Evaluating the Landscape of Maternal Medicine Trials: Pivotal Studies, Policy Impact, Trial Disruptions, and Research Quality in LMICs

Despite the significant burden of maternal morbidity and mortality worldwide, maternal medicine remains under-researched compared to other fields. Understanding the impact of pivotal clinical trials, the reasons for early trial termination, and the quality of maternal drug trials—particularly in low- and middle-income countries (LMICs)—is critical to strengthening evidence-based maternal healthcare. This PhD project will conduct a comprehensive review of maternal medicine trials over the last 20 years, focusing on three key areas: 1. Pivotal Maternal Medicine Trials and Their Policy Impact: - Identifying landmark maternal medicine trials (e.g., those leading to changes in WHO or national clinical guidelines). - Mapping policy changes and clinical practice recommendations to these pivotal trials to assess their real-world influence. 2. Maternal Drug Trials Stopped Early and Reasons for Disruption: - Systematically reviewing clinical trial registries and published literature to quantify how many maternal drug trials were terminated early. - Categorizing reasons for trial discontinuation, including safety concerns, lack of efficacy, recruitment challenges, and funding limitations. 3. Quality and Retractions of Maternal Drug Trials in LMICs: - Evaluating the quality of maternal drug trials conducted in LMICs using standardized trial assessment frameworks (e.g., Cochrane risk of bias tools, CONSORT guidelines). - Analyzing how many trials from LMICs have been retracted and the reasons for retraction (e.g., ethical concerns, data integrity issues, methodological flaws). This research will use systematic review methods, analysis of trial registries (e.g., ClinicalTrials.gov, WHO International Clinical Trials Registry Platform), and bibliometric analysis of maternal medicine publications. It will also include expert consultations with maternal health researchers and policymakers to contextualize findings. Impact: By identifying gaps in maternal medicine research, evaluating the robustness of evidence shaping clinical guidelines, and assessing research quality in LMICs, this project will provide critical insights to improve trial design, funding priorities, and policy translation in maternal health.