OBG Management

EXPERT COMMENTARY

Vinogradova Y, Coupland C, Hippisley-Cox J. Use of hormone replacement therapy and risk of venous thromboembolism: nested case-control studies using the QResearch and CPRD databases. BMJ. 2019;364:k4810.

The Women’s Health Initiative trials, in which menopausal women were randomly assigned to treatment with oral CEE or placebo, found that statistically the largest risk associated with menopausal hormone therapy (HT) was increased VTE.¹ Recently, investigators in the United Kingdom (UK) published results of their research aimed at determining the association between the risk of VTE and the use of different types of HT.²

Details of the study

Vinogradova and colleagues used 2 UK primary care research databases, QResearch and Clinical Practice Research Datalink, to identify cases of incident VTE in general practice records, hospital admissions, and mortality records. They identified 80,396 women (aged 40 to 79 years) diagnosed with VTE between 1998 and 2017 and 391,494 control women matched by age and general practice. The mean age of the case and control women was approximately 64 years; the great majority of women were white. Analyses were adjusted for smoking, body mass index (BMI), family history of VTE, and comorbidities associated with VTE.

Types of HT used. The investigators found that 5,795 (7.2%) women with VTE and 21,670 (5.5%) controls were exposed to HT in the 90 days before the index date (the first date of VTE diagnosis for cases became the index date for matched controls). In those exposed to HT:

• 4,915 (85%) cases and 16,938 (78%) controls used oral preparations (including 102 [1.8%] cases and 312 [1.4%] controls who also had transdermal preparations)
• 880 (14%) cases and 4,731 (19%) controls used transdermal HT only.

Association of VTE with HT. Risk of VTE was increased with all oral HT formulations, including combined (estrogen plus progestogen) and estrogen-only preparations. Use of oral CEE (odds ratio [OR], 1.49) and estradiol (OR, 1.27) were both associated with an elevated risk of VTE (P<.05 for both comparisons). In contrast, use of transdermal estradiol (the great majority of which was administered by patch) was not associated with an elevated risk of VTE (OR, 0.96).

Direct comparison of oral estradiol and CEE found that the lower VTE risk with oral estradiol achieved statistical significance (P = .005). Direct comparison of oral and transdermal estrogen revealed an OR of 1.7 for the oral route of administration (P<.001)

Continue to: Study strengths and weaknesses

Study strengths and weaknesses

This study used data from the 2 largest primary care databases in the United Kingdom. Analyses were adjusted for numerous confounding factors, including acute and chronic conditions, lifestyle factors, and social deprivation. Additional sensitivity analyses were conducted and yielded results similar to those of the main analysis.

Several limitations could have resulted in some residual confounding bias. For example, drug exposure information was based on HT prescriptions and not actual use; data on some factors were not available, such as indications for HT, age at menopause, and education level; and for a small proportion of women, some data (smoking status, alcohol consumption, BMI) were missing and had to be imputed for analysis.

EXPERT COMMENTARY

Vinogradova Y, Coupland C, Hippisley-Cox J. Use of hormone replacement therapy and risk of venous thromboembolism: nested case-control studies using the QResearch and CPRD databases. BMJ. 2019;364:k4810.

The Women’s Health Initiative trials, in which menopausal women were randomly assigned to treatment with oral CEE or placebo, found that statistically the largest risk associated with menopausal hormone therapy (HT) was increased VTE.¹ Recently, investigators in the United Kingdom (UK) published results of their research aimed at determining the association between the risk of VTE and the use of different types of HT.²

Details of the study

Vinogradova and colleagues used 2 UK primary care research databases, QResearch and Clinical Practice Research Datalink, to identify cases of incident VTE in general practice records, hospital admissions, and mortality records. They identified 80,396 women (aged 40 to 79 years) diagnosed with VTE between 1998 and 2017 and 391,494 control women matched by age and general practice. The mean age of the case and control women was approximately 64 years; the great majority of women were white. Analyses were adjusted for smoking, body mass index (BMI), family history of VTE, and comorbidities associated with VTE.

Types of HT used. The investigators found that 5,795 (7.2%) women with VTE and 21,670 (5.5%) controls were exposed to HT in the 90 days before the index date (the first date of VTE diagnosis for cases became the index date for matched controls). In those exposed to HT:

• 4,915 (85%) cases and 16,938 (78%) controls used oral preparations (including 102 [1.8%] cases and 312 [1.4%] controls who also had transdermal preparations)
• 880 (14%) cases and 4,731 (19%) controls used transdermal HT only.

Association of VTE with HT. Risk of VTE was increased with all oral HT formulations, including combined (estrogen plus progestogen) and estrogen-only preparations. Use of oral CEE (odds ratio [OR], 1.49) and estradiol (OR, 1.27) were both associated with an elevated risk of VTE (P<.05 for both comparisons). In contrast, use of transdermal estradiol (the great majority of which was administered by patch) was not associated with an elevated risk of VTE (OR, 0.96).

Direct comparison of oral estradiol and CEE found that the lower VTE risk with oral estradiol achieved statistical significance (P = .005). Direct comparison of oral and transdermal estrogen revealed an OR of 1.7 for the oral route of administration (P<.001)

Continue to: Study strengths and weaknesses

Study strengths and weaknesses

This study used data from the 2 largest primary care databases in the United Kingdom. Analyses were adjusted for numerous confounding factors, including acute and chronic conditions, lifestyle factors, and social deprivation. Additional sensitivity analyses were conducted and yielded results similar to those of the main analysis.

Several limitations could have resulted in some residual confounding bias. For example, drug exposure information was based on HT prescriptions and not actual use; data on some factors were not available, such as indications for HT, age at menopause, and education level; and for a small proportion of women, some data (smoking status, alcohol consumption, BMI) were missing and had to be imputed for analysis.

EXPERT COMMENTARY

Vinogradova Y, Coupland C, Hippisley-Cox J. Use of hormone replacement therapy and risk of venous thromboembolism: nested case-control studies using the QResearch and CPRD databases. BMJ. 2019;364:k4810.

The Women’s Health Initiative trials, in which menopausal women were randomly assigned to treatment with oral CEE or placebo, found that statistically the largest risk associated with menopausal hormone therapy (HT) was increased VTE.¹ Recently, investigators in the United Kingdom (UK) published results of their research aimed at determining the association between the risk of VTE and the use of different types of HT.²

Details of the study

Vinogradova and colleagues used 2 UK primary care research databases, QResearch and Clinical Practice Research Datalink, to identify cases of incident VTE in general practice records, hospital admissions, and mortality records. They identified 80,396 women (aged 40 to 79 years) diagnosed with VTE between 1998 and 2017 and 391,494 control women matched by age and general practice. The mean age of the case and control women was approximately 64 years; the great majority of women were white. Analyses were adjusted for smoking, body mass index (BMI), family history of VTE, and comorbidities associated with VTE.

Types of HT used. The investigators found that 5,795 (7.2%) women with VTE and 21,670 (5.5%) controls were exposed to HT in the 90 days before the index date (the first date of VTE diagnosis for cases became the index date for matched controls). In those exposed to HT:

• 4,915 (85%) cases and 16,938 (78%) controls used oral preparations (including 102 [1.8%] cases and 312 [1.4%] controls who also had transdermal preparations)
• 880 (14%) cases and 4,731 (19%) controls used transdermal HT only.

Association of VTE with HT. Risk of VTE was increased with all oral HT formulations, including combined (estrogen plus progestogen) and estrogen-only preparations. Use of oral CEE (odds ratio [OR], 1.49) and estradiol (OR, 1.27) were both associated with an elevated risk of VTE (P<.05 for both comparisons). In contrast, use of transdermal estradiol (the great majority of which was administered by patch) was not associated with an elevated risk of VTE (OR, 0.96).

Direct comparison of oral estradiol and CEE found that the lower VTE risk with oral estradiol achieved statistical significance (P = .005). Direct comparison of oral and transdermal estrogen revealed an OR of 1.7 for the oral route of administration (P<.001)

Continue to: Study strengths and weaknesses

Study strengths and weaknesses

This study used data from the 2 largest primary care databases in the United Kingdom. Analyses were adjusted for numerous confounding factors, including acute and chronic conditions, lifestyle factors, and social deprivation. Additional sensitivity analyses were conducted and yielded results similar to those of the main analysis.

Several limitations could have resulted in some residual confounding bias. For example, drug exposure information was based on HT prescriptions and not actual use; data on some factors were not available, such as indications for HT, age at menopause, and education level; and for a small proportion of women, some data (smoking status, alcohol consumption, BMI) were missing and had to be imputed for analysis.

Click here to read the supplement. 

Iron deficiency anemia (IDA) is one of the most common causes of anemia in women, and affects women of all ages. In this supplement, you will read about:

• How to identify IDA in women
• How to treat IDA
• A patient case study

Click here to read the supplement. 

Click here to read the supplement. 

Iron deficiency anemia (IDA) is one of the most common causes of anemia in women, and affects women of all ages. In this supplement, you will read about:

• How to identify IDA in women
• How to treat IDA
• A patient case study

Click here to read the supplement. 

Click here to read the supplement. 

Iron deficiency anemia (IDA) is one of the most common causes of anemia in women, and affects women of all ages. In this supplement, you will read about:

• How to identify IDA in women
• How to treat IDA
• A patient case study

Click here to read the supplement. 

PREIMPLANTATION GENETIC TESTING

In a retrospective study published in Fertility and Sterility, Spectrum, a single-nucleotide polymorphism (SNP)-based PGT-A technology, was successful in screening all 24 chromosomes to provide comprehensive embryo aneuploidy results. Natera says that the study results showed that use of Spectrum PGT-A during IVF led to excellent implantation (70%), clinical pregnancy (71%), and live birth (65%) rates during single embryo transfer.

Spectrum evaluates the number of chromosomes in embryos to detect extra or missing chromosomes and screens for inherited genetic disorders to help provide the best chance of transferring a healthy embryo with the correct number of chromosomes.

FOR MORE INFORMATION, VISIT: https://www.natera.com/spectrum
 

PORTABLE BREAST ULTRASOUND

Viera is a wireless, handheld breast ultrasound scanner that Hologic says produces exceptional image quality. The scanner uses a 14-4 MHz linear transducer, contains 192 elements, and has 4 parallel software beamformers. It utilizes spatial compounding to reduce image noise and speckle. Presets are available for breast, dense breast, and interventional procedures with B, M, power Doppler, color Doppler, and needle enhancement modes. On-demand high-resolution images are transmitted wirelessly to smart devices and patient archive systems (PACS) in the office, exam room, or surgical suite, or to the Cloud for efficient documentation. Smart device platforms include iOS and Android devices using WiFi and Bluetooth connectivity. The system includes a 1.2-lb scanner, 2 rechargeable batteries, and a charger with global AC adapter.

