Motivations and demographic differences in pregnant individuals in the decision to participate in research.

PURPOSE: Although many patients agree to participate in research studies, many decline. The decision of whether or not to participate is especially complex in pregnant individuals as they may be concerned about both themselves and the fetus. We sought to understand patient reasoning for and demographic associations with participation in a trial surrounding the utility of epidural preservative-free morphine after successful vaginal delivery.

METHODS: We conducted a survey-based study in which parturients were approached within 36 hr after delivery to complete a survey assessing reasons for why they participated or not in the original trial. The survey also included self-reported demographics. Survey responses were categorized as follows: active participation, passive participation, ambivalence, aversion, miscommunication, clinical difficulty, unwilling to receive placebo, and screening failures.

RESULTS: The survey response rate was 47%. Having a bachelor's degree or higher was associated with participating in the study (odds ratio [OR], 1.97; 95% confidence interval [CI], 1.07 to 3.64; P = 0.03). Race and ethnicity were not predictive of participation. Participants who self-identified as Black were more likely to select reasons of aversion for why they did not participate in the trial (OR, 2.6; 95% CI, 1.00 to 6.75; P = 0.05). Seventy-three percent of participants who self-identified as Black and declined to participate selected aversion, compared with 31% of those who self-identified as non-Black. Additionally, 71% of participants who self-identified as Hispanic and declined to participate selected aversion, compared with 32% of those who self-identified as non-Hispanic.

CONCLUSIONS: These findings can help identify areas for improvement of participation of pregnant individuals in research studies. Demographic associations may influence participation and reasons for participation.