Most women use medication during pregnancy. Yet, selecting appropriate drugs and doses is challenging. In a new The Lancet article, physicians and researchers from the Radboud university medical center, Maastricht UMC+, Imperial College London, and the University of Liverpool introduce a shared decision-making approach combining ethical principles and a pregnant woman's values with existing evidence. They use the example of sertraline, a commonly prescribed antidepressant in pregnancy, to illustrate the advocated decision-making process.
Although pregnant women often need medication, data on drug safety and efficacy in pregnancy remains limited. Historically seen as vulnerable research subjects, pregnant women have been widely excluded from drug development and testing. The thalidomide scandal of the 1950s-60s, which caused severe birth defects in thousands of children, exposed the potential risks of administering medications to pregnant women without adequate evidence, prompting a highly cautious approach to prescribing drugs during pregnancy. However, withholding medication from a pregnant woman may indirectly harm both her and her child by compromising the mother's health and well-being. Additionally, pregnant women may not receive balanced information about a medication's risks and benefits or be fully involved in treatment decisions, potentially leading to suboptimal decision-making and avoidable harm.
'The medical community urgently needs ethical and actionable models to help balance the benefits and risks of medications for individual pregnant patients and fetuses,' says lead author Charlotte Koldeweij. The article outlines key ethical principles and provides practical steps to assist clinicians and pregnant women in making shared decisions on appropriate drug use and dosage, considering both available evidence and a woman's personal values. This approach is exemplified for sertraline, an antidepressant that may be prescribed during pregnancy. Promoting the active participation of pregnant women in decisions about their treatment could help shift societal perceptions of their vulnerability and increase their inclusion in medical research, helping to address the current evidence gap.
This work is part of project MADAM (Model Adjusted Doses for All Mothers). In collaboration with the Dutch Teratology Information Service Lareb Moeders van Morgen, which compiles available information on medication safety during pregnancy and breastfeeding, researchers leverage virtual pregnancy models and insights from a multidisciplinary committee of experts and patients to develop tailored dose recommendations for pregnant women and fetuses for widely used medications. The project is supported by a grant from the Bill & Melinda Gates Foundation. 'Our goal is to establish and promote the use of model-informed, pregnancy-adjusted doses, which requires gaining acceptance from clinicians and pregnant women,' states project leader Saskia de Wildt.
About the publication
This article is published in The Lancet: Striving for balance in decisions on antenatal pharmacotherapy - Charlotte Koldeweij, Verna AAM Jans, Catriona Waitt, Rick Greupink, Kim LHE Vanden Auweele, Bryony D Franklin, Hubertina CJ Scheepers, Saskia N de Wildt.
Post-embargo link to the publication
https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(24)02069-5/fulltext