FOR MORE INFORMATION, VISIT: https://www.vieraportableultrasound.com

HOME SPERM TEST

The customer downloads the smart-phone app and acquires the YO Kit. After collecting a semen sample, he uses a pipette from the kit to place semen on a slide, which is slipped into the Yo Clip. The clip slides onto the smartphone, which uses its camera to take a high-resolution video. Test results and the sperm video appear in about 2 minutes.

At $59.95, the YO Kit includes 2 tests, in case a second sample is desired.

FOR MORE INFORMATION, VISIT:

https://www.yospermtest.com
 

Continue to Improving the Mammography Experience…

IMPROVING THE MAMMOGRAPHY EXPERIENCE

SmartCurve is standard on Hologic’s new 3Dimensions™ mammography system and as an enhancement option to existing Hologic Selenia^®Dimensions^® systems.

FOR MORE INFORMATION, VISIT:https://www.smartcurvesystem.com

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.

PREIMPLANTATION GENETIC TESTING

In a retrospective study published in Fertility and Sterility, Spectrum, a single-nucleotide polymorphism (SNP)-based PGT-A technology, was successful in screening all 24 chromosomes to provide comprehensive embryo aneuploidy results. Natera says that the study results showed that use of Spectrum PGT-A during IVF led to excellent implantation (70%), clinical pregnancy (71%), and live birth (65%) rates during single embryo transfer.

Spectrum evaluates the number of chromosomes in embryos to detect extra or missing chromosomes and screens for inherited genetic disorders to help provide the best chance of transferring a healthy embryo with the correct number of chromosomes.

FOR MORE INFORMATION, VISIT: https://www.natera.com/spectrum
 

PORTABLE BREAST ULTRASOUND

Viera is a wireless, handheld breast ultrasound scanner that Hologic says produces exceptional image quality. The scanner uses a 14-4 MHz linear transducer, contains 192 elements, and has 4 parallel software beamformers. It utilizes spatial compounding to reduce image noise and speckle. Presets are available for breast, dense breast, and interventional procedures with B, M, power Doppler, color Doppler, and needle enhancement modes. On-demand high-resolution images are transmitted wirelessly to smart devices and patient archive systems (PACS) in the office, exam room, or surgical suite, or to the Cloud for efficient documentation. Smart device platforms include iOS and Android devices using WiFi and Bluetooth connectivity. The system includes a 1.2-lb scanner, 2 rechargeable batteries, and a charger with global AC adapter.

FOR MORE INFORMATION, VISIT: https://www.vieraportableultrasound.com

HOME SPERM TEST

The customer downloads the smart-phone app and acquires the YO Kit. After collecting a semen sample, he uses a pipette from the kit to place semen on a slide, which is slipped into the Yo Clip. The clip slides onto the smartphone, which uses its camera to take a high-resolution video. Test results and the sperm video appear in about 2 minutes.

At $59.95, the YO Kit includes 2 tests, in case a second sample is desired.

FOR MORE INFORMATION, VISIT:

https://www.yospermtest.com
 

Continue to Improving the Mammography Experience…

IMPROVING THE MAMMOGRAPHY EXPERIENCE

SmartCurve is standard on Hologic’s new 3Dimensions™ mammography system and as an enhancement option to existing Hologic Selenia^®Dimensions^® systems.

FOR MORE INFORMATION, VISIT:https://www.smartcurvesystem.com

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.

PREIMPLANTATION GENETIC TESTING

In a retrospective study published in Fertility and Sterility, Spectrum, a single-nucleotide polymorphism (SNP)-based PGT-A technology, was successful in screening all 24 chromosomes to provide comprehensive embryo aneuploidy results. Natera says that the study results showed that use of Spectrum PGT-A during IVF led to excellent implantation (70%), clinical pregnancy (71%), and live birth (65%) rates during single embryo transfer.

Spectrum evaluates the number of chromosomes in embryos to detect extra or missing chromosomes and screens for inherited genetic disorders to help provide the best chance of transferring a healthy embryo with the correct number of chromosomes.

FOR MORE INFORMATION, VISIT: https://www.natera.com/spectrum
 

PORTABLE BREAST ULTRASOUND

Viera is a wireless, handheld breast ultrasound scanner that Hologic says produces exceptional image quality. The scanner uses a 14-4 MHz linear transducer, contains 192 elements, and has 4 parallel software beamformers. It utilizes spatial compounding to reduce image noise and speckle. Presets are available for breast, dense breast, and interventional procedures with B, M, power Doppler, color Doppler, and needle enhancement modes. On-demand high-resolution images are transmitted wirelessly to smart devices and patient archive systems (PACS) in the office, exam room, or surgical suite, or to the Cloud for efficient documentation. Smart device platforms include iOS and Android devices using WiFi and Bluetooth connectivity. The system includes a 1.2-lb scanner, 2 rechargeable batteries, and a charger with global AC adapter.

FOR MORE INFORMATION, VISIT: https://www.vieraportableultrasound.com

HOME SPERM TEST

The customer downloads the smart-phone app and acquires the YO Kit. After collecting a semen sample, he uses a pipette from the kit to place semen on a slide, which is slipped into the Yo Clip. The clip slides onto the smartphone, which uses its camera to take a high-resolution video. Test results and the sperm video appear in about 2 minutes.

At $59.95, the YO Kit includes 2 tests, in case a second sample is desired.

FOR MORE INFORMATION, VISIT:

https://www.yospermtest.com
 

Continue to Improving the Mammography Experience…

IMPROVING THE MAMMOGRAPHY EXPERIENCE

SmartCurve is standard on Hologic’s new 3Dimensions™ mammography system and as an enhancement option to existing Hologic Selenia^®Dimensions^® systems.

FOR MORE INFORMATION, VISIT:https://www.smartcurvesystem.com

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.

On the afternoon of November 19, 2018, Dr. Tamara O’Neal was shot and killed by her ex-fiancé outside Mercy Hospital and Medical Center in Chicago, Illinois. After killing Dr. O’Neal, the gunman ran into the hospital where he exchanged gunfire with police, killing a pharmacy resident and a police officer, before he was killed by police.¹

This horrific encounter between a woman and her former partner begs for a conversation about intimate partner violence (IPV). A data brief of The National Intimate Partner and Sexual Violence Survey was published in November 2018. According to this report, 30.6% of women experienced physical violence by an intimate partner in 2015, with 21.4% of women experiencing severe physical violence. In addition, 31.0% of men experienced physical violence by an intimate partner in 2015; 14.9% of men experienced severe physical violence.²

Intimate partner violence is “our lane”

The shooting at Mercy Hospital occurred amongst a backdrop of controversy between the National Rifle Association (NRA) and the medical community. On November 7, 2018, the NRA tweeted that doctors should “stay in their lane” with regard to gun control after a position paper from the American College of Physicians on reducing firearm deaths and injuries was published in the Annals of Internal Medicine.³ Doctors from every field and from all over the country responded through social media by stating that treating bullet wounds and caring for those affected by gun violence was “their lane.”⁴

It is time for us as a community to recognize that gun violence affects us all. The majority of mass shooters have a history of IPV and often target their current or prior partner during the shooting.⁵ At this intersection of IPV and gun control, the physician has a unique role. We not only treat those affected by gun violence and advocate for better gun control but we also have a duty to screen our patients for IPV. Part of the sacred patient-physician relationship is being present for our patients when they need us most. The American College of Obstetricians and Gynecologists (ACOG) recommends that ObGyns screen patients for IPV at regular intervals and recognizes that it may take several conversations before a patient discloses her history of IPV.⁶ Additionally, given the increased risk of gun injuries and death, it behooves us to also screen for gun safety in the home.

Ask patients about IPV, and ask again

The shooting at Mercy Hospital was a stark reminder that IPV can affect any of us. With nearly one-third of women and more than one-quarter of men experiencing IPV in their lifetime, action must be taken. The first step is to routinely screen patients for IPV, offering support and community resources. (see “Screening for intimate partner violence). The second step is to work to decrease the access perpetrators of IPV have to weapons with which to enact violence—through legislation, community engagement, and using our physician voices.

States that have passed legislation that prohibits persons with active restraining orders or a history of IPV or domestic violence from possessing firearms has seen a decrease in IPV firearm homicide rates.⁷ These policies can make a profound impact on the safety of our patients. Women who are in violent relationships are 5 times more likely to die if their partner has access to a firearm.⁵

Continue to: #BreakTheCycle...

#BreakTheCycle

The 116th Congress convened in January. We have an opportunity to make real gun legislation reform and work to keep our communities and our patients at risk for IPV safer. Tweet your representatives with #BreakTheCycle, and be on the lookout for important legislation to enact real change.

To sign the open letter from American Healthcare Professionals to the NRA regarding their recent comments and our medical experiences with gun violence, click here. Currently, there are more than 41,000 signatures.

If you, or someone you know, needs help, please call The National Domestic Violence Hotline at 1-800-799-7233.

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.

On the afternoon of November 19, 2018, Dr. Tamara O’Neal was shot and killed by her ex-fiancé outside Mercy Hospital and Medical Center in Chicago, Illinois. After killing Dr. O’Neal, the gunman ran into the hospital where he exchanged gunfire with police, killing a pharmacy resident and a police officer, before he was killed by police.¹

This horrific encounter between a woman and her former partner begs for a conversation about intimate partner violence (IPV). A data brief of The National Intimate Partner and Sexual Violence Survey was published in November 2018. According to this report, 30.6% of women experienced physical violence by an intimate partner in 2015, with 21.4% of women experiencing severe physical violence. In addition, 31.0% of men experienced physical violence by an intimate partner in 2015; 14.9% of men experienced severe physical violence.²

Intimate partner violence is “our lane”

The shooting at Mercy Hospital occurred amongst a backdrop of controversy between the National Rifle Association (NRA) and the medical community. On November 7, 2018, the NRA tweeted that doctors should “stay in their lane” with regard to gun control after a position paper from the American College of Physicians on reducing firearm deaths and injuries was published in the Annals of Internal Medicine.³ Doctors from every field and from all over the country responded through social media by stating that treating bullet wounds and caring for those affected by gun violence was “their lane.”⁴

It is time for us as a community to recognize that gun violence affects us all. The majority of mass shooters have a history of IPV and often target their current or prior partner during the shooting.⁵ At this intersection of IPV and gun control, the physician has a unique role. We not only treat those affected by gun violence and advocate for better gun control but we also have a duty to screen our patients for IPV. Part of the sacred patient-physician relationship is being present for our patients when they need us most. The American College of Obstetricians and Gynecologists (ACOG) recommends that ObGyns screen patients for IPV at regular intervals and recognizes that it may take several conversations before a patient discloses her history of IPV.⁶ Additionally, given the increased risk of gun injuries and death, it behooves us to also screen for gun safety in the home.

