Pregnant or breastfeeding women routinely use medication for everything from the common cold to epilepsy. Are the medications safe during pregnancy? Effective? Patients and their doctors can’t be certain. And there isn’t adequate research to consult. Concerns about safety, liability and ethics have made clinical trials for these women a rarity.
But a task force convened by the National Institute of Child Health and Human Development aims to change this situation. Its goal: to overcome the dearth of information about which medications are safe and effective for pregnant and breastfeeding women. Congress charged the task force with identifying knowledge gaps and recommending changes that will spur research that includes pregnant or breastfeeding women.
The task force’s recently released report includes recommendations to:
- Remove barriers that keep pregnant or breastfeeding women from participating in research; incorporate them into the research agenda
- Update the requirement that both the pregnant woman and the baby’s father consent to the trial. The change would require only the mother’s consent
- Create a system to reduce or cover sponsors’ liability
- Streamline current data sources and mine them to provide a foundation for future research.
The report also notes the need for more public education to “alter the cultural assumptions” that hinder research for pregnant or breastfeeding women. It calls for a “cultural shift” to emphasize the public health benefits of having a knowledge base to inform medical decision making for this population.
The Department of Health and Human Services has until December to decide which of the recommendations it will implement. Secretary Alex Azar also has the option to further the task force’s work by extending its charter for another two years.