam reported receiving research funding for the study from the Debra Kogan Lyda Memorial Ovarian Cancer Fund.
SOURCE: Subramaniam A et al. Am J Obstet Gynecol. 2018 Jan;218:S27-8.
REPORTING FROM THE PREGNANCY MEETING
Key clinical point: Salpingectomy was successful in two-thirds of patients but added 15 minutes to operative time.
Major finding: The intended procedure was successful in 27 of 40 salpingectomy patients (67.5%) and 38 of 40 tubal ligation patients (95%; P = .02).
Study details: Randomized controlled trial of 80 women receiving bilateral salpingectomy or tubal ligation at cesarean delivery.
Disclosures: Study funding was received from the Debra Kogan Lyda Memorial Ovarian Cancer Fund.
Source: Subramaniam A et al. Am J Obstet Gynecol. 2018 Jan;218:S27-8.
FDA approves new injection product to reduce preterm birth risk
Makena, a progestin injection for the prevention of preterm birth that has been approved for use since 2011, has received U.S. Food and Drug Administration approval for a subcutaneous auto-injection product to supplant its intramuscular injection formulation, announced its manufacturer, AMAG Pharmaceuticals, on Feb. 14.
The intramuscular injection’s 7-year orphan drug exclusivity expired earlier in February. AMAG plans to offer both products priced at parity, according to the company’s press release. The newer product has a smaller, thinner needle. Both products are intended for use in a woman who has a singleton pregnancy of less than 37 weeks’ gestation and who has had a prior spontaneous preterm singleton delivery. The intramuscular injection is available in both single-dose and multidose vials.
Makena revenues in 2017 were nearly $400 million. The drug was the subject of a price controversy in 2011 under its maker at the time, KV Pharmaceutical, which subsequently cut the price by more than half.
The injection has several contraindications, including blood clots and hormone-sensitive cancers. Its efficacy is based on an improved number of women who used it and were delivered at more than 37 weeks’ gestation rather than on a directly demonstrated clinical benefit in neonatal morbidity or mortality.
Read more in AMAG’s press release.
Makena, a progestin injection for the prevention of preterm birth that has been approved for use since 2011, has received U.S. Food and Drug Administration approval for a subcutaneous auto-injection product to supplant its intramuscular injection formulation, announced its manufacturer, AMAG Pharmaceuticals, on Feb. 14.
The intramuscular injection’s 7-year orphan drug exclusivity expired earlier in February. AMAG plans to offer both products priced at parity, according to the company’s press release. The newer product has a smaller, thinner needle. Both products are intended for use in a woman who has a singleton pregnancy of less than 37 weeks’ gestation and who has had a prior spontaneous preterm singleton delivery. The intramuscular injection is available in both single-dose and multidose vials.
Makena revenues in 2017 were nearly $400 million. The drug was the subject of a price controversy in 2011 under its maker at the time, KV Pharmaceutical, which subsequently cut the price by more than half.
The injection has several contraindications, including blood clots and hormone-sensitive cancers. Its efficacy is based on an improved number of women who used it and were delivered at more than 37 weeks’ gestation rather than on a directly demonstrated clinical benefit in neonatal morbidity or mortality.
Read more in AMAG’s press release.
Makena, a progestin injection for the prevention of preterm birth that has been approved for use since 2011, has received U.S. Food and Drug Administration approval for a subcutaneous auto-injection product to supplant its intramuscular injection formulation, announced its manufacturer, AMAG Pharmaceuticals, on Feb. 14.
The intramuscular injection’s 7-year orphan drug exclusivity expired earlier in February. AMAG plans to offer both products priced at parity, according to the company’s press release. The newer product has a smaller, thinner needle. Both products are intended for use in a woman who has a singleton pregnancy of less than 37 weeks’ gestation and who has had a prior spontaneous preterm singleton delivery. The intramuscular injection is available in both single-dose and multidose vials.
Makena revenues in 2017 were nearly $400 million. The drug was the subject of a price controversy in 2011 under its maker at the time, KV Pharmaceutical, which subsequently cut the price by more than half.
