October 16, 2019

The Unexpected Home for NIH’s Maternal Health Research

By Emily Ortman, SWHR Communications Director

In the ongoing quest to ensure women’s inclusion in medical research, many stakeholders consider research involving pregnant and lactating women as the next step forward. At the National Institutes of Health (NIH), these efforts are being led by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).

Although not immediately obvious from the institute’s name, NICHD’s mission and strategic plan include a significant focus on advancing women’s health, said Lisa Kaeser, director of NICHD’s Office of Legislation and Public Policy. NICHD ranks 5th out of the 27 NIH institutes and centers in funding for women’s health.

During SWHR’s recent policy committee meeting, Kaeser spoke about NICHD’s research and programs related to maternal health, pregnancy, and breastfeeding. In fiscal year 2018, NICHD funded 57% of NIH maternal health research, 40% of pregnancy research, and 24% of breastfeeding research.

Before 2017, however, NIH did not track research funding for these three areas in its Research, Condition and Disease Categorization (RCDC) database. That changed thanks to an NICHD-led initiative called the Task Force on Research Specific to Pregnant Women and Lactating Women (PRGLAC). Establishing these new categories was one of the early achievements of the task force, which was established by the 21st Century Cures Act to advise the secretary of Health and Human Services (HHS) regarding gaps in knowledge on safe and effective therapies for pregnant and lactating women.

“[PRGLAC] has been one of the best policy-based collaborations I’ve ever been involved in in my very long time here in Washington,” said Kaeser, who serves as the task force’s executive secretary.

She said the idea for PRGLAC stemmed from conversations in the medical and patient communities about the need to address the fact that pregnant women take medications despite the lack of information on whether these drugs are safe or effective for them and their pregnancies. “It was astonishing that people didn’t know if they were getting the right dose or if the dose was no longer as effective for them,” Kaeser said.

The task force held four open meetings to gather information and then submitted a report in September 2018 to the HHS secretary with 15 major recommendations regarding research and development of safe and effective therapies for pregnant and lactating women. Read SWHR’s statement in support of the PRGLAC report.

One of the key takeaways from the report is the need to change the culture around taking medication during pregnancy. Part of that effort will focus on helping people realize that sometimes not taking medications during pregnancy might actually be more harmful than taking them, Kaeser said. The task force is now working on guidance to assist in the implementation of its recommendations, with its final report due in February 2020.

Another way NICHD is working to address the lack of data on pregnant and lactating women is through it online pregnancy registry, PregSource.

“We realized we didn’t have a full picture of the range of experiences in a normative pregnancy,” Kaeser said, so the registry collects information directly from women about their pregnancy experiences as well as provides women access to useful resources. SWHR received the 2017 NICHD Director’s Award for its participation as a partner agency in PregSource.

Another immediate outcome from PRGLAC, Kaeser said, was the addition of a medications tracker to PregSource so pregnant women can indicate what drugs they are taking. “It’s so much broader than we realized,” she said of the tracker results, with the different types of medicines and dosages “all over the map.”

Kaeser said NICHD is now working on creating a PregSource mobile app as well as a professional portal so researchers and clinicians can access deidentified data that show how many women are taking what drugs, with the goal of helping researchers design better studies.

NICHD is also leading NIH research focused on maternal mortality and morbidity, which has received much attention in recent years after reports showed that an estimated 700 women die from pregnancy-related deaths each year in the U.S., and approximately 50,000 women experience life-threatening complications. NICHD’s work in these areas includes conducting studies on the conditions most likely to cause maternal deaths during pregnancy and the postpartum period.

Kaeser noted that much of NICHD’s maternal health research is funded through three research networks: Maternal-Fetal Medicine Units (MFMU) Network, Global Network for Women’s and Children’s Health Research, and the OPRC Network (formerly the Obstetric-Fetal Pharmaceutical Research Units Network).

Finally, Kaeser said NICHD is discussing how to conduct research in women with physical and intellectual disabilities who are also pregnant. “No one knows about women who have a physical disability and a pregnancy,” she said. “There is just nothing out there on that.”

To learn more about NICHD’s work, review the institute’s new strategic plan.