Fighting for Inclusion of Pregnant and Breastfeeding Women in Research



By Kathryn G. Schubert, MPP, SWHR President and CEO

In June 2013, I was 8 months pregnant with my third child and shepherding high-risk obstetricians around Capitol Hill for meetings with members of Congress and their staff. We were advocating for additional support for National Institutes of Health (NIH) research in pregnant women to improve clinical practice and health outcomes. 

I was suffering from a sinus infection and shared with my fellow advocates that I couldn’t get my OB-GYN or my primary care practitioner to prescribe an antibiotic because I was pregnant. Yet with each of my previous pregnancies I had sinus infections and was able to take antibiotics to clear them up. 

Although the obstetricians with me on the Hill had differing opinions on whether I should take an antibiotic, they all agreed that we just don’t know enough about medications taken in pregnancy because pregnant women and breastfeeding women are largely excluded from medical research. 

When you consider the number of women of reproductive age in the United States and the proportion of them who are pregnant or breastfeeding at any given time, that’s a large chunk of the population that hasn’t been studied to ensure safety and efficacy of medications. Obviously my sinus infection was not life-threatening, but many women have chronic health conditions that require medication for management or treatment while they are pregnant, or they may become sick or injured while they are pregnant. 

Our conversations that day on Capitol Hill led to discussions among like-minded advocacy organizations such as the American College of Obstetricians and Gynecologists, March of Dimes, and American Academy of Pediatrics. Then in 2014, while working at the Society for Maternal-Fetal Medicine (SMFM), I helped to create the Coalition to Advance Maternal Therapeutics (CAMT), which advocated for the establishment of a federal task force on research in pregnant and breastfeeding women. This coalition continues to drive policy change to further the safety and efficacy of medications used in pregnancy and breastfeeding.

On November 10, 2020, I was honored to be named Advocate of the Year by Women in Government Relations for spearheading these efforts to advocate for the creation of the federal Task Force on Research Specific to Pregnant Women and Lactating Women (PRGLAC). I am very proud to be a part of this work and to have played a role in the coalition building and broad organizational support that it earned. 

I am heartened by the dedication of the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) in its coordinating role of the PRGLAC Task Force, as well as the participation of representatives of the Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC), clinicians, researchers, patients, and industry. It is a testament to the critical nature of this work that such a diverse group of stakeholders has come together to further these shared goals. 

But we’re not even close to being done yet. We have a great opportunity right now to advocate for the implementation of the PRGLAC Task Force’s 15 recommendations designed to address obstacles to the inclusion of pregnant women and breastfeeding women in research. SWHR is dedicated to ensuring the appropriate inclusion of pregnant and breastfeeding women in research, and we will continue to support the PRGLAC’s work and advocate for progress and equity in clinical research. 

We need robust funding and increased engagement of researchers in this space, dedicated efforts by clinical societies to educate their members, commitment from industry to advancing inclusion and removing barriers to participation in research, and more women willing to participate. 

Maternal health in this country has been at a crisis point for quite some time. According to the CDC, about two-thirds of deaths related to pregnancy are preventable. Beyond this, the disparities between white women and women of color are wide. Black women are three times more likely to die from a pregnancy-related complication in the U.S. than white women. Hispanic and Native American women are also more likely to experience death related to pregnancy than white women. 

Inclusion in research is one foundational way that we can further improve the health of mothers in the U.S., along with key policies like continuing Medicaid coverage through one year postpartum and creating maternal mortality review committees and perinatal quality collaboratives. 

In addition, complications of pregnancy can result in issues for women and their babies later in life. For instance, women who have high blood pressure (hypertension) and preeclampsia during pregnancy are at an increased risk for cardiovascular disease later on in life. This could present as coronary heart disease, stroke, thromboembolic disease, heart failure, or arrhythmias. There is a huge opportunity for women, their families, clinicians, researchers, and industry to come together to work toward a better understanding of what happens during pregnancy and how to improve a woman’s health not only during that time period, but throughout her life. 

SWHR was founded 30 years ago because women were being excluded from most medical research. While we have made great strides so that women are now routinely included in clinical trials, there are still critical areas of need: inclusion of pregnant women and breastfeeding women and inclusion of more diverse populations of women. 

With this blog, we’re kicking off a series of activities that will highlight maternal and infant health. As the chief medical officers of their families, women must be empowered to ask the right questions, to arm themselves with science-based information, and to ensure optimal health for themselves and their families. 

As we close out 2020 and enter a new year with a new administration (including the country’s first female vice president), with more female members of Congress than ever before, and with a continuing public health pandemic, there is no better time for us to come together in the women’s health community to advocate for broader inclusion. The roadmap is there, we just have to follow it. 

