Reproduction Abstracts

Pregnant women with hyperemesis gravidarum (HG) and their health care providers must make difficult decisions about their health every day. These difficult decisions are compounded by a widespread lack of evidence on the dosing, safety, and efficacy of potential treatments or concomitant medications. Pregnancy is not a single condition. It leads to physiological changes across different trimesters that can affect how the body interacts with and metabolizes medications, including cardiovascular, respiratory, gastrointestinal, metabolic, and renal system changes. There is international consensus that the lack of data about the effects of medications during pregnancy stems from a reluctance to include pregnant women in clinical research. This reluctance is heightened by the complexities of HG. A recent report from the National Academies of Science, Engineering and Medicine (NASEM), Clinical Research with Pregnant and Lactating Populations: Overcoming Real and Perceived Liability Risks, debunks one of the underlying bases for the reluctance to include pregnant women in research, fear of legal liability, and provides a framework for conducting clinical research with pregnant women that minimizes harm. The report addresses the major obstacles to including pregnant women in research: the culture of exclusion; challenges in recruiting participants; lack of expertise in research involving pregnant women; reputational risk; cost and complexity of trials; and the lack of financial incentives. To address these obstacles, the report recommends improving FDA and HHS guidance for clinical trials involving new drugs and drugs already on the market, providing additional incentives for conducting the research and protections for researchers and participants in the research. This research is essential to providing better outcomes for women suffering from HG and their offspring. They deserve nothing less.

Keywords: Hyperemesis Gravidarum, Pregnancy, Clinical Trials, NASEM, FDA, NIH