NIH Research Festival
Scientists face several procedural and ethical challenges trying to prevent pregnancy in research where there is potential fetal harm from study interventions, and where the early-withdrawal of women who become pregnant can compromise study data. We explored trends associated with 25 pregnancies that occurred among 1,353 female subjects enrolled in 17 protocols from October 2009 – June 2017. We also conducted a comprehensive literature review covering 2010 – 2016 to explore: (1) the regulatory and ethical framework underpinning enrollment of women in clinical trials; (2) industry practices regarding contraception and pregnancy during clinical trials; (3) challenges to pregnancy prevention in clinical trials; (4) guidance on informed consent language and conveying risks as well as birth control information to women; (5) counseling interventions that may benefit enrollee understanding about the fetal risks of study drugs, as well as the efficacy and proper use of various contraceptive methods. No definitive contraceptive-method picture emerged from our data, but pregnancies occurred when contraceptives – whatever method – were used inconsistently or incorrectly. Our literature review revealed that it is particularly challenging to prevent pregnancy in clinical trials in resource-poor environments where limited education, traditional gender role beliefs, and cultural norms often run counter to the aims of birth control. Male partner involvement and relationship dynamics are crucial to understanding pregnancy among female study enrollees. In future, it would be particularly useful to gather information about the socio-cultural milieu of the female enrollees so we could better tailor pregnancy counseling and the provision of contraceptive methods to their needs.
Scientific Focus Area: Research Support Services
This page was last updated on Friday, March 26, 2021