What’s driving the drug drought for pregnant and lactating women?
For anyone who has been pregnant, it will come as little surprise that there are few medications approved for use during pregnancy and breastfeeding, even for managing symptoms for conditions as basic as a cold or flu. What may come as a bigger surprise is the extent to which the drug drought extends to health conditions affecting pregnancy and birth, such as postpartum hemorrhage or pre-eclampsia, two of the leading causes of maternal death.
Pregnancy-specific medications rarely progress through the research and development pipelines for multiple reasons, including the absence of public stewardship, chronic underinvestment, and regulatory and market barriers – all underpinned by chronic gender biases. The end result is that pregnant populations are not benefitting from advances in biomedical research.
The AIM Gender study, a collaboration between Nossal’s Gender and Women’s Health Unit at the University of Melbourne, Concept Foundation (Geneva), Jawaharlal Nehru Medical College (Belgaum, India), and Bayero University (Kano, Nigeria), aims to unpack the extent to which gender bias and other factors are affecting the participation of pregnant women in clinical research.
Fresh off the press in PLOS Medicine, our systematic review synthesized research from 27 countries, and found women’s willingness to participate depended on various factors: their perceived risk of the condition vs the intervention benefits and risks, therapeutic optimism, expectations of higher quality care, intimate partner/familial relationship dynamics and trust in medicine and research. We also identified factors operating across other stakeholders along the full spectrum of the research ecosystem. Some that stood out included concerns about women’s bodily autonomy, subjectivities in risk and safety assessments, and reticence from funders.
We also found that perspectives of women and communities from certain regions of the Global South were missing, despite serving as sites for implementation of maternal trials. As a step to overcoming this knowledge gap, we are conducting qualitative research with colleagues at Jawaharlal Nehru Medical College in Belgaum, India, and Bayero University in Kano, Nigeria to understand motivations and fears of women and communities regarding clinical research in pregnancy.
Stay tuned as we analyze these findings to add to the voices and experiences of pregnant women, their families and healthcare providers regarding involvement in clinical research in pregnancy.
Dr Mridula Shankar, is a Postdoctoral Research Fellow in Sexual and Reproductive Health and Rights with Nossal Institute’s Gender and Women’s Health Unit. She has a particular interest in improving understanding of reproductive health behaviours and outcomes.