Birth outcomes following antiretroviral exposure during pregnancy : initial results from a pregnancy exposure registry in South Africa

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dc.contributor.authorMehta, Ushma C.en_ZA
dc.contributor.authorVan Schalkwyk, Carien_ZA
dc.contributor.authorNaidoo, Prineethaen_ZA
dc.contributor.authorRamkissoon, Arthien_ZA
dc.contributor.authorMhlongo, Ottyen_ZA
dc.contributor.authorMaharaj, Niren R.en_ZA
dc.contributor.authorNaidoo, Nireeen_ZA
dc.contributor.authorFieggen, Karenen_ZA
dc.contributor.authorUrban, Michael F.en_ZA
dc.contributor.authorKrog, Shaunen_ZA
dc.contributor.authorWelte, Alexen_ZA
dc.contributor.authorDheda, Mukeshen_ZA
dc.contributor.authorPillay, Yoganen_ZA
dc.contributor.authorMoran, Neil F.en_ZA
dc.date.accessioned2020-04-08T07:05:18Z
dc.date.available2020-04-08T07:05:18Z
dc.date.issued2019
dc.descriptionCITATION: Mehta, U. C. et al. 2019. Birth outcomes following antiretroviral exposure during pregnancy : initial results from a pregnancy exposure registry in South Africa. Southern African Journal of HIV Medicine, 20(1):a971, doi:10.4102/sajhivmed.v20i1.971.
dc.descriptionThe original publication is available at https://sajhivmed.org.za
dc.description.abstractBackground: In 2013, a pregnancy exposure registry and birth defects surveillance (PER/BDS) system was initiated in eThekwini District, KwaZulu-Natal (KZN), to assess the impact of antiretroviral treatment (ART) on birth outcomes. Objectives: At the end of the first year, we assessed the risk of major congenital malformations (CM) and other adverse birth outcomes (ABOs) detected at birth, in children born to women exposed to ART during pregnancy. Method: Data were collected from women who delivered at Prince Mshiyeni Memorial Hospital, Durban, from 07 October 2013 to 06 October 2014, using medicine exposure histories and birth outcomes from maternal interviews, clinical records and neonatal surface examination. Singleton births exposed to only one ART regimen were included in bivariable analysis for CM risk and multivariate risk analysis for ABO risk. Results: Data were collected from 10 417 women with 10 517 birth outcomes (4013 [38.5%] HIV-infected). Congenital malformations rates in births exposed to Efavirenz during the first trimester (T1) (RR 0.87 [95% CI 0.12–6.4; p = 0.895]) were similar to births not exposed to ART during T1. However, T1 exposure to Nevirapine was associated with the increased risk of CM (RR 9.28 [95% CI 2.3–37.9; p = 0.002]) when compared to the same group. Other ABOs were more frequent in the combination of HIV/ART-exposed births compared to HIV-unexposed births (29.9% vs. 26.0%, adjusted RR 1.23 [1.14–1.31; p < 0.001]). Conclusion: No association between T1 use of EFV-based ART regimens and CM was observed. Associations between T1 NVP-based ART regimen and CM need further investigation. HIV- and ART-exposed infants had more ABOs compared to HIV-unexposed infants.en_ZA
dc.description.versionPublisher's version
dc.format.extent12 pages
dc.identifier.citationMehta, U. C. et al. 2019. Birth outcomes following antiretroviral exposure during pregnancy : initial results from a pregnancy exposure registry in South Africa. Southern African Journal of HIV Medicine, 20(1):a971, doi:10.4102/sajhivmed.v20i1.971.
dc.identifier.issn2078-6751 (online)
dc.identifier.issn1608-9693 (print)
dc.identifier.otherdoi:10.4102/sajhivmed.v20i1.971
dc.identifier.urihttp://hdl.handle.net/10019.1/107668
dc.language.isoen_ZAen_ZA
dc.publisherAOSIS
dc.rights.holderAuthors retain copyright
dc.subjectPharmacovigilanceen_ZA
dc.subjectCongenital malformationsen_ZA
dc.subjectBirth outcomes -- Evaluation -- South Africa -- KwaZulu-Natalen_ZA
dc.subjectAntiretroviral agents -- Effect on pregnant womenen_ZA
dc.subjectPregnancy complicationsen_ZA
dc.subjectPregnant women -- Effect of antiretrovirals onen_ZA
dc.subjectBirth defects -- South Africa -- KwaZulu-Natalen_ZA
dc.titleBirth outcomes following antiretroviral exposure during pregnancy : initial results from a pregnancy exposure registry in South Africaen_ZA
dc.typeArticleen_ZA
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