The injection has several contraindications, including blood clots and hormone-sensitive cancers. Its efficacy is based on an improved number of women who used it and were delivered at more than 37 weeks’ gestation rather than on a directly demonstrated clinical benefit in neonatal morbidity or mortality.
Read more in AMAG’s press release.
Postcesarean SSI rate declines with care bundle*
DALLAS – A surgical site infection care bundle reduced the rate of surgical site infections (SSIs) after cesarean delivery by more than half, according to a case-control study examining data from more than 2,000 patients.
At the health center where the SSI bundle was implemented, rates per 1,000 women undergoing cesarean delivery fell from 2.44 to 1.10 (P = .013).
The study showed the effectiveness of implementing evidence-based and -supported recommendations, and of having standardized protocols with little variation, said Christina Davidson, MD, presenting the pre-post findings during a plenary session at the meeting sponsored by the Society for Maternal-Fetal Medicine.
The bundle of interventions was developed over the course of 3 months in late 2013 and early 2014 by a multidisciplinary task force, drawing from colorectal surgery literature about SSI prevention. Both nurses and physicians were on the task force, and representatives came from the departments of obstetrics and gynecology, anesthesia, and infection prevention, said Dr. Davidson of the Baylor College of Medicine, Houston. All inpatient and outpatient clinical care sites had representation.
After the bundle elements were identified, a full month was devoted to education and team training, with full bundle implementation occurring in April 2014. “Visual aids were placed in close proximity to the operating rooms,” said Dr. Davidson. For example, antimicrobial prophylaxis cards were placed on all anesthetic carts.
“A surgical checklist was placed in the chart for each patient undergoing cesarean delivery and compliance was tracked for the first 12 months of implementation,” said Dr. Davidson. Additionally, members of the care team received feedback in the form of quarterly reports on SSI rates and statistics about bundle compliance.
Care bundle elements included a set of instructions for pre- and postoperative antiseptic skin cleaning, wound care, and glycemic control in patients. Women were given chlorhexidine cleanser and asked to use it when showering the day before and the morning of surgery for planned deliveries. Forced warm-air blankets maintained patient normothermia in the preoperative holding area.
A group of intraoperative interventions included use of antiseptic skin and vaginal preparations, double-gloving, and having all scrubbed members of the surgical team change their outer gloves for fascial closure. A new instrument tray also was used for fascial closure. Prophylactic antibiotics were administered within 1 hour of skin incision, and doses were readministered based on the length of the procedure.
Postoperatively, said Dr. Davidson, “a set of insulin orders within the electronic medical record [was] used to maintain euglycemia in all diabetic patients.”
After the surgical dressing was removed on the 2nd postoperative day, patients were given a handout and education about wound control and infection prevention.
Finally, all patients received postdischarge follow-up calls from nurses within 72 hours after discharge.
Patient characteristics generally were similar before (n = 1,085) and after (n = 1,261) SSI bundle implementation. Body mass index was slightly higher in the postbundle group, and women in this group also were less likely to have had a prior cesarean delivery. There were no significant differences in age, gravidity, ethnicity, or race.
The study showed that with continued tracking, data-sharing, and reeducation efforts, “The SSI rate was sustained after bundle implementation,” said Dr. Davidson. The implementation team, working with hospital departments, was able to achieve a high compliance rate. And, she said, the effect size of the intervention was large enough to show significant reduction from an already low SSI rate.
However, Dr. Davidson also noted some limitations: All of the bundle elements were implemented simultaneously, so it wasn’t possible to tell which components had the greatest effect. Also, not all demographic data were available, and the type of SSI was sometimes unavailable from the deidentified data repository used for analysis, she said. “We weren’t able to tease out individual patient-level characteristics” about the timing and type of SSI in a patient-by-patient fashion, she said during discussion following her presentation.
All in all, she said, the bundle’s effectiveness “supports the synergistic effects of multiple strategies and the impact of a multidisciplinary team approach.”
The study authors reported no conflicts of interest.
SOURCE: Davidson C et al. Am J Obstet Gynecol. 2018 Jan;218:S46.
Correction, 3/5/18: An earlier version of this article omitted the word "rate" from the headline and Vitals section.