Ask patients about IPV, and ask again

The shooting at Mercy Hospital was a stark reminder that IPV can affect any of us. With nearly one-third of women and more than one-quarter of men experiencing IPV in their lifetime, action must be taken. The first step is to routinely screen patients for IPV, offering support and community resources. (see “Screening for intimate partner violence). The second step is to work to decrease the access perpetrators of IPV have to weapons with which to enact violence—through legislation, community engagement, and using our physician voices.

States that have passed legislation that prohibits persons with active restraining orders or a history of IPV or domestic violence from possessing firearms has seen a decrease in IPV firearm homicide rates.⁷ These policies can make a profound impact on the safety of our patients. Women who are in violent relationships are 5 times more likely to die if their partner has access to a firearm.⁵

Continue to: #BreakTheCycle...

#BreakTheCycle

The 116th Congress convened in January. We have an opportunity to make real gun legislation reform and work to keep our communities and our patients at risk for IPV safer. Tweet your representatives with #BreakTheCycle, and be on the lookout for important legislation to enact real change.

To sign the open letter from American Healthcare Professionals to the NRA regarding their recent comments and our medical experiences with gun violence, click here. Currently, there are more than 41,000 signatures.

If you, or someone you know, needs help, please call The National Domestic Violence Hotline at 1-800-799-7233.

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.

On the afternoon of November 19, 2018, Dr. Tamara O’Neal was shot and killed by her ex-fiancé outside Mercy Hospital and Medical Center in Chicago, Illinois. After killing Dr. O’Neal, the gunman ran into the hospital where he exchanged gunfire with police, killing a pharmacy resident and a police officer, before he was killed by police.¹

This horrific encounter between a woman and her former partner begs for a conversation about intimate partner violence (IPV). A data brief of The National Intimate Partner and Sexual Violence Survey was published in November 2018. According to this report, 30.6% of women experienced physical violence by an intimate partner in 2015, with 21.4% of women experiencing severe physical violence. In addition, 31.0% of men experienced physical violence by an intimate partner in 2015; 14.9% of men experienced severe physical violence.²

Intimate partner violence is “our lane”

The shooting at Mercy Hospital occurred amongst a backdrop of controversy between the National Rifle Association (NRA) and the medical community. On November 7, 2018, the NRA tweeted that doctors should “stay in their lane” with regard to gun control after a position paper from the American College of Physicians on reducing firearm deaths and injuries was published in the Annals of Internal Medicine.³ Doctors from every field and from all over the country responded through social media by stating that treating bullet wounds and caring for those affected by gun violence was “their lane.”⁴

It is time for us as a community to recognize that gun violence affects us all. The majority of mass shooters have a history of IPV and often target their current or prior partner during the shooting.⁵ At this intersection of IPV and gun control, the physician has a unique role. We not only treat those affected by gun violence and advocate for better gun control but we also have a duty to screen our patients for IPV. Part of the sacred patient-physician relationship is being present for our patients when they need us most. The American College of Obstetricians and Gynecologists (ACOG) recommends that ObGyns screen patients for IPV at regular intervals and recognizes that it may take several conversations before a patient discloses her history of IPV.⁶ Additionally, given the increased risk of gun injuries and death, it behooves us to also screen for gun safety in the home.

Ask patients about IPV, and ask again

The shooting at Mercy Hospital was a stark reminder that IPV can affect any of us. With nearly one-third of women and more than one-quarter of men experiencing IPV in their lifetime, action must be taken. The first step is to routinely screen patients for IPV, offering support and community resources. (see “Screening for intimate partner violence). The second step is to work to decrease the access perpetrators of IPV have to weapons with which to enact violence—through legislation, community engagement, and using our physician voices.

States that have passed legislation that prohibits persons with active restraining orders or a history of IPV or domestic violence from possessing firearms has seen a decrease in IPV firearm homicide rates.⁷ These policies can make a profound impact on the safety of our patients. Women who are in violent relationships are 5 times more likely to die if their partner has access to a firearm.⁵

Continue to: #BreakTheCycle...

#BreakTheCycle

The 116th Congress convened in January. We have an opportunity to make real gun legislation reform and work to keep our communities and our patients at risk for IPV safer. Tweet your representatives with #BreakTheCycle, and be on the lookout for important legislation to enact real change.

To sign the open letter from American Healthcare Professionals to the NRA regarding their recent comments and our medical experiences with gun violence, click here. Currently, there are more than 41,000 signatures.

If you, or someone you know, needs help, please call The National Domestic Violence Hotline at 1-800-799-7233.

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.

To determine if a nationwide implementation of robotic minimally invasive surgery (MIS) influenced the risk of severe complications and survival among women with early-stage endometrial cancer, a group of researchers from the University of Southern Denmark studied the Danish Gynecological Cancer Database, a nationwide, mandatory prospective registration of new cases of women with endometrial cancer who received their surgical treatment in a public hospital.¹ Siv Joergensen, MD, reported results at the 47th AAGL Global Congress on Minimally Invasive Gynecology annual meeting on November 13, 2018, in Las Vegas, Nevada.

The transition to robotic MIS was undertaken in Denmark from 2008 to 2013, with the centralization of endometrial cancer treatment in 2012. Over the span of 10 years, the surgical approach to treatment changed from 97% open access surgery to 95% MIS.

For the prospective cohort study, more than 7,000 women with endometrial cancer who received a hysterectomy from January 2005 to June 2015 were grouped by those receiving surgical care before (group 1) and after (group 2) robotic MIS implementation in Denmark. A total of 5,654 women with FIGO Stage I–II endometrial cancer were included in the final study.

Severe complications were 7.3% in group 1 and 6.2% in group 2 (odds ratio, 1.38; 95% confidence interval [CI], 1.10–1.73). Five-year survival rates were significantly lower before robotic MIS was implemented (hazard ratio, 1.22; 95% CI, 1.05–1.41), and no difference was found between laparoscopic and robotic MIS.

The authors concluded that nationwide implementation of robotic MIS enabled a shift toward all types of MIS (with a 73% reduction in hysterectomies performed by laparotomy) and translated into reduced risk of severe complications and increased survival.

How do these results compare with those in the United States?

According to Erica Dun, MD, MPH, who provided commentary for Dr. Joergensen’s study, the United States adopted robotic MIS in the early 2000s. Around 2008, 14% of hysterectomies performed for early-stage endometrial cancer were done through a MIS approach.² In 2014, after a study in which Walker and colleagues found that laparoscopy was safe and feasible compared with laparotomy,³ the American College of Obstetricians and Gynecologists, jointly with the Society of Gynecologic Oncologists, stated that “MIS should be embraced as the standard surgical approach for comprehensive surgical staging in women with endometrial cancer.”⁴

Dr. Dun pointed out that Casarin and colleagues found in 2018 that 71.4% of surgeries performed in the United States for endometrial cancer were performed through MIS.⁵ That number rose to 86.5% MIS (72.5% robot-assisted) for centers of the National Comprehensive Cancer Network.⁶

Dr. Dun concluded that nationwide implementation of robotic MIS is feasible for gynecologic oncologists, and it is beneficial for patients.

To determine if a nationwide implementation of robotic minimally invasive surgery (MIS) influenced the risk of severe complications and survival among women with early-stage endometrial cancer, a group of researchers from the University of Southern Denmark studied the Danish Gynecological Cancer Database, a nationwide, mandatory prospective registration of new cases of women with endometrial cancer who received their surgical treatment in a public hospital.¹ Siv Joergensen, MD, reported results at the 47th AAGL Global Congress on Minimally Invasive Gynecology annual meeting on November 13, 2018, in Las Vegas, Nevada.

The transition to robotic MIS was undertaken in Denmark from 2008 to 2013, with the centralization of endometrial cancer treatment in 2012. Over the span of 10 years, the surgical approach to treatment changed from 97% open access surgery to 95% MIS.

For the prospective cohort study, more than 7,000 women with endometrial cancer who received a hysterectomy from January 2005 to June 2015 were grouped by those receiving surgical care before (group 1) and after (group 2) robotic MIS implementation in Denmark. A total of 5,654 women with FIGO Stage I–II endometrial cancer were included in the final study.

Severe complications were 7.3% in group 1 and 6.2% in group 2 (odds ratio, 1.38; 95% confidence interval [CI], 1.10–1.73). Five-year survival rates were significantly lower before robotic MIS was implemented (hazard ratio, 1.22; 95% CI, 1.05–1.41), and no difference was found between laparoscopic and robotic MIS.

The authors concluded that nationwide implementation of robotic MIS enabled a shift toward all types of MIS (with a 73% reduction in hysterectomies performed by laparotomy) and translated into reduced risk of severe complications and increased survival.

How do these results compare with those in the United States?

According to Erica Dun, MD, MPH, who provided commentary for Dr. Joergensen’s study, the United States adopted robotic MIS in the early 2000s. Around 2008, 14% of hysterectomies performed for early-stage endometrial cancer were done through a MIS approach.² In 2014, after a study in which Walker and colleagues found that laparoscopy was safe and feasible compared with laparotomy,³ the American College of Obstetricians and Gynecologists, jointly with the Society of Gynecologic Oncologists, stated that “MIS should be embraced as the standard surgical approach for comprehensive surgical staging in women with endometrial cancer.”⁴

Dr. Dun pointed out that Casarin and colleagues found in 2018 that 71.4% of surgeries performed in the United States for endometrial cancer were performed through MIS.⁵ That number rose to 86.5% MIS (72.5% robot-assisted) for centers of the National Comprehensive Cancer Network.⁶

Dr. Dun concluded that nationwide implementation of robotic MIS is feasible for gynecologic oncologists, and it is beneficial for patients.

