Reasons for and associated characteristics with early study termination: Analysis of ClinicalTrials.gov data on pregnancy topics

Abstract

Background Prematurely terminated studies are unlikely to provide data for evidence-based practice. There has been no systematic review on premature study termination on pregnancy-related research. Purpose This study investigated the reasons why studies on pregnancy topics are terminated and the associated characteristics with early termination. Methods A total of 3,623 studies (332 terminated and 3,291 completed) were retrieved from ClinicalTrials.gov registry. Reasons for termination were grouped into four categories, including accrual difficulty, research operation issues, data-related recommendations, and external factors. Study characteristics were statistically compared between terminated and completed studies. Findings Accrual difficulty (44.6%) and research operation issues (21.4%) were most frequently cited reasons for termination. Study design characteristics of intervention, randomization, masking, treatment and drug trial, and low funding from federal agencies were significantly associated with early termination. Discussion Population tailored subject recruitment strategies, scientifically sound research protocols, and well-planned research operations may mitigate premature study termination.