DALLAS – A surgical site infection care bundle reduced the rate of surgical site infections (SSIs) after cesarean delivery by more than half, according to a case-control study examining data from more than 2,000 patients.
At the health center where the SSI bundle was implemented, rates per 1,000 women undergoing cesarean delivery fell from 2.44 to 1.10 (P = .013).
The study showed the effectiveness of implementing evidence-based and -supported recommendations, and of having standardized protocols with little variation, said Christina Davidson, MD, presenting the pre-post findings during a plenary session at the meeting sponsored by the Society for Maternal-Fetal Medicine.
The bundle of interventions was developed over the course of 3 months in late 2013 and early 2014 by a multidisciplinary task force, drawing from colorectal surgery literature about SSI prevention. Both nurses and physicians were on the task force, and representatives came from the departments of obstetrics and gynecology, anesthesia, and infection prevention, said Dr. Davidson of the Baylor College of Medicine, Houston. All inpatient and outpatient clinical care sites had representation.
After the bundle elements were identified, a full month was devoted to education and team training, with full bundle implementation occurring in April 2014. “Visual aids were placed in close proximity to the operating rooms,” said Dr. Davidson. For example, antimicrobial prophylaxis cards were placed on all anesthetic carts.
“A surgical checklist was placed in the chart for each patient undergoing cesarean delivery and compliance was tracked for the first 12 months of implementation,” said Dr. Davidson. Additionally, members of the care team received feedback in the form of quarterly reports on SSI rates and statistics about bundle compliance.
Care bundle elements included a set of instructions for pre- and postoperative antiseptic skin cleaning, wound care, and glycemic control in patients. Women were given chlorhexidine cleanser and asked to use it when showering the day before and the morning of surgery for planned deliveries. Forced warm-air blankets maintained patient normothermia in the preoperative holding area.
A group of intraoperative interventions included use of antiseptic skin and vaginal preparations, double-gloving, and having all scrubbed members of the surgical team change their outer gloves for fascial closure. A new instrument tray also was used for fascial closure. Prophylactic antibiotics were administered within 1 hour of skin incision, and doses were readministered based on the length of the procedure.
Postoperatively, said Dr. Davidson, “a set of insulin orders within the electronic medical record [was] used to maintain euglycemia in all diabetic patients.”
After the surgical dressing was removed on the 2nd postoperative day, patients were given a handout and education about wound control and infection prevention.
Finally, all patients received postdischarge follow-up calls from nurses within 72 hours after discharge.
Patient characteristics generally were similar before (n = 1,085) and after (n = 1,261) SSI bundle implementation. Body mass index was slightly higher in the postbundle group, and women in this group also were less likely to have had a prior cesarean delivery. There were no significant differences in age, gravidity, ethnicity, or race.
The study showed that with continued tracking, data-sharing, and reeducation efforts, “The SSI rate was sustained after bundle implementation,” said Dr. Davidson. The implementation team, working with hospital departments, was able to achieve a high compliance rate. And, she said, the effect size of the intervention was large enough to show significant reduction from an already low SSI rate.
However, Dr. Davidson also noted some limitations: All of the bundle elements were implemented simultaneously, so it wasn’t possible to tell which components had the greatest effect. Also, not all demographic data were available, and the type of SSI was sometimes unavailable from the deidentified data repository used for analysis, she said. “We weren’t able to tease out individual patient-level characteristics” about the timing and type of SSI in a patient-by-patient fashion, she said during discussion following her presentation.
All in all, she said, the bundle’s effectiveness “supports the synergistic effects of multiple strategies and the impact of a multidisciplinary team approach.”
The study authors reported no conflicts of interest.
SOURCE: Davidson C et al. Am J Obstet Gynecol. 2018 Jan;218:S46.
Correction, 3/5/18: An earlier version of this article omitted the word "rate" from the headline and Vitals section.
DALLAS – A surgical site infection care bundle reduced the rate of surgical site infections (SSIs) after cesarean delivery by more than half, according to a case-control study examining data from more than 2,000 patients.
At the health center where the SSI bundle was implemented, rates per 1,000 women undergoing cesarean delivery fell from 2.44 to 1.10 (P = .013).
