Regulatory and clinical trial exclusion of pregnant women: economic implications for preventive interventions in low-income countries.

Abstract

Introduction: Preventive interventions during pregnancy represent a high-return investment, and some of the most cost-effective strategies because they help prevent diseases, reducing the cost for hospital treatment, and neonatal intensive care treatments, complications, and long-term health problems for both mother and child. We searched PubMed, Google, ClinicalTrials.gov, the International Clinical Trials Registry Platform, and Ministry of Health websites from low-income countries (LICs) to identify clinical trials and regulatory documents governing pregnancy-related research.

Areas covered: Limited research capacity in LICs restrict the generation of robust clinical evidence for preventive interventions during pregnancy. Consequently, pregnant women may receive routine care based on limited evidence, while uncertainty remains regarding treatment effectiveness, safety, and economic value. This evidence gap may compromise the reliability of cost-effectiveness and cost-benefit analyses by relying on incomplete or non-contextualized clinical and economic data.

Expert opinion: Strengthening maternal health research requires responsible inclusion of pregnant women in clinical trials, integration of health economic evaluation into research designs, regulatory harmonization, and sustainable data systems. Improving the quality of clinical and economic evidence is essential to support efficient resource allocation, reduce maternal and neonatal health disparities, and ensure that preventive interventions achieve their full public health and economic potential.