ArticleAIDS (London, England)2014
Pregnancy outcomes and birth defects from an antiretroviral drug safety study of women in South Africa and Zambia.
Article in AIDS (London, England), 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers, 1 of them a synthesis that pooled it.
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Who cites it
10 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Prevalence and associated factors of birth defects among newborns in sub-Saharan African countries: a systematic review and meta-analysis.The Pan African medical journal · 2020Pooled it
- Adverse Pregnancy Outcomes Among Women Who Conceive on Antiretroviral Therapy.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2019Trial
- Developing a surveillance system for HIV pre-exposure prophylaxis (PrEP) use in pregnancy in Malawi.BMC pregnancy and childbirth · 2026Article
- Real-world pharmacovigilance study on neonatal congenital anomalies associated with maternal drug exposure using the FDA Adverse Event Reporting System.Therapeutic advances in drug safety · 2025Article
- Pharmacovigilance in Pregnancy Studies, Exposures and Outcomes Ascertainment, and Findings from Low- and Middle-Income Countries: A Scoping Review.Drug safety · 2024Article
- Epilepsy management in pregnant HIV+ women in sub-Saharan Africa, clinical aspects to consider: a scoping review.BMC medicine · 2020Article
- Birth outcomes following antiretroviral exposure during pregnancy: Initial results from a pregnancy exposure registry in South Africa.Southern African journal of HIV medicine · 2019Article
- Safety and pharmacokinetics of dolutegravir in HIV-positive pregnant women: a systematic review.Journal of virus eradication · 2018Article
- Pregnancy rate and birth outcomes among women receiving antiretroviral therapy in Burkina Faso: a retrospective cohort study.The Pan African medical journal · 2016Article
- DisclosingJournal of the International AIDS Society · 2016Article
Corrections and comments
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Authors and funding
12 authors.
Funding
Abstract
objectiveTo evaluate the safety of combination antiretroviral therapy (ART) in conception and pregnancy in different health systems.
designA pilot ART registry to measure the prevalence of birth defects and adverse pregnancy outcomes in South Africa and Zambia.
methodsHIV-infected pregnant women on ART prior to conception were enrolled until delivery, and their infants were followed until 1 year old.
resultsBetween October 2010 and April 2011, 600 women were enrolled. The median CD4 cell count at study enrollment was lower in South Africa than Zambia (320 vs. 430 cells/μl; P < 0.01). The most common antiretroviral drugs at the time of conception included stavudine, lamivudine, and nevirapine. There were 16 abortions (2.7%), one ectopic pregnancy (0.2%), 12 (2.0%) stillbirths, and 571 (95.2%) live infants. Deliveries were more often preterm (29.7 vs. 18.4%; P = 0.01) and the infants had lower birth weights (2900 vs. 2995 g; P = 0.11) in Zambia compared to South Africa. Thirty-six infants had birth defects: 13 major and 23 minor. There were more major anomalies detected in South Africa and more minor ones in Zambia. No neonatal deaths were attributed to congenital birth defects.
conclusionsAn Africa-specific, multi-site antiretroviral drug safety registry for pregnant women is feasible. Different prevalence for preterm delivery, delivery mode, and birth defect types between women on preconception ART in South Africa and Zambia highlight the potential impact of health systems on pregnancy outcomes. As countries establish ART drug safety registries, documenting health facility limitations may be as essential as the specific ART details.
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