Patient Perceptions of Clinical Research in Pregnancy
ACOG ePoster. Clapp M. Apr 27, 2018; 211653
Mark Clapp
Mark Clapp
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Abstract
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Introduction: In 2017, the Federal Policy for the Protection of Human Subjects removed pregnant women as a “vulnerable” population and the associated restrictions on research. Little is known about the women's attitudes toward research in pregnancy. Our goal was to understand the types of trials in which pregnant women would enroll and to identify barriers to participation.

Methods: An anonymous survey was distributed by non-clinical staff on the postpartum units to women who delivered a viable, liveborn fetus from June-September 2017. The survey was designed, tested, and distributed at a single academic center with IRB approval.


Results: 100 of the 265 distributed surveys were returned (38%). Of participants, 34% had previously participated in research, and 43% would consider participating in pregnancy. Women were unlikely to participate in trials with medications with no data in pregnancy (80%), experimental vaccinations (68%), trials with a placebo (45%), or research with unknown effects on breastfeeding (79%). Women were willing to participate in studies with more ultrasounds (51%) and additional blood work (60%) prenatally. Women were more accepting of trials involving infection prevention (55%) and pain control (60%) in labor. The effects of demographic variables were assessed on a woman's likelihood of participation in pregnancy using a univariate logistic regression; race, education, physician visits in the prior year, and employment type were statistically significant (p
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