Trial reportJournal of perinatal medicine2011
Birth defects among a cohort of infants born to HIV-infected women on antiretroviral medication.
Trial report in Journal of perinatal medicine, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
16 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Zidovudine use in pregnancy and congenital malformations.AIDS (London, England) · 2017Pooled it
- Follow-up and Outcomes of Infants Perinatally-exposed to HIV in a Low-prevalence Setting: The Multicenter Children's HIV Exposure Study 2.Journal of the Pediatric Infectious Diseases Society · 2025Article
- Antiretroviral Options and Treatment Decisions During Pregnancy.Paediatric drugs · 2023Review
- EUROmediCAT signal detection: an evaluation of selected congenital anomaly-medication associations.British journal of clinical pharmacology · 2016Article
- DisclosingJournal of the International AIDS Society · 2016Article
- Brain Imaging and Neurodevelopment in HIV-uninfected Thai Children Born to HIV-infected Mothers.The Pediatric infectious disease journal · 2015Article
- Magnitude of HIV and syphilis seroprevalence among pregnant women in Gondar, Northwest Ethiopia: a cross-sectional study.HIV/AIDS (Auckland, N.Z.) · 2015Article
- Congenital anomalies and in utero antiretroviral exposure in human immunodeficiency virus-exposed uninfected infants.JAMA pediatrics · 2015Article
- First trimester exposure to antiretroviral therapy and risk of birth defects.The Pediatric infectious disease journal · 2014Article
- Safety and effectiveness of antiretroviral therapies for HIV-infected women and their infants and children: protocol for a systematic review and network meta-analysis.Systematic reviews · 2014Article
- Safety of pediatric HIV elimination: the growing population of HIV- and antiretroviral-exposed but uninfected infants.PLoS medicine · 2014Article
- Association between prenatal exposure to antiretroviral therapy and birth defects: an analysis of the French perinatal cohort study (ANRS CO1/CO11).PLoS medicine · 2014Article
- Genetics of congenital heart disease: the glass half empty.Circulation research · 2013Review
- Antiretroviral therapy, pregnancy, and birth defects: a discussion on the updated data.HIV/AIDS (Auckland, N.Z.) · 2013Article
- Complex decisions in managing HIV infection during pregnancy.Current HIV/AIDS reports · 2011Review
- Risk factors of HIV-1 vertical transmission (VT) and the influence of antiretroviral therapy (ART) in pregnancy outcome.Revista do Instituto de Medicina Tropical de Sao PauloArticle
Corrections and comments
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Authors and funding
11 authors.
Funding
Abstract
objectiveTo determine rate of and risk factors for birth defects in infants born to HIV-infected women receiving nucleoside and protease inhibitor antiretroviral (ARV) therapy.
methodsBirth defects were evaluated among infants on the Pediatric AIDS Clinical Trials Group 316 trial that studied addition of peripartum nevirapine to established ARV regimen for prevention of mother-to-child transmission. Maternal therapy was categorized by trimester of earliest exposure. Birth defects were coded using conventions of the Antiretroviral Pregnancy Registry.
resultsBirth defects were detected in 60/1414 (4.2%; 95% CI 3.3-5.4%) infants including 30/636 (4.7%; 95% CI 3.2-6.7%) with first trimester ARV exposure and 30/778 (3.9%; 95% CI 2.6-5.5%) with exposure only after the first trimester (P=0.51). Rates of classes of defects were similar between first trimester compared to later exposure groups except heart defects which occurred in 16 (2.5%; 95% CI 1.4-4.1%) with first trimester ARV exposure and in six (0.8%; 95% CI 0.3-1.7%) infants with later exposure (P=0.02). Exposure to ARV was not associated with specific types of heart defects. Two cases of cardiomyopathy were noted.
conclusionARV use in early pregnancy was not associated with an increased risk of birth defects overall. The possible association of ARV exposure with heart defects requires further surveillance.
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