By Kathryn G. Schubert, MPP, SWHR President and CEO

In June 2013, I was 8 months pregnant with my third child and shepherding high-risk obstetricians around Capitol Hill for meetings with members of Congress and their staff. We were advocating for additional support for National Institutes of Health (NIH) research in pregnant women to improve clinical practice and health outcomes. 

I was suffering from a sinus infection and shared with my fellow advocates that I couldn’t get my OB-GYN or my primary care practitioner to prescribe an antibiotic because I was pregnant. Yet with each of my previous pregnancies I had sinus infections and was able to take antibiotics to clear them up. 

Although the obstetricians with me on the Hill had differing opinions on whether I should take an antibiotic, they all agreed that we just don’t know enough about medications taken in pregnancy because pregnant women and breastfeeding women are largely excluded from medical research. 

When you consider the number of women of reproductive age in the United States and the proportion of them who are pregnant or breastfeeding at any given time, that’s a large chunk of the population that hasn’t been studied to ensure safety and efficacy of medications. Obviously my sinus infection was not life-threatening, but many women have chronic health conditions that require medication for management or treatment while they are pregnant, or they may become sick or injured while they are pregnant. 

Our conversations that day on Capitol Hill led to discussions among like-minded advocacy organizations such as the American College of Obstetricians and Gynecologists, March of Dimes, and American Academy of Pediatrics. Then in 2014, while working at the Society for Maternal-Fetal Medicine (SMFM), I helped to create the Coalition to Advance Maternal Therapeutics (CAMT), which advocated for the establishment of a federal task force on research in pregnant and breastfeeding women. This coalition continues to drive policy change to further the safety and efficacy of medications used in pregnancy and breastfeeding.

On November 10, 2020, I was honored to be named Advocate of the Year by Women in Government Relations for spearheading these efforts to advocate for the creation of the federal Task Force on Research Specific to Pregnant Women and Lactating Women (PRGLAC). I am very proud to be a part of this work and to have played a role in the coalition building and broad organizational support that it earned. 

I am heartened by the dedication of the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) in its coordinating role of the PRGLAC Task Force, as well as the participation of representatives of the Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC), clinicians, researchers, patients, and industry. It is a testament to the critical nature of this work that such a diverse group of stakeholders has come together to further these shared goals. 

But we’re not even close to being done yet. We have a great opportunity right now to advocate for the implementation of the PRGLAC Task Force’s 15 recommendations designed to address obstacles to the inclusion of pregnant women and breastfeeding women in research. SWHR is dedicated to ensuring the appropriate inclusion of pregnant and breastfeeding women in research, and we will continue to support the PRGLAC’s work and advocate for progress and equity in clinical research. 

We need robust funding and increased engagement of researchers in this space, dedicated efforts by clinical societies to educate their members, commitment from industry to advancing inclusion and removing barriers to participation in research, and more women willing to participate. 

Maternal health in this country has been at a crisis point for quite some time. According to the CDC, about two-thirds of deaths related to pregnancy are preventable. Beyond this, the disparities between white women and women of color are wide. Black women are three times more likely to die from a pregnancy-related complication in the U.S. than white women. Hispanic and Native American women are also more likely to experience death related to pregnancy than white women. 

Inclusion in research is one foundational way that we can further improve the health of mothers in the U.S., along with key policies like continuing Medicaid coverage through one year postpartum and creating maternal mortality review committees and perinatal quality collaboratives. 

In addition, complications of pregnancy can result in issues for women and their babies later in life. For instance, women who have high blood pressure (hypertension) and preeclampsia during pregnancy are at an increased risk for cardiovascular disease later on in life. This could present as coronary heart disease, stroke, thromboembolic disease, heart failure, or arrhythmias. There is a huge opportunity for women, their families, clinicians, researchers, and industry to come together to work toward a better understanding of what happens during pregnancy and how to improve a woman’s health not only during that time period, but throughout her life. 

SWHR was founded 30 years ago because women were being excluded from most medical research. While we have made great strides so that women are now routinely included in clinical trials, there are still critical areas of need: inclusion of pregnant women and breastfeeding women and inclusion of more diverse populations of women. 

With this blog, we’re kicking off a series of activities that will highlight maternal and infant health. As the chief medical officers of their families, women must be empowered to ask the right questions, to arm themselves with science-based information, and to ensure optimal health for themselves and their families. 

As we close out 2020 and enter a new year with a new administration (including the country’s first female vice president), with more female members of Congress than ever before, and with a continuing public health pandemic, there is no better time for us to come together in the women’s health community to advocate for broader inclusion. The roadmap is there, we just have to follow it.