Clinical drug trial participation: Perspectives of pregnant women and their spouses

Abstract

Objective: This study aimed at investigating the factors influencing clinical drug trial participation by pregnant women and their spouses. Methods: This hospital-based cross-sectional study was conducted at Women’s Hospital, School of Medicine, Zhejiang University, from July to September 2020. A self-administered questionnaire was distributed to pregnant women and their spouses in the maternity ward. The questionnaire consisted of two sections: The first part was aimed at collecting demo-graphic information data while the second part consisted of 10 open-ended questions regarding clinical drug trial knowledges, financial compensation, risk awareness, psycholo-gical impact, and pregnancy outcomes. Results: A total of 206 questionnaires (115 from pregnant women and 91 from their spouses) were included in the statistical analysis. About 50% of pregnant women and their spouses had heard of clinical trials (50.43% vs 49.45%, p=0.888). Compared to their spouses, the proportion of pregnant women who thought that there is a need for the development of drugs during pregnancy was significantly higher (94.78% vs 16.48%, p=0.008). Moreover, a significant number of full-time employed pregnant women believed that clinical drug trials will increase the possibility of disease cure, relative to part-time/not employed pregnant women (98.21% vs 88.13%, p=0.030). Spouses whose education levels were below high school and those whose education level was high school or above exhibited significant differences regarding whether financial compensation will motivate their participation in clinical trials (77.78% vs 58.90%, p=0.044). Pregnant women and their spouses had no significant differences regarding various aspects: drug treatment during pregnancy, clinical trial drugs should be free, the need to increase the protection of pregnant women in clinical trials. Conclusion: Due to fetus-associated concerns, most pregnant women are reluctant to be included in clinical trials. However, pregnant women and their spouses agree that medical treatment should be accessible for illnesses during pregnancy, and clinical drug trials during pregnancy should be performed. The usage of untested or sub-therapeutic drug regimens in clinical practice paradoxically increases the risk for fetuses. When recruiting pregnant volunteers for clinical drug trials, researchers should conduct in-depth consultations and comprehensively inform the pregnant women and their families on the pros and cons of their involvement.