To determine if a nationwide implementation of robotic minimally invasive surgery (MIS) influenced the risk of severe complications and survival among women with early-stage endometrial cancer, a group of researchers from the University of Southern Denmark studied the Danish Gynecological Cancer Database, a nationwide, mandatory prospective registration of new cases of women with endometrial cancer who received their surgical treatment in a public hospital.¹ Siv Joergensen, MD, reported results at the 47th AAGL Global Congress on Minimally Invasive Gynecology annual meeting on November 13, 2018, in Las Vegas, Nevada.

The transition to robotic MIS was undertaken in Denmark from 2008 to 2013, with the centralization of endometrial cancer treatment in 2012. Over the span of 10 years, the surgical approach to treatment changed from 97% open access surgery to 95% MIS.

For the prospective cohort study, more than 7,000 women with endometrial cancer who received a hysterectomy from January 2005 to June 2015 were grouped by those receiving surgical care before (group 1) and after (group 2) robotic MIS implementation in Denmark. A total of 5,654 women with FIGO Stage I–II endometrial cancer were included in the final study.

Severe complications were 7.3% in group 1 and 6.2% in group 2 (odds ratio, 1.38; 95% confidence interval [CI], 1.10–1.73). Five-year survival rates were significantly lower before robotic MIS was implemented (hazard ratio, 1.22; 95% CI, 1.05–1.41), and no difference was found between laparoscopic and robotic MIS.

The authors concluded that nationwide implementation of robotic MIS enabled a shift toward all types of MIS (with a 73% reduction in hysterectomies performed by laparotomy) and translated into reduced risk of severe complications and increased survival.

How do these results compare with those in the United States?

According to Erica Dun, MD, MPH, who provided commentary for Dr. Joergensen’s study, the United States adopted robotic MIS in the early 2000s. Around 2008, 14% of hysterectomies performed for early-stage endometrial cancer were done through a MIS approach.² In 2014, after a study in which Walker and colleagues found that laparoscopy was safe and feasible compared with laparotomy,³ the American College of Obstetricians and Gynecologists, jointly with the Society of Gynecologic Oncologists, stated that “MIS should be embraced as the standard surgical approach for comprehensive surgical staging in women with endometrial cancer.”⁴

Dr. Dun pointed out that Casarin and colleagues found in 2018 that 71.4% of surgeries performed in the United States for endometrial cancer were performed through MIS.⁵ That number rose to 86.5% MIS (72.5% robot-assisted) for centers of the National Comprehensive Cancer Network.⁶

Dr. Dun concluded that nationwide implementation of robotic MIS is feasible for gynecologic oncologists, and it is beneficial for patients.

Investigators at the University of Michigan, Ann Arbor, found that a simple patient decision aid can be a useful tool in providing adequate postsurgical pain control to patients while reducing the number of opioid tablets in the community. The shared decision-making aid focuses on educating the patient about opioid use and engages her in an appropriate postoperative pain management plan. Results from this prospective quality improvement study were presented in a poster at the 47th AAGL Global Congress on Minimally Invasive Gynecology (Las Vegas, Nevada, November 11–15, 2018).¹

Annmarie Vilkins, DO, and colleagues’ aim was to evaluate the impact of shared decision-making through the use of a patient decision aid targeting posthysterectomy pain management and opioid use. Can such a targeted strategy help decrease posthysterectomy opioid distribution in the community without compromising patient pain control or satisfaction?

The authors noted that more than 46 people die each day from an overdose involving prescription opioids.² Studies have shown that patients actually use significantly fewer opioid tablets than the amount clinicians generally prescribe following ObGyn surgeries.^3,4 Unused prescription opioid availability has the potential for accidental use or intentional misuse of the unneeded drugs by others.

Study methods

The investigators included all English-speaking patients undergoing hysterectomy for benign disease at their institution from March 1 through July 31, 2018. Data were analyzed from women undergoing laparoscopic, vaginal, or abdominal hysterectomy before (n = 195) and after (n = 177) the decision aid was implemented.

Preoperative education. In the preoperative area, patients were uniformly educated regarding postoperative pain expectations (for example, it is normal to have some pain; the goal is to manage your pain so you can function; some women do not require opioid medications after surgery), risks of opioid medications (such as dependence or addiction; misuse of leftover pills by others), adverse effects (drowsiness; confusion), and the recommended postoperative pain management schedule.

Postoperatively, pain medications included ibuprofen around the clock, acetaminophen as needed (used with caution when hydrocodone with acetaminophen was also prescribed), and opioids only if needed.

Discharge medication planning. Using a visual scale, the investigators then educated patients regarding the maximum number of opioid tablets permitted to be prescribed according to department guidelines and the average number of opioid tablets that a typical patient uses. The number of opioid tablets prescribed varied based on route of hysterectomy (laparoscopic, abdominal, or vaginal). For example, for a laparoscopic hysterectomy, the maximum allowed prescription for oxycodone was 20 tablets, while patients used an average number of 10 tablets.

The patient was then asked to choose her desired number of tablets with which she would like to be discharged.

Structured telephone calls were made to patients 2 weeks postoperatively.

Impact of the decision aid on opioid prescribing

Before implementation of the decision aid, the average number of opioid pills prescribed at discharge was 25 (median, 20–35), while that number dropped to 10 (median, 10–15) after the aid’s implementation. Similarly, the average oral morphine equivalents (OMEs) at time of discharge was 150 (interquartile range [IQR], 120–200) before decision aid implementation and 75 (IQR, 25–150) after decision aid implementation. Similar reductions in average OMEs were observed before and after the aid’s implementation across the 3 hysterectomy routes.

Continue to: According to the type of opioid...

According to the type of opioid prescribed at discharge, hydrocodone 5 mg was prescribed in 99 cases (50.8%) before decision aid implementation and in 14 cases (7.9%) after implementation. By contrast, oxycodone 5 mg was prescribed in 85 cases (43.6%) before implementation and in 149 cases (84.2%) after implementation.

The number of refill requests was similar before (n = 11 [5.6%]) and after (n = 12 [6.8%]) the aid’s implementation.

Tool reduced opioid availability in the community

The use of a simple patient decision aid—which focuses on opioid education and engages patients in an appropriate postoperative pain management plan—can result in fewer opioid tablets in the community while still providing adequate pain control, the authors concluded.

Online resource. For more on targeted strategies to optimize opioid prescribing after surgery, visit the University of Michigan’s Opioid Prescribing Engagement Network (OPEN) at http://michigan-open.org.

Investigators at the University of Michigan, Ann Arbor, found that a simple patient decision aid can be a useful tool in providing adequate postsurgical pain control to patients while reducing the number of opioid tablets in the community. The shared decision-making aid focuses on educating the patient about opioid use and engages her in an appropriate postoperative pain management plan. Results from this prospective quality improvement study were presented in a poster at the 47th AAGL Global Congress on Minimally Invasive Gynecology (Las Vegas, Nevada, November 11–15, 2018).¹

Annmarie Vilkins, DO, and colleagues’ aim was to evaluate the impact of shared decision-making through the use of a patient decision aid targeting posthysterectomy pain management and opioid use. Can such a targeted strategy help decrease posthysterectomy opioid distribution in the community without compromising patient pain control or satisfaction?

The authors noted that more than 46 people die each day from an overdose involving prescription opioids.² Studies have shown that patients actually use significantly fewer opioid tablets than the amount clinicians generally prescribe following ObGyn surgeries.^3,4 Unused prescription opioid availability has the potential for accidental use or intentional misuse of the unneeded drugs by others.

Study methods

The investigators included all English-speaking patients undergoing hysterectomy for benign disease at their institution from March 1 through July 31, 2018. Data were analyzed from women undergoing laparoscopic, vaginal, or abdominal hysterectomy before (n = 195) and after (n = 177) the decision aid was implemented.

Preoperative education. In the preoperative area, patients were uniformly educated regarding postoperative pain expectations (for example, it is normal to have some pain; the goal is to manage your pain so you can function; some women do not require opioid medications after surgery), risks of opioid medications (such as dependence or addiction; misuse of leftover pills by others), adverse effects (drowsiness; confusion), and the recommended postoperative pain management schedule.

Postoperatively, pain medications included ibuprofen around the clock, acetaminophen as needed (used with caution when hydrocodone with acetaminophen was also prescribed), and opioids only if needed.

Discharge medication planning. Using a visual scale, the investigators then educated patients regarding the maximum number of opioid tablets permitted to be prescribed according to department guidelines and the average number of opioid tablets that a typical patient uses. The number of opioid tablets prescribed varied based on route of hysterectomy (laparoscopic, abdominal, or vaginal). For example, for a laparoscopic hysterectomy, the maximum allowed prescription for oxycodone was 20 tablets, while patients used an average number of 10 tablets.

The patient was then asked to choose her desired number of tablets with which she would like to be discharged.

Structured telephone calls were made to patients 2 weeks postoperatively.

Impact of the decision aid on opioid prescribing

Before implementation of the decision aid, the average number of opioid pills prescribed at discharge was 25 (median, 20–35), while that number dropped to 10 (median, 10–15) after the aid’s implementation. Similarly, the average oral morphine equivalents (OMEs) at time of discharge was 150 (interquartile range [IQR], 120–200) before decision aid implementation and 75 (IQR, 25–150) after decision aid implementation. Similar reductions in average OMEs were observed before and after the aid’s implementation across the 3 hysterectomy routes.

Continue to: According to the type of opioid...

According to the type of opioid prescribed at discharge, hydrocodone 5 mg was prescribed in 99 cases (50.8%) before decision aid implementation and in 14 cases (7.9%) after implementation. By contrast, oxycodone 5 mg was prescribed in 85 cases (43.6%) before implementation and in 149 cases (84.2%) after implementation.

The number of refill requests was similar before (n = 11 [5.6%]) and after (n = 12 [6.8%]) the aid’s implementation.

Tool reduced opioid availability in the community

The use of a simple patient decision aid—which focuses on opioid education and engages patients in an appropriate postoperative pain management plan—can result in fewer opioid tablets in the community while still providing adequate pain control, the authors concluded.

Online resource. For more on targeted strategies to optimize opioid prescribing after surgery, visit the University of Michigan’s Opioid Prescribing Engagement Network (OPEN) at http://michigan-open.org.

Investigators at the University of Michigan, Ann Arbor, found that a simple patient decision aid can be a useful tool in providing adequate postsurgical pain control to patients while reducing the number of opioid tablets in the community. The shared decision-making aid focuses on educating the patient about opioid use and engages her in an appropriate postoperative pain management plan. Results from this prospective quality improvement study were presented in a poster at the 47th AAGL Global Congress on Minimally Invasive Gynecology (Las Vegas, Nevada, November 11–15, 2018).¹

Annmarie Vilkins, DO, and colleagues’ aim was to evaluate the impact of shared decision-making through the use of a patient decision aid targeting posthysterectomy pain management and opioid use. Can such a targeted strategy help decrease posthysterectomy opioid distribution in the community without compromising patient pain control or satisfaction?

