The obstetrical research landscape: a cross-sectional analysis of clinical trials from 2007-2020

• Published in: American journal of obstetrics & gynecology MFM 2021-01, Vol.3 (1), p.100253-100253, Article 100253
• Main Authors: Steinberg, Jecca R., Weeks, Brannon T., Reyes, Griselda A., Conway Fitzgerald, Alison, Zhang, Wendy Y., Lindsay, Sarah E., Anderson, Jill N., Chan, Katelyn, Richardson, Michael T., Magnani, Christopher J., Igbinosa, Irogue, Girsen, Anna, El-Sayed, Yasser Y., Turner, Brandon E., Lyell, Deirdre J.
• Format: Article
• Language: English
• Subjects: ClinicalTrials.gov; industry; maternal health; maternal-fetal medicine; National Institutes of Health; obstetrical complications; obstetrical investigations; obstetrical morbidity; obstetrical studies; Original Research; research funding
• ISSN: 2589-9333; 2589-9333
• DOI: 10.1016/j.ajogmf.2020.100253

Obstetrical complications affect more than a third of women globally, but are underrepresented in clinical research. Little is known about the comprehensive obstetrical clinical trial landscape, how it compares with other fields, or factors associated with the successful completion of obstetrical trials. This study aimed to characterize obstetrical clinical trials registered on ClinicalTrials.gov with the primary objective of identifying features associated with early discontinuation and results reporting. This is a cross-sectional study with descriptive, logistic regression and Cox regression analyses of clinical trials registered on ClinicalTrials.gov. Our primary exposure variables were trial focus (obstetrical or nonobstetrical) and trial funding (industry, United States government, or academic). We conducted additional exploratory analyses of other trial features including design, enrollment, and therapeutic focus. We examined the associations of exposure variables and other trial features with 2 primary outcomes: early discontinuation and results reporting. We downloaded data for all studies (N=332,417) registered on ClinicalTrials.gov from October 1, 2007, to March 9, 2020, from the Aggregate Analysis of ClinicalTrials.gov database. We excluded studies with a noninterventional design (n=63,697) and those registered before October 1, 2007 (n=45,209). A total of 4276 obstetrical trials (1.9%) (ie, interventional studies) and 219,235 nonobstetric trials (98.1%) were compared. Among all trials, 2.8% of academic-funded trials, 1.9% of United States government–funded trials, and 0.4% of industry-funded trials focused on obstetrics. The quantity of obstetrical trials increased over time (10.8% annual growth rate). Compared with nonobstetrical trials, obstetrical trials had a greater risk of early discontinuation (adjusted hazard ratio, 1.40; 95% confidence interval, 1.21–1.62; P