The Ubomi Buhle Pregnancy Exposure Registry: A Prospective Cohort Assessing the Safety of Clinical and Medicine Exposures in Pregnancy in South Africa

The Ubomi Buhle Pregnancy Exposure Registry: A Prospective Cohort Assessing the Safety of Clinical and Medicine Exposures in Pregnancy in South Africa | Authorea try { document.documentElement.classList.add('js'); } catch (e) { } var _gaq = _gaq || []; _gaq.push(['_setAccount', 'G-8VDV14Y67G']); _gaq.push(['_trackPageview']); (function() { var ga = document.createElement('script'); ga.type = 'text/javascript'; ga.async = true; ga.src = ('https:' == document.location.protocol ? 'https://ssl' : 'http://www') + '.google-analytics.com/ga.js'; var s = document.getElementsByTagName('script')[0]; s.parentNode.insertBefore(ga, s); })(); Skip to main content Preprints Collections Wiley Open Research IET Open Research Ecological Society of Japan All Collections About About Authorea FAQs Contact Us Quick Search anywhere Search for preprint articles, keywords, etc. Search Search ADVANCED SEARCH SCROLL This is a preprint and has not been peer reviewed. Data may be preliminary. 8 December 2025 V1 Latest version Share on The Ubomi Buhle Pregnancy Exposure Registry: A Prospective Cohort Assessing the Safety of Clinical and Medicine Exposures in Pregnancy in South Africa Authors : Ushma Mehta 0000-0002-0032-3171 [email protected] , Diane Lavies 0009-0009-6949-9608 , Thokozile Malaba , Faeezah Patel 0000-0003-1503-2016 , Otty Mhlongo , Karl-Günter-Technau , Michelle J. Groome , … Show All … , Aung Myint , Portia C. Mutevedzi , Diane Morof , Marelize van Wyk-Heath , Mireille Cheyip , Helen Malherbe , Shobna Sawry , Andrew Boulle , Dhayendre Moodley 0000-0003-1849-9631 , Emma Kalk 0000-0001-7706-6866 , and Lee Fairlie Show Fewer Authors Info & Affiliations https://doi.org/10.22541/au.176518106.64624818/v1 204 views 170 downloads Contents Abstract Supplementary Material Information & Authors Metrics & Citations View Options References Figures Tables Media Share 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. Supplementary Material File (pds-25-1042-file001.docx) Download 126.07 KB File (pds-25-1042-file002.docx) Download 1.98 MB Information & Authors Information Version history V1 Version 1 08 December 2025 Copyright This work is licensed under a Non Exclusive No Reuse License. Keywords hiv/aids maternal and child health pharmacovigilance pregnancy exposure registry prospective cohort south africa teratovigilance vaccine safety Authors Affiliations Ushma Mehta 0000-0002-0032-3171 [email protected] University of Cape Town Department of Medicine View all articles by this author Diane Lavies 0009-0009-6949-9608 University of Cape Town Department of Medicine View all articles by this author Thokozile Malaba University of Cape Town School of Public Health View all articles by this author Faeezah Patel 0000-0003-1503-2016 University of the Witwatersrand Johannesburg View all articles by this author Otty Mhlongo KwaZulu-Natal Department of Health View all articles by this author Karl-Günter-Technau University of the Witwatersrand Johannesburg View all articles by this author Michelle J. Groome University of the Witwatersrand Johannesburg View all articles by this author Aung Myint Prince Mshiyeni Memorial Hospital View all articles by this author Portia C. Mutevedzi Emory University Global Health Institute View all articles by this author Diane Morof Centers for Disease Control and Prevention Division of Global HIV & Tuberculosis View all articles by this author Marelize van Wyk-Heath Centers for Disease Control and Prevention Division of Global HIV & Tuberculosis View all articles by this author Mireille Cheyip Centers for Disease Control and Prevention Division of Global HIV & Tuberculosis View all articles by this author Helen Malherbe North-West University Faculty of Health Sciences View all articles by this author Shobna Sawry University of the Witwatersrand Johannesburg View all articles by this author Andrew Boulle University of Cape Town School of Public Health View all articles by this author Dhayendre Moodley 0000-0003-1849-9631 University of KwaZulu-Natal College of Health Sciences View all articles by this author Emma Kalk 0000-0001-7706-6866 North-West University Faculty of Health Sciences View all articles by this author Lee Fairlie University of the Witwatersrand Johannesburg View all articles by this author Metrics & Citations Metrics Article Usage 204 views 170 downloads .FvxKWukQNSOunydq8rnd { width: 100px; } Citations Download citation Ushma Mehta, Diane Lavies, Thokozile Malaba, et al. The Ubomi Buhle Pregnancy Exposure Registry: A Prospective Cohort Assessing the Safety of Clinical and Medicine Exposures in Pregnancy in South Africa. Authorea . 08 December 2025. DOI: https://doi.org/10.22541/au.176518106.64624818/v1 If you have the appropriate software installed, you can download article citation data to the citation manager of your choice. Simply select your manager software from the list below and click Download. For more information or tips please see 'Downloading to a citation manager' in the Help menu . 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