The authors noted that more than 46 people die each day from an overdose involving prescription opioids.² Studies have shown that patients actually use significantly fewer opioid tablets than the amount clinicians generally prescribe following ObGyn surgeries.^3,4 Unused prescription opioid availability has the potential for accidental use or intentional misuse of the unneeded drugs by others.

Study methods

The investigators included all English-speaking patients undergoing hysterectomy for benign disease at their institution from March 1 through July 31, 2018. Data were analyzed from women undergoing laparoscopic, vaginal, or abdominal hysterectomy before (n = 195) and after (n = 177) the decision aid was implemented.

Preoperative education. In the preoperative area, patients were uniformly educated regarding postoperative pain expectations (for example, it is normal to have some pain; the goal is to manage your pain so you can function; some women do not require opioid medications after surgery), risks of opioid medications (such as dependence or addiction; misuse of leftover pills by others), adverse effects (drowsiness; confusion), and the recommended postoperative pain management schedule.

Postoperatively, pain medications included ibuprofen around the clock, acetaminophen as needed (used with caution when hydrocodone with acetaminophen was also prescribed), and opioids only if needed.

Discharge medication planning. Using a visual scale, the investigators then educated patients regarding the maximum number of opioid tablets permitted to be prescribed according to department guidelines and the average number of opioid tablets that a typical patient uses. The number of opioid tablets prescribed varied based on route of hysterectomy (laparoscopic, abdominal, or vaginal). For example, for a laparoscopic hysterectomy, the maximum allowed prescription for oxycodone was 20 tablets, while patients used an average number of 10 tablets.

The patient was then asked to choose her desired number of tablets with which she would like to be discharged.

Structured telephone calls were made to patients 2 weeks postoperatively.

Impact of the decision aid on opioid prescribing

Before implementation of the decision aid, the average number of opioid pills prescribed at discharge was 25 (median, 20–35), while that number dropped to 10 (median, 10–15) after the aid’s implementation. Similarly, the average oral morphine equivalents (OMEs) at time of discharge was 150 (interquartile range [IQR], 120–200) before decision aid implementation and 75 (IQR, 25–150) after decision aid implementation. Similar reductions in average OMEs were observed before and after the aid’s implementation across the 3 hysterectomy routes.

Continue to: According to the type of opioid...

According to the type of opioid prescribed at discharge, hydrocodone 5 mg was prescribed in 99 cases (50.8%) before decision aid implementation and in 14 cases (7.9%) after implementation. By contrast, oxycodone 5 mg was prescribed in 85 cases (43.6%) before implementation and in 149 cases (84.2%) after implementation.

The number of refill requests was similar before (n = 11 [5.6%]) and after (n = 12 [6.8%]) the aid’s implementation.

Tool reduced opioid availability in the community

The use of a simple patient decision aid—which focuses on opioid education and engages patients in an appropriate postoperative pain management plan—can result in fewer opioid tablets in the community while still providing adequate pain control, the authors concluded.

Online resource. For more on targeted strategies to optimize opioid prescribing after surgery, visit the University of Michigan’s Opioid Prescribing Engagement Network (OPEN) at http://michigan-open.org.

The past year was an exciting one in obstetrics. The landmark ARRIVE trial presented at the Society for Maternal-Fetal Medicine’s (SMFM) annual meeting and subsequently published in the New England Journal of Medicine contradicted a long-held belief about the safety of elective labor induction. In a large randomized trial, Cahill and colleagues took a controversial but practical clinical question about second-stage labor management and answered it for the practicing obstetrician in the trenches. Finally, the American College of Obstetricians and Gynecologists (ACOG) placed new emphasis on the oft overlooked but increasingly more complicated postpartum period, offering guidance to support improving care for women in this transitional period.

Ultimately, this was the year of the patient, as research, clinical guidelines, and education focused on how to achieve the best in safety and quality of care for delivery planning, the delivery itself, and the so-called fourth trimester.

ARRIVE: Labor induction at 39 weeks reduces CD rate with no difference in perinatal death or serious outcomes 

Grobman WA, Rice MM, Reddy UM, et al; for the Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. Labor induction versus expectant management in low-risk nulliparous women. N Engl J Med. 2018;379:513-523.

The term "elective induction of labor" has long had a negative connotation because of its association with increased CD rates and adverse perinatal outcomes. This view was based on results from older observational studies that compared outcomes for labor induction with those of spontaneous labor. In more recent observational studies that more appropriately compared labor induction with expectant management, however, elective induction of labor appears to be associated with similar CD rates and perinatal outcomes. 
To test the hypothesis that elective induction would have a lower risk for perinatal death or severe neonatal complications than expectant management in low-risk nulliparous women, Grobman and colleagues conducted A Randomized Trial of Induction Versus Expectant Management (ARRIVE).1 

Study population, timing of delivery, and trial outcomes 

This randomized controlled trial included 6,106 women at 41 US centers in the Maternal-Fetal Medicine Units Network of the Eunice Kennedy Shriver National Institute of Child Health and Human Development. Study participants were low-risk nulliparous women with a singleton vertex fetus who were randomly assigned to induction of labor at 39 to 39 4/7 weeks (n = 3,062) or expectant management (n = 3,044) until 40 5/7 to 42 2/7 weeks. 

"Low risk" was defined as having no maternal or fetal indication for delivery prior to 40 5/7 weeks. Reliable gestational dating was required.  

While no specific protocol for induction of labor management was required, there were 2 requests: 1) Cervical ripening was requested for an unfavorable cervix (63% of participants had a modified Bishop score <5), and 2) a duration of at least 12 hours after cervical ripening, rupture of membranes, and use of uterine stimulant was requested before performing a CD for "failed induction" (if medically appropriate). 

The primary outcome was a composite of perinatal death or serious neonatal complications. The main secondary outcome was CD. 

Potentially game-changing findings 

The investigators found that there was no statistically significant difference between the elective induction and expectant management groups for the primary composite perinatal outcome (4.3% vs 5.4%; P = .049, with P<.046 prespecified for significance). In addition, the rate of CD was significantly lower in the labor induction group than in the expectant management group (18.6% vs 22.2%; P<.001). 
Other significant findings in secondary outcomes included the following: 

• Hypertensive disorders of pregnancy were significantly lower in the labor induction group compared with the expectant management group (9.1% vs 14.1%; P<.001). 
• The labor induction group had a longer length of stay in the labor and delivery unit but a shorter postpartum hospital stay. 
• The labor induction group reported less pain and more control during labor. 

Results refute negative notion of elective labor induction 

The authors concluded that in a low-risk nulliparous patient population, elective induction of labor at 39 weeks does not increase the risk for adverse perinatal outcomes and decreases the rate of CD and hypertensive disorders of pregnancy. Additionally, they noted that induction at 39 weeks should not be avoided with the goal of preventing CD, as even women with an unfavorable cervix had a lower rate of CD in the induction group compared with the expectant management group.

Continue to: Immediate pushing in second stage...

Immediate pushing in second stage offers benefits and is preferable to delayed pushing 

Cahill AG, Srinivas SK, Tita AT, et al. Effect of immediate vs delayed pushing on rates of spontaneous vaginal delivery among nulliparous women receiving neuraxial analgesia: a randomized clinical trial. JAMA. 2018;320:1444-1454. 

In a randomized trial of 2,414 women, Cahill and colleagues sought to answer a seemingly simple question: What is the best timing for pushing during the second stage of labor--immediate or delayed? 

Practical management of the second stage of labor (defined as complete cervical dilation to the delivery of the infant) varies by provider and setting, and previous data on pushing efforts are conflicting. Delayed pushing, or "laboring down," has been suggested to allow passive fetal rotation and to conserve maternal energy for pushing. Older studies have shown that delayed pushing decreases the rate of operative delivery. More recent study data have not demonstrated a difference between immediate and delayed pushing techniques on vaginal delivery rates and have noted that increased maternal and neonatal morbidities are associated with a longer second stage of labor. 

The recent trial by Cahill and colleagues was designed to determine the effect of these 2 techniques on spontaneous vaginal delivery rates and on maternal and neonatal morbidities.⁴ 

Large study population 

This randomized pragmatic trial was conducted at 6 centers in the United States. Study participants (2,404 women completed the study) were nulliparous women at 37 or more weeks' gestation with neuraxial anesthesia who were randomly assigned at complete cervical dilation either to immediate pushing (n = 1,200) or to delayed pushing, that is, instructed to wait 60 minutes before starting to push (n = 1,204). The obstetric provider determined the rest of the labor management. 

The primary outcome was the rate of spontaneous vaginal delivery. Secondary outcomes included duration of the second stage of labor, duration of active pushing, operative vaginal delivery, CD, and several maternal assessments (postpartum hemorrhage, chorioamnionitis, endometritis, and perineal lacerations). 

Both groups had similar vaginal delivery rates, differences in some measures 

There was no difference in the primary outcome between the 2 groups: The spontaneous vaginal delivery rate was 85.9% (n = 1,031) in the immediate pushing group and 86.5% (n = 1,041) in the delayed pushing group (P = .67).  
Analysis of secondary outcomes revealed several significant differences: 

• decreased total time for the second stage of labor in the immediate pushing group compared with the delayed pushing group (102.4 vs 134.2 minutes) but longer active pushing time (83.7 vs 74.5 minutes) 
• a lower rate of postpartum hemorrhage, chorioamnionitis in the second stage, neonatal acidemia, and suspected neonatal sepsis in the immediate pushing group 
• a higher rate of third-degree perineal lacerations in the immediate pushing group. 

 No difference was found between groups in rates of operative vaginal deliveries, CDs, endometritis, overall perineal lacerations, or spontaneous vaginal delivery by fetal station or occiput position. 

Authors' takeaway 

The authors concluded that since delayed pushing does not increase spontaneous vaginal delivery rates and increases the duration of the second stage of labor and both maternal and neonatal morbidity, immediate pushing may be preferred in this patient population. 

ACOG aims to optimize postpartum care 

American College of Obstetricians and Gynecologists. ACOG Committee Opinion No. 736. Optimizing postpartum care. Obstet Gynecol. 2018;131:e140-e150. 

