Factors Associated With the Publication of Registered Randomized Controlled Trials in Obstetrics [18K

Abstract

INTRODUCTION: In an effort to improve transparency, as part of the Food and Drug Amendment Act of 2007, Congress mandated that randomized clinical trials (RCTs) be registered on clinicaltrials.gov. The aim of this review was to identify factors associated with the publication of registered RCTs on obstetrical topics. METHODS: Study data was collected from the National Institutes of Health (NIH) database at clinicaltrials.gov. The database was queried by NIH recommended obstetrical terms for trials with a registered start date from 2009-2013. Self-reported descriptive data of the registered studies was abstracted. PubMed was interrogated for all self-identified completed projects for publication information by September 2018. RESULTS: Over the five-year study period, 412 obstetrical RCTs were registered and 266 (65%) were completed. Among the completed RCTs, 166 (62%) were published in a MEDLINE indexed journal. Compared to projects without publication, projects that resulted in publication had a larger sample size (median 179 vs 97.5 P<.005), and were more likely to be multicenter studies (P <.022). There was no difference in publication rates between United States-based or international studies (P<.56). Industry-funded projects were less likely to be published than those funded by the NIH (P<.017). Studies involving drug, device or procedure interventions were more likely to result in publication (P<.014). CONCLUSION: About 2 in 3 completed randomized control trials on obstetrical topics are published within five-years of being completed. Interventions may be necessary to increase the completion and publication rate of registered RCTs.