More than six million women are pregnant in the United States in any given year. Over the course of their pregnancies and while breast feeding, more than 90 percent of these women will take at least one medication.
But clinical studies of medications, diseases, and conditions often exclude pregnant and lactating women. This leaves women and their caregivers guessing about how the biological changes caused by pregnancy and childbirth affect the development of diseases and the efficacy and safety of particular treatments.
Those changes can be significant. Pregnancy affects every organ system in the body. For example, pregnant women experience increased heart rates and volume of blood, particularly toward the end of pregnancy.
Seeking to address this issue, a federal task force issued a report in September recommending ways to fill gaps in knowledge and amend research protocols concerning pregnant and lactating women.
The 388-page report called for enrolling significant representations of this population of women in clinical research, increasing the number of studies exploring the safety and effectiveness of therapies used by pregnant and lactating women, and boosting communications and resources to better inform caregivers and women about the specific needs of this population.
The report is the culmination of a provision in the 21st Century Cures Act, passed with bi-partisan support in December 2016.
“The task force report provides a welcome accounting of the gap in knowledge concerning the health care needs of pregnant and lactating women,” said Dr. Carolyn M. Mazure, Director of Women’s Health Research at Yale. “It offers needed guidance to help close that gap and improve the lives of women before and after childbirth.”
However, Dr. Mazure, added, the report underlines just how much work needs to be done to properly inform women and their health care providers about the risks and benefits associated with a given treatment.
“Without randomized controlled trials comparing a therapy to a placebo — a harmless medical treatment with no therapeutic effect — caregivers cannot know how a medicine or treatment may affect a pregnant woman differently,” Mazure said. “Too often, such studies have not been conducted. We must continue to do better.”