In May 2018, ACOG released "Optimizing postpartum care," a committee opinion that proposes a new model of comprehensive postpartum care focused on improving both short- and long-term health outcomes for women and infants. (This replaces the June 2016 committee opinion No. 666.) Described as "the fourth trimester," the postpartum period is a critical transitional period in which both pregnancy-related and pre-existing conditions may affect maternal, neonatal, and family status; half of pregnancy-related maternal deaths occur during the postpartum period.⁶ 

The postpartum visit: Often a lost opportunity 

ACOG cites that up to 40% of women in the United States do not attend their postpartum visit.6 Many aspects of the postpartum visit, including follow-up for chronic diseases, mental health screening, and contraceptive counseling, provide opportunities for acute intervention as well as establishment of healthy behaviors. Some studies have shown that postpartum depression, breastfeeding, and patient satisfaction outcomes improve as a result of postpartum engagement. 

Continue to: ACOG's recommendations...

ACOG's recommendations 

Ongoing process. ACOG's first proposed change concerns the structure of the postpartum visit itself, which traditionally has been a single visit with a provider at approximately 6 weeks postpartum. Postpartum care plans actually should be started before birth, during regular prenatal care, and adjusted in the hospital as needed so that the provider can educate patients about the issues they may face and resources they may need during this time. This prenatal preparation hopefully will encourage more patients to attend their postpartum visits. 

Increased provider contact. Another proposed change is that after delivery, the patient should have contact with a provider within the first 3 weeks postpartum. For high-risk patients, this may involve an in-person clinic visit as soon as 3 to 10 days postpartum (for hypertensive disorders of pregnancy) or at 1 to 2 weeks (for postpartum depression screening, incision checks, and lactation issues). For lower-risk patients, a phone call may be appropriate and/or preferred. Ongoing follow-up for all patients before the final postpartum visit should be individualized. 

Postpartum visit and care transition. ACOG recommends a comprehensive postpartum visit at 4 to 12 weeks to fully evaluate the woman's physical, social, and psychologic well-being and to serve as a transition from pregnancy care to well-woman care. This is a large order and includes evaluation of the following: 

• mood and emotional well-being 
• infant care and feeding 
• sexuality, contraception, and birth spacing 
• sleep and fatigue 
• physical recovery from birth 
• chronic disease management and transition to primary care provider 
• health maintenance 
• review of labor and delivery course if needed 
• review of risks and recommendations for future pregnancies. 

After these components are addressed, it is expected that the patient will be transitioned to a primary care provider (who may continue to be the ObGyn, as appropriate) to coordinate her future care in the primary medical home.  

Useful resource for adopting new paradigm 

ACOG's recommendations are somewhat daunting, and these changes will require education and resources, a significant increase in obstetric provider time and effort, and consideration of policy change regarding such issues as parental leave and postpartum care reimbursement. As a start, ACOG has developed an online aid for health care providers called "Postpartum toolkit" (https://www.acog.org/About-ACOG/ACOG-Departments/Toolkits-for-Health-Care-Providers/Postpartum-Toolkit), which provides education and resources for all steps in the process and can be individualized for each practice and patient.⁷  
 

The past year was an exciting one in obstetrics. The landmark ARRIVE trial presented at the Society for Maternal-Fetal Medicine’s (SMFM) annual meeting and subsequently published in the New England Journal of Medicine contradicted a long-held belief about the safety of elective labor induction. In a large randomized trial, Cahill and colleagues took a controversial but practical clinical question about second-stage labor management and answered it for the practicing obstetrician in the trenches. Finally, the American College of Obstetricians and Gynecologists (ACOG) placed new emphasis on the oft overlooked but increasingly more complicated postpartum period, offering guidance to support improving care for women in this transitional period.

Ultimately, this was the year of the patient, as research, clinical guidelines, and education focused on how to achieve the best in safety and quality of care for delivery planning, the delivery itself, and the so-called fourth trimester.

ARRIVE: Labor induction at 39 weeks reduces CD rate with no difference in perinatal death or serious outcomes 

Grobman WA, Rice MM, Reddy UM, et al; for the Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. Labor induction versus expectant management in low-risk nulliparous women. N Engl J Med. 2018;379:513-523.

The term "elective induction of labor" has long had a negative connotation because of its association with increased CD rates and adverse perinatal outcomes. This view was based on results from older observational studies that compared outcomes for labor induction with those of spontaneous labor. In more recent observational studies that more appropriately compared labor induction with expectant management, however, elective induction of labor appears to be associated with similar CD rates and perinatal outcomes. 
To test the hypothesis that elective induction would have a lower risk for perinatal death or severe neonatal complications than expectant management in low-risk nulliparous women, Grobman and colleagues conducted A Randomized Trial of Induction Versus Expectant Management (ARRIVE).1 

Study population, timing of delivery, and trial outcomes 

This randomized controlled trial included 6,106 women at 41 US centers in the Maternal-Fetal Medicine Units Network of the Eunice Kennedy Shriver National Institute of Child Health and Human Development. Study participants were low-risk nulliparous women with a singleton vertex fetus who were randomly assigned to induction of labor at 39 to 39 4/7 weeks (n = 3,062) or expectant management (n = 3,044) until 40 5/7 to 42 2/7 weeks. 

"Low risk" was defined as having no maternal or fetal indication for delivery prior to 40 5/7 weeks. Reliable gestational dating was required.  

While no specific protocol for induction of labor management was required, there were 2 requests: 1) Cervical ripening was requested for an unfavorable cervix (63% of participants had a modified Bishop score <5), and 2) a duration of at least 12 hours after cervical ripening, rupture of membranes, and use of uterine stimulant was requested before performing a CD for "failed induction" (if medically appropriate). 

The primary outcome was a composite of perinatal death or serious neonatal complications. The main secondary outcome was CD. 

Potentially game-changing findings 

The investigators found that there was no statistically significant difference between the elective induction and expectant management groups for the primary composite perinatal outcome (4.3% vs 5.4%; P = .049, with P<.046 prespecified for significance). In addition, the rate of CD was significantly lower in the labor induction group than in the expectant management group (18.6% vs 22.2%; P<.001). 
Other significant findings in secondary outcomes included the following: 

• Hypertensive disorders of pregnancy were significantly lower in the labor induction group compared with the expectant management group (9.1% vs 14.1%; P<.001). 
• The labor induction group had a longer length of stay in the labor and delivery unit but a shorter postpartum hospital stay. 
• The labor induction group reported less pain and more control during labor. 

Results refute negative notion of elective labor induction 

The authors concluded that in a low-risk nulliparous patient population, elective induction of labor at 39 weeks does not increase the risk for adverse perinatal outcomes and decreases the rate of CD and hypertensive disorders of pregnancy. Additionally, they noted that induction at 39 weeks should not be avoided with the goal of preventing CD, as even women with an unfavorable cervix had a lower rate of CD in the induction group compared with the expectant management group.

Continue to: Immediate pushing in second stage...

Immediate pushing in second stage offers benefits and is preferable to delayed pushing 

Cahill AG, Srinivas SK, Tita AT, et al. Effect of immediate vs delayed pushing on rates of spontaneous vaginal delivery among nulliparous women receiving neuraxial analgesia: a randomized clinical trial. JAMA. 2018;320:1444-1454. 

In a randomized trial of 2,414 women, Cahill and colleagues sought to answer a seemingly simple question: What is the best timing for pushing during the second stage of labor--immediate or delayed? 

Practical management of the second stage of labor (defined as complete cervical dilation to the delivery of the infant) varies by provider and setting, and previous data on pushing efforts are conflicting. Delayed pushing, or "laboring down," has been suggested to allow passive fetal rotation and to conserve maternal energy for pushing. Older studies have shown that delayed pushing decreases the rate of operative delivery. More recent study data have not demonstrated a difference between immediate and delayed pushing techniques on vaginal delivery rates and have noted that increased maternal and neonatal morbidities are associated with a longer second stage of labor. 

The recent trial by Cahill and colleagues was designed to determine the effect of these 2 techniques on spontaneous vaginal delivery rates and on maternal and neonatal morbidities.⁴ 

Large study population 

This randomized pragmatic trial was conducted at 6 centers in the United States. Study participants (2,404 women completed the study) were nulliparous women at 37 or more weeks' gestation with neuraxial anesthesia who were randomly assigned at complete cervical dilation either to immediate pushing (n = 1,200) or to delayed pushing, that is, instructed to wait 60 minutes before starting to push (n = 1,204). The obstetric provider determined the rest of the labor management. 

The primary outcome was the rate of spontaneous vaginal delivery. Secondary outcomes included duration of the second stage of labor, duration of active pushing, operative vaginal delivery, CD, and several maternal assessments (postpartum hemorrhage, chorioamnionitis, endometritis, and perineal lacerations). 

Both groups had similar vaginal delivery rates, differences in some measures 

There was no difference in the primary outcome between the 2 groups: The spontaneous vaginal delivery rate was 85.9% (n = 1,031) in the immediate pushing group and 86.5% (n = 1,041) in the delayed pushing group (P = .67).  
Analysis of secondary outcomes revealed several significant differences: 

• decreased total time for the second stage of labor in the immediate pushing group compared with the delayed pushing group (102.4 vs 134.2 minutes) but longer active pushing time (83.7 vs 74.5 minutes) 
• a lower rate of postpartum hemorrhage, chorioamnionitis in the second stage, neonatal acidemia, and suspected neonatal sepsis in the immediate pushing group 
• a higher rate of third-degree perineal lacerations in the immediate pushing group. 

 No difference was found between groups in rates of operative vaginal deliveries, CDs, endometritis, overall perineal lacerations, or spontaneous vaginal delivery by fetal station or occiput position. 

Authors' takeaway 

The authors concluded that since delayed pushing does not increase spontaneous vaginal delivery rates and increases the duration of the second stage of labor and both maternal and neonatal morbidity, immediate pushing may be preferred in this patient population. 

ACOG aims to optimize postpartum care 

American College of Obstetricians and Gynecologists. ACOG Committee Opinion No. 736. Optimizing postpartum care. Obstet Gynecol. 2018;131:e140-e150. 

