The Ubomi Buhle Pregnancy Exposure Registry: A Prospective Cohort Assessing the Safety of Clinical and Medicine Exposures in Pregnancy in South Africa
Year: 2025
Type: preprint
Study design: Observational Study
Abstract: Robust data on risks associated with illnesses and medicines during pregnancy, especially in resource-limited settings, remain scarce. The Ubomi Buhle Pregnancy Exposure Registry (UBPER) in South Africa addresses this gap by establishing a large-scale, prospective surveillance platform linking maternal exposures and pregnancy outcomes in a high HIV-prevalence context. UBPER follows pregnant women from their first antenatal care (ANC) visit through to pregnancy outcome, operating across 17 sentinel public health facilities in three provinces. Approximately 15,000 women, living both with and without HIV, are enrolled annually. Routine clinical information is digitally captured using a harmonised data model by five collaborating research partners. The registry employs a health systems strengthening approach, with structured staff training, systematic data validation, and rigorous data quality processes. Pseudonymised records are pooled in a central repository overseen by a data access committee, ensuring ethical governance and facilitating research on medicine safety in pregnancy. Initial analytical priorities include assessing antiretroviral therapy, HIV prevention products, and vaccines, with flexibility to expand to other therapeutic exposures. By September 2025, 89,439 women had been enrolled, with known outcomes for 70,355 pregnancies and an overall cohort retention of approximately 83% (range 76.4%–89.7% across enrolment sites). The HIV prevalence among participants was 28.5% (range 18.5%–35.9% across enrolment sites). UBPER demonstrates the feasibility of sustained, large-scale pharmacovigilance in pregnancy within routine health systems in sub-Saharan Africa. Findings will inform safer therapeutic use during pregnancy and contribute to global efforts to improve maternal and newborn health outcomes.
Institutions: University of Cape Town, University of the Witwatersrand, Emory University, Emory Global Health Institute, Centers for Disease Control and Prevention, Centers for Disease Control and Prevention, Centers for Disease Control and Prevention, North-West University, University of KwaZulu-Natal
Language: English
Field: Medicine
Domain: Health Sciences
Open Access status: green
OpenAlex ID: W4417105730