The study showed the effectiveness of implementing evidence-based and -supported recommendations, and of having standardized protocols with little variation, said Christina Davidson, MD, presenting the pre-post findings during a plenary session at the meeting sponsored by the Society for Maternal-Fetal Medicine.
The bundle of interventions was developed over the course of 3 months in late 2013 and early 2014 by a multidisciplinary task force, drawing from colorectal surgery literature about SSI prevention. Both nurses and physicians were on the task force, and representatives came from the departments of obstetrics and gynecology, anesthesia, and infection prevention, said Dr. Davidson of the Baylor College of Medicine, Houston. All inpatient and outpatient clinical care sites had representation.
After the bundle elements were identified, a full month was devoted to education and team training, with full bundle implementation occurring in April 2014. “Visual aids were placed in close proximity to the operating rooms,” said Dr. Davidson. For example, antimicrobial prophylaxis cards were placed on all anesthetic carts.
“A surgical checklist was placed in the chart for each patient undergoing cesarean delivery and compliance was tracked for the first 12 months of implementation,” said Dr. Davidson. Additionally, members of the care team received feedback in the form of quarterly reports on SSI rates and statistics about bundle compliance.
Care bundle elements included a set of instructions for pre- and postoperative antiseptic skin cleaning, wound care, and glycemic control in patients. Women were given chlorhexidine cleanser and asked to use it when showering the day before and the morning of surgery for planned deliveries. Forced warm-air blankets maintained patient normothermia in the preoperative holding area.
A group of intraoperative interventions included use of antiseptic skin and vaginal preparations, double-gloving, and having all scrubbed members of the surgical team change their outer gloves for fascial closure. A new instrument tray also was used for fascial closure. Prophylactic antibiotics were administered within 1 hour of skin incision, and doses were readministered based on the length of the procedure.
Postoperatively, said Dr. Davidson, “a set of insulin orders within the electronic medical record [was] used to maintain euglycemia in all diabetic patients.”
After the surgical dressing was removed on the 2nd postoperative day, patients were given a handout and education about wound control and infection prevention.
Finally, all patients received postdischarge follow-up calls from nurses within 72 hours after discharge.
Patient characteristics generally were similar before (n = 1,085) and after (n = 1,261) SSI bundle implementation. Body mass index was slightly higher in the postbundle group, and women in this group also were less likely to have had a prior cesarean delivery. There were no significant differences in age, gravidity, ethnicity, or race.
The study showed that with continued tracking, data-sharing, and reeducation efforts, “The SSI rate was sustained after bundle implementation,” said Dr. Davidson. The implementation team, working with hospital departments, was able to achieve a high compliance rate. And, she said, the effect size of the intervention was large enough to show significant reduction from an already low SSI rate.
However, Dr. Davidson also noted some limitations: All of the bundle elements were implemented simultaneously, so it wasn’t possible to tell which components had the greatest effect. Also, not all demographic data were available, and the type of SSI was sometimes unavailable from the deidentified data repository used for analysis, she said. “We weren’t able to tease out individual patient-level characteristics” about the timing and type of SSI in a patient-by-patient fashion, she said during discussion following her presentation.
All in all, she said, the bundle’s effectiveness “supports the synergistic effects of multiple strategies and the impact of a multidisciplinary team approach.”
The study authors reported no conflicts of interest.
SOURCE: Davidson C et al. Am J Obstet Gynecol. 2018 Jan;218:S46.
Correction, 3/5/18: An earlier version of this article omitted the word "rate" from the headline and Vitals section.
REPORTING FROM THE PREGNANCY MEETING
Key clinical point: The postcesarean surgical site infection rate dropped by more than half after a multicomponent care bundle was put in place.*
Major finding: SSIs patients went from 2.44 to 1.10/1,000 after the bundle was implemented (P = .013).
Study details: Case-control study of 1,085 women pre– and 1,261 women post–care bundle implementation.
Disclosures: The authors reported no conflicts of interest.
Source: Davidson C et al. Am J Obstet Gynecol. 2018 Jan;218:S46.