In May 2018, ACOG released "Optimizing postpartum care," a committee opinion that proposes a new model of comprehensive postpartum care focused on improving both short- and long-term health outcomes for women and infants. (This replaces the June 2016 committee opinion No. 666.) Described as "the fourth trimester," the postpartum period is a critical transitional period in which both pregnancy-related and pre-existing conditions may affect maternal, neonatal, and family status; half of pregnancy-related maternal deaths occur during the postpartum period.⁶ 

The postpartum visit: Often a lost opportunity 

ACOG cites that up to 40% of women in the United States do not attend their postpartum visit.6 Many aspects of the postpartum visit, including follow-up for chronic diseases, mental health screening, and contraceptive counseling, provide opportunities for acute intervention as well as establishment of healthy behaviors. Some studies have shown that postpartum depression, breastfeeding, and patient satisfaction outcomes improve as a result of postpartum engagement. 

Continue to: ACOG's recommendations...

ACOG's recommendations 

Ongoing process. ACOG's first proposed change concerns the structure of the postpartum visit itself, which traditionally has been a single visit with a provider at approximately 6 weeks postpartum. Postpartum care plans actually should be started before birth, during regular prenatal care, and adjusted in the hospital as needed so that the provider can educate patients about the issues they may face and resources they may need during this time. This prenatal preparation hopefully will encourage more patients to attend their postpartum visits. 

Increased provider contact. Another proposed change is that after delivery, the patient should have contact with a provider within the first 3 weeks postpartum. For high-risk patients, this may involve an in-person clinic visit as soon as 3 to 10 days postpartum (for hypertensive disorders of pregnancy) or at 1 to 2 weeks (for postpartum depression screening, incision checks, and lactation issues). For lower-risk patients, a phone call may be appropriate and/or preferred. Ongoing follow-up for all patients before the final postpartum visit should be individualized. 

Postpartum visit and care transition. ACOG recommends a comprehensive postpartum visit at 4 to 12 weeks to fully evaluate the woman's physical, social, and psychologic well-being and to serve as a transition from pregnancy care to well-woman care. This is a large order and includes evaluation of the following: 

• mood and emotional well-being 
• infant care and feeding 
• sexuality, contraception, and birth spacing 
• sleep and fatigue 
• physical recovery from birth 
• chronic disease management and transition to primary care provider 
• health maintenance 
• review of labor and delivery course if needed 
• review of risks and recommendations for future pregnancies. 

After these components are addressed, it is expected that the patient will be transitioned to a primary care provider (who may continue to be the ObGyn, as appropriate) to coordinate her future care in the primary medical home.  

Useful resource for adopting new paradigm 

ACOG's recommendations are somewhat daunting, and these changes will require education and resources, a significant increase in obstetric provider time and effort, and consideration of policy change regarding such issues as parental leave and postpartum care reimbursement. As a start, ACOG has developed an online aid for health care providers called "Postpartum toolkit" (https://www.acog.org/About-ACOG/ACOG-Departments/Toolkits-for-Health-Care-Providers/Postpartum-Toolkit), which provides education and resources for all steps in the process and can be individualized for each practice and patient.⁷  
 

The past year was an exciting one in obstetrics. The landmark ARRIVE trial presented at the Society for Maternal-Fetal Medicine’s (SMFM) annual meeting and subsequently published in the New England Journal of Medicine contradicted a long-held belief about the safety of elective labor induction. In a large randomized trial, Cahill and colleagues took a controversial but practical clinical question about second-stage labor management and answered it for the practicing obstetrician in the trenches. Finally, the American College of Obstetricians and Gynecologists (ACOG) placed new emphasis on the oft overlooked but increasingly more complicated postpartum period, offering guidance to support improving care for women in this transitional period.

Ultimately, this was the year of the patient, as research, clinical guidelines, and education focused on how to achieve the best in safety and quality of care for delivery planning, the delivery itself, and the so-called fourth trimester.

ARRIVE: Labor induction at 39 weeks reduces CD rate with no difference in perinatal death or serious outcomes 

Grobman WA, Rice MM, Reddy UM, et al; for the Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. Labor induction versus expectant management in low-risk nulliparous women. N Engl J Med. 2018;379:513-523.

The term "elective induction of labor" has long had a negative connotation because of its association with increased CD rates and adverse perinatal outcomes. This view was based on results from older observational studies that compared outcomes for labor induction with those of spontaneous labor. In more recent observational studies that more appropriately compared labor induction with expectant management, however, elective induction of labor appears to be associated with similar CD rates and perinatal outcomes. 
To test the hypothesis that elective induction would have a lower risk for perinatal death or severe neonatal complications than expectant management in low-risk nulliparous women, Grobman and colleagues conducted A Randomized Trial of Induction Versus Expectant Management (ARRIVE).1 

Study population, timing of delivery, and trial outcomes 

This randomized controlled trial included 6,106 women at 41 US centers in the Maternal-Fetal Medicine Units Network of the Eunice Kennedy Shriver National Institute of Child Health and Human Development. Study participants were low-risk nulliparous women with a singleton vertex fetus who were randomly assigned to induction of labor at 39 to 39 4/7 weeks (n = 3,062) or expectant management (n = 3,044) until 40 5/7 to 42 2/7 weeks. 

"Low risk" was defined as having no maternal or fetal indication for delivery prior to 40 5/7 weeks. Reliable gestational dating was required.  

While no specific protocol for induction of labor management was required, there were 2 requests: 1) Cervical ripening was requested for an unfavorable cervix (63% of participants had a modified Bishop score <5), and 2) a duration of at least 12 hours after cervical ripening, rupture of membranes, and use of uterine stimulant was requested before performing a CD for "failed induction" (if medically appropriate). 

The primary outcome was a composite of perinatal death or serious neonatal complications. The main secondary outcome was CD. 

Potentially game-changing findings 

The investigators found that there was no statistically significant difference between the elective induction and expectant management groups for the primary composite perinatal outcome (4.3% vs 5.4%; P = .049, with P<.046 prespecified for significance). In addition, the rate of CD was significantly lower in the labor induction group than in the expectant management group (18.6% vs 22.2%; P<.001). 
Other significant findings in secondary outcomes included the following: 

• Hypertensive disorders of pregnancy were significantly lower in the labor induction group compared with the expectant management group (9.1% vs 14.1%; P<.001). 
• The labor induction group had a longer length of stay in the labor and delivery unit but a shorter postpartum hospital stay. 
• The labor induction group reported less pain and more control during labor. 

Results refute negative notion of elective labor induction 

The authors concluded that in a low-risk nulliparous patient population, elective induction of labor at 39 weeks does not increase the risk for adverse perinatal outcomes and decreases the rate of CD and hypertensive disorders of pregnancy. Additionally, they noted that induction at 39 weeks should not be avoided with the goal of preventing CD, as even women with an unfavorable cervix had a lower rate of CD in the induction group compared with the expectant management group.

Continue to: Immediate pushing in second stage...

Immediate pushing in second stage offers benefits and is preferable to delayed pushing 

Cahill AG, Srinivas SK, Tita AT, et al. Effect of immediate vs delayed pushing on rates of spontaneous vaginal delivery among nulliparous women receiving neuraxial analgesia: a randomized clinical trial. JAMA. 2018;320:1444-1454. 

In a randomized trial of 2,414 women, Cahill and colleagues sought to answer a seemingly simple question: What is the best timing for pushing during the second stage of labor--immediate or delayed? 

Practical management of the second stage of labor (defined as complete cervical dilation to the delivery of the infant) varies by provider and setting, and previous data on pushing efforts are conflicting. Delayed pushing, or "laboring down," has been suggested to allow passive fetal rotation and to conserve maternal energy for pushing. Older studies have shown that delayed pushing decreases the rate of operative delivery. More recent study data have not demonstrated a difference between immediate and delayed pushing techniques on vaginal delivery rates and have noted that increased maternal and neonatal morbidities are associated with a longer second stage of labor. 

The recent trial by Cahill and colleagues was designed to determine the effect of these 2 techniques on spontaneous vaginal delivery rates and on maternal and neonatal morbidities.⁴ 

Large study population 

This randomized pragmatic trial was conducted at 6 centers in the United States. Study participants (2,404 women completed the study) were nulliparous women at 37 or more weeks' gestation with neuraxial anesthesia who were randomly assigned at complete cervical dilation either to immediate pushing (n = 1,200) or to delayed pushing, that is, instructed to wait 60 minutes before starting to push (n = 1,204). The obstetric provider determined the rest of the labor management. 

The primary outcome was the rate of spontaneous vaginal delivery. Secondary outcomes included duration of the second stage of labor, duration of active pushing, operative vaginal delivery, CD, and several maternal assessments (postpartum hemorrhage, chorioamnionitis, endometritis, and perineal lacerations). 

Both groups had similar vaginal delivery rates, differences in some measures 

There was no difference in the primary outcome between the 2 groups: The spontaneous vaginal delivery rate was 85.9% (n = 1,031) in the immediate pushing group and 86.5% (n = 1,041) in the delayed pushing group (P = .67).  
Analysis of secondary outcomes revealed several significant differences: 

• decreased total time for the second stage of labor in the immediate pushing group compared with the delayed pushing group (102.4 vs 134.2 minutes) but longer active pushing time (83.7 vs 74.5 minutes) 
• a lower rate of postpartum hemorrhage, chorioamnionitis in the second stage, neonatal acidemia, and suspected neonatal sepsis in the immediate pushing group 
• a higher rate of third-degree perineal lacerations in the immediate pushing group. 

 No difference was found between groups in rates of operative vaginal deliveries, CDs, endometritis, overall perineal lacerations, or spontaneous vaginal delivery by fetal station or occiput position. 

Authors' takeaway 

The authors concluded that since delayed pushing does not increase spontaneous vaginal delivery rates and increases the duration of the second stage of labor and both maternal and neonatal morbidity, immediate pushing may be preferred in this patient population. 

ACOG aims to optimize postpartum care 

American College of Obstetricians and Gynecologists. ACOG Committee Opinion No. 736. Optimizing postpartum care. Obstet Gynecol. 2018;131:e140-e150. 

In May 2018, ACOG released "Optimizing postpartum care," a committee opinion that proposes a new model of comprehensive postpartum care focused on improving both short- and long-term health outcomes for women and infants. (This replaces the June 2016 committee opinion No. 666.) Described as "the fourth trimester," the postpartum period is a critical transitional period in which both pregnancy-related and pre-existing conditions may affect maternal, neonatal, and family status; half of pregnancy-related maternal deaths occur during the postpartum period.⁶ 

The postpartum visit: Often a lost opportunity 

ACOG cites that up to 40% of women in the United States do not attend their postpartum visit.6 Many aspects of the postpartum visit, including follow-up for chronic diseases, mental health screening, and contraceptive counseling, provide opportunities for acute intervention as well as establishment of healthy behaviors. Some studies have shown that postpartum depression, breastfeeding, and patient satisfaction outcomes improve as a result of postpartum engagement. 

