Factors influencing the participation of pregnant and lactating women in clinical trials: A mixed-methods systematic review.
Mridula ShankarAlya HazfiariniRana Islamiah ZahrohJoshua Peter VogelAnnie R A McDougallPatrick CondronShivaprasad S GoudarYeshita V PujarManjunath S SomannavarUmesh S CharantimathAnne AmmerdorfferSara RushwanAhmet Metin GülmezogluMeghan A BohrenPublished in: PLoS medicine (2024)
This systematic review highlights diverse factors across multiple levels and stakeholders affecting the participation of pregnant and lactating women in clinical trials. By linking identified factors to frameworks of behaviour change, we have developed theoretically informed strategies that can help optimise pregnant and lactating women's engagement, participation, and trust in such trials.