作者: Jecca R. Steinberg , Brannon T. Weeks , Griselda A. Reyes , Alison Conway Fitzgerald , Wendy Y. Zhang
DOI: 10.1016/J.AJOGMF.2020.100253
关键词:
摘要: Background Obstetrical complications affect more than a third of women globally, but are underrepresented in clinical research. Little is known about the comprehensive obstetrical trial landscape, how it compares with other fields, or factors associated successful completion trials. Objective This study aimed to characterize trials registered on ClinicalTrials.gov primary objective identifying features early discontinuation and results reporting. Study Design cross-sectional descriptive, logistic regression Cox analyses ClinicalTrials.gov. Our exposure variables were focus (obstetrical nonobstetrical) funding (industry, United States government, academic). We conducted additional exploratory including design, enrollment, therapeutic focus. examined associations 2 outcomes: Results downloaded data for all studies (N=332,417) from October 1, 2007, March 9, 2020, Aggregate Analysis database. excluded noninterventional design (n=63,697) those before 2007 (n=45,209). A total 4276 (1.9%) (ie, interventional studies) 219,235 nonobstetric (98.1%) compared. Among trials, 2.8% academic-funded 1.9% government-funded 0.4% industry-funded focused obstetrics. The quantity increased over time (10.8% annual growth rate). Compared nonobstetrical had greater risk (adjusted hazard ratio, 1.40; 95% confidence interval, 1.21-1.62; P<.0001) similar odds reporting 0.89; 0.72-1.10; P=.19). funders after controlling confounding variables, at lowest (United adjusted 0.23; 0.07-0.69; P=.009; industry reference; academic, 1.04; 0.62-1.74; P=.88). Academic-funded (academic institutions, 0.39; 0.22-0.68; P=.0009; 1.06; 0.53-2.09; P=.87). Conclusion represent only have comparatively poor completion. All stakeholders should commit increasing number improving their dissemination ensure research reflects burden disease advances maternal health.