Continue to: ACOG's recommendations...

ACOG's recommendations 

Ongoing process. ACOG's first proposed change concerns the structure of the postpartum visit itself, which traditionally has been a single visit with a provider at approximately 6 weeks postpartum. Postpartum care plans actually should be started before birth, during regular prenatal care, and adjusted in the hospital as needed so that the provider can educate patients about the issues they may face and resources they may need during this time. This prenatal preparation hopefully will encourage more patients to attend their postpartum visits. 

Increased provider contact. Another proposed change is that after delivery, the patient should have contact with a provider within the first 3 weeks postpartum. For high-risk patients, this may involve an in-person clinic visit as soon as 3 to 10 days postpartum (for hypertensive disorders of pregnancy) or at 1 to 2 weeks (for postpartum depression screening, incision checks, and lactation issues). For lower-risk patients, a phone call may be appropriate and/or preferred. Ongoing follow-up for all patients before the final postpartum visit should be individualized. 

Postpartum visit and care transition. ACOG recommends a comprehensive postpartum visit at 4 to 12 weeks to fully evaluate the woman's physical, social, and psychologic well-being and to serve as a transition from pregnancy care to well-woman care. This is a large order and includes evaluation of the following: 

• mood and emotional well-being 
• infant care and feeding 
• sexuality, contraception, and birth spacing 
• sleep and fatigue 
• physical recovery from birth 
• chronic disease management and transition to primary care provider 
• health maintenance 
• review of labor and delivery course if needed 
• review of risks and recommendations for future pregnancies. 

After these components are addressed, it is expected that the patient will be transitioned to a primary care provider (who may continue to be the ObGyn, as appropriate) to coordinate her future care in the primary medical home.  

Useful resource for adopting new paradigm 

ACOG's recommendations are somewhat daunting, and these changes will require education and resources, a significant increase in obstetric provider time and effort, and consideration of policy change regarding such issues as parental leave and postpartum care reimbursement. As a start, ACOG has developed an online aid for health care providers called "Postpartum toolkit" (https://www.acog.org/About-ACOG/ACOG-Departments/Toolkits-for-Health-Care-Providers/Postpartum-Toolkit), which provides education and resources for all steps in the process and can be individualized for each practice and patient.⁷  
 

Expert Commentary 

Sriprasert I, Hodis HN, Karim R, et al. Differential effect of plasma estradiol on subclinical atherosclerosis progression in early versus late postmenopause. J Clin Endocrinol Metab. 2019;104:293-300. doi:10.1210/jc.2018-01600.

In 2016, the primary findings of the Early versus Late Intervention Trial with Estradiol (ELITE) demonstrated that oral E2 administered to women who were less than 6 years postmenopause slowed progression of subclinical atherosclerosis as assessed by carotid artery intima-media thickness (CIMT), while it had no effect in women who were at least 10 years postmenopause.¹

That trial included 643 healthy women without cardiovascular disease who at enrollment had a median age of 55.4 years in the early postmenopause group (median 3.5 years since menopause) and 63.6 years in the late postmenopause group (median 14.3 years since menopause). The study medications were oral estradiol 1 mg daily plus progesterone vaginal gel for women with a uterus or placebo and placebo gel for a median of 5 years.

The investigators found also that, in contrast with CIMT, cardiac computed tomography (CT) measures of atherosclerosis did not differ significantly between the estradiol and placebo groups, regardless of age.¹

Posttrial data analysis revealed a new finding

In a secondary analysis of data from the ELITE trial, Sriprasert and colleagues dug deeper to assess the impact of plasma E2 levels on progression of subclinical atherosclerosis.²

Among 596 women (69.6% white non-Hispanic, 8.7% black, 13.3% Hispanic, and 8.4% Asian/Pacific Islander), E2 levels were available in 248 women in early postmenopause (mean age, 54.7 years) and 348 women in late postmenopause (median age, 63.6 years).

For women in the estradiol-treated group, mean E2 levels during the trial as well as change of E2 levels from baseline were significantly higher in the early postmenopause group than in the late postmenopause group, even though both groups had similar adherence based on pill count. For those in the placebo group, mean E2 levels and change of E2 levels from baseline were equivalent in early and late menopause.

In the E2-treated group and the placebo group combined, the mixed effects analysis of the CIMT progression rate (based on the mean E2 level during the trial) demonstrated that a higher level of E2 was inversely associated with the CIMT progression rate in early postmenopausal women (beta coefficient = -0.04 [95% confidence interval (CI), -0.09 to -0.001] μm CIMT per year per 1 pg/mL estradiol; P = .04). However, a higher level of E2 was positively associated (beta coefficient = 0.063 [95% CI, 0.018 to 0.107] μm CIMT per year per 1 pg/mL estradiol; P = .006) with CIMT progression rate in the late postmenopausal women.

Continue to: Bottom line...

Bottom line. E2 levels resulting from administration of oral estradiol were inversely associated with atherosclerosis progression in women in early menopause, but they were positively associated with progression in late postmenopause participants.

Expert Commentary 

Sriprasert I, Hodis HN, Karim R, et al. Differential effect of plasma estradiol on subclinical atherosclerosis progression in early versus late postmenopause. J Clin Endocrinol Metab. 2019;104:293-300. doi:10.1210/jc.2018-01600.

In 2016, the primary findings of the Early versus Late Intervention Trial with Estradiol (ELITE) demonstrated that oral E2 administered to women who were less than 6 years postmenopause slowed progression of subclinical atherosclerosis as assessed by carotid artery intima-media thickness (CIMT), while it had no effect in women who were at least 10 years postmenopause.¹

That trial included 643 healthy women without cardiovascular disease who at enrollment had a median age of 55.4 years in the early postmenopause group (median 3.5 years since menopause) and 63.6 years in the late postmenopause group (median 14.3 years since menopause). The study medications were oral estradiol 1 mg daily plus progesterone vaginal gel for women with a uterus or placebo and placebo gel for a median of 5 years.

The investigators found also that, in contrast with CIMT, cardiac computed tomography (CT) measures of atherosclerosis did not differ significantly between the estradiol and placebo groups, regardless of age.¹

Posttrial data analysis revealed a new finding

In a secondary analysis of data from the ELITE trial, Sriprasert and colleagues dug deeper to assess the impact of plasma E2 levels on progression of subclinical atherosclerosis.²

Among 596 women (69.6% white non-Hispanic, 8.7% black, 13.3% Hispanic, and 8.4% Asian/Pacific Islander), E2 levels were available in 248 women in early postmenopause (mean age, 54.7 years) and 348 women in late postmenopause (median age, 63.6 years).

For women in the estradiol-treated group, mean E2 levels during the trial as well as change of E2 levels from baseline were significantly higher in the early postmenopause group than in the late postmenopause group, even though both groups had similar adherence based on pill count. For those in the placebo group, mean E2 levels and change of E2 levels from baseline were equivalent in early and late menopause.

In the E2-treated group and the placebo group combined, the mixed effects analysis of the CIMT progression rate (based on the mean E2 level during the trial) demonstrated that a higher level of E2 was inversely associated with the CIMT progression rate in early postmenopausal women (beta coefficient = -0.04 [95% confidence interval (CI), -0.09 to -0.001] μm CIMT per year per 1 pg/mL estradiol; P = .04). However, a higher level of E2 was positively associated (beta coefficient = 0.063 [95% CI, 0.018 to 0.107] μm CIMT per year per 1 pg/mL estradiol; P = .006) with CIMT progression rate in the late postmenopausal women.

Continue to: Bottom line...

Bottom line. E2 levels resulting from administration of oral estradiol were inversely associated with atherosclerosis progression in women in early menopause, but they were positively associated with progression in late postmenopause participants.

Expert Commentary 

Sriprasert I, Hodis HN, Karim R, et al. Differential effect of plasma estradiol on subclinical atherosclerosis progression in early versus late postmenopause. J Clin Endocrinol Metab. 2019;104:293-300. doi:10.1210/jc.2018-01600.

In 2016, the primary findings of the Early versus Late Intervention Trial with Estradiol (ELITE) demonstrated that oral E2 administered to women who were less than 6 years postmenopause slowed progression of subclinical atherosclerosis as assessed by carotid artery intima-media thickness (CIMT), while it had no effect in women who were at least 10 years postmenopause.¹

That trial included 643 healthy women without cardiovascular disease who at enrollment had a median age of 55.4 years in the early postmenopause group (median 3.5 years since menopause) and 63.6 years in the late postmenopause group (median 14.3 years since menopause). The study medications were oral estradiol 1 mg daily plus progesterone vaginal gel for women with a uterus or placebo and placebo gel for a median of 5 years.

The investigators found also that, in contrast with CIMT, cardiac computed tomography (CT) measures of atherosclerosis did not differ significantly between the estradiol and placebo groups, regardless of age.¹

Posttrial data analysis revealed a new finding

In a secondary analysis of data from the ELITE trial, Sriprasert and colleagues dug deeper to assess the impact of plasma E2 levels on progression of subclinical atherosclerosis.²

Among 596 women (69.6% white non-Hispanic, 8.7% black, 13.3% Hispanic, and 8.4% Asian/Pacific Islander), E2 levels were available in 248 women in early postmenopause (mean age, 54.7 years) and 348 women in late postmenopause (median age, 63.6 years).

For women in the estradiol-treated group, mean E2 levels during the trial as well as change of E2 levels from baseline were significantly higher in the early postmenopause group than in the late postmenopause group, even though both groups had similar adherence based on pill count. For those in the placebo group, mean E2 levels and change of E2 levels from baseline were equivalent in early and late menopause.

In the E2-treated group and the placebo group combined, the mixed effects analysis of the CIMT progression rate (based on the mean E2 level during the trial) demonstrated that a higher level of E2 was inversely associated with the CIMT progression rate in early postmenopausal women (beta coefficient = -0.04 [95% confidence interval (CI), -0.09 to -0.001] μm CIMT per year per 1 pg/mL estradiol; P = .04). However, a higher level of E2 was positively associated (beta coefficient = 0.063 [95% CI, 0.018 to 0.107] μm CIMT per year per 1 pg/mL estradiol; P = .006) with CIMT progression rate in the late postmenopausal women.

Continue to: Bottom line...

Bottom line. E2 levels resulting from administration of oral estradiol were inversely associated with atherosclerosis progression in women in early menopause, but they were positively associated with progression in late postmenopause participants.