Individual and composite adverse pregnancy outcomes in a randomized trial on isoniazid preventative therapy among women living with human immunodeficiency virus

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dc.contributor.authorTheron, Gerharden_ZA
dc.contributor.authorMontepiedra, Graceen_ZA
dc.contributor.authorAaron, Lisaen_ZA
dc.contributor.authorMcCarthy, Katieen_ZA
dc.contributor.authorChakhtoura, Nahidaen_ZA
dc.contributor.authorJean-Philippe, Patricken_ZA
dc.contributor.authorZimmer, Bonnieen_ZA
dc.contributor.authorLoftis, Amy Jamesen_ZA
dc.contributor.authorChipato, Tsungaien_ZA
dc.contributor.authorNematadzira, Teacleren_ZA
dc.contributor.authorNyati, Mandisaen_ZA
dc.contributor.authorOnyango-Makumbi, Carolyneen_ZA
dc.contributor.authorMasheto, Gaerolween_ZA
dc.contributor.authorNgocho, Jamesen_ZA
dc.contributor.authorTongprasert, Fuangladaen_ZA
dc.contributor.authorPatil, Sandeshen_ZA
dc.contributor.authorLespinasse, Dominiqueen_ZA
dc.contributor.authorWeinberg, Adrianaen_ZA
dc.contributor.authorGupta, Amitaen_ZA
dc.date.accessioned2022-06-06T06:32:15Zen_ZA
dc.date.available2022-06-06T06:32:15Zen_ZA
dc.date.issued2021-06-01en_ZA
dc.descriptionCITATION: Theron, G. et al. 2021. Individual and Composite Adverse Pregnancy Outcomes in a Randomized Trial on Isoniazid Preventative Therapy Among Women Living With Human Immunodeficiency Virus. Clinical infectious diseases, 72(11):e784–e790. doi:10.1093/cid/ciaa1482en_ZA
dc.descriptionThe original publication is available at https://academic.oup.com/cid/en_ZA
dc.description.abstractBackground: International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) P1078, a randomized noninferiority study designed to compare the safety of starting isoniazid preventive therapy (IPT) in women living with human immunodeficiency virus (HIV) either during pregnancy or after delivery, showed that IPT during pregnancy increased the risk of composite adverse pregnancy outcomes, but not individual outcomes. Many known factors are associated with adverse pregnancy outcomes: these factors' associations and effect modifications with IPT and pregnancy outcomes were examined. Methods: Pregnant women living with HIV from 8 countries with tuberculosis incidences >60/100 000 were randomly assigned to initiate 28 weeks of IPT either during pregnancy or at 12 weeks after delivery. Using univariable and multivariable logistic regression and adjusting for factors associated with pregnancy outcomes, composite and individual adverse pregnancy outcome measures were analyzed. Results: This secondary analysis included 925 mother-infant pairs. All mothers were receiving antiretrovirals. The adjusted odds of fetal demise, preterm delivery (PTD), low birth weight (LBW), or a congenital anomaly (composite outcome 1) were 1.63 times higher among women on immediate compared to deferred IPT (95% confidence interval [CI], 1.15-2.31). The odds of fetal demise, PTD, LBW, or neonatal death within 28 days (composite outcome 2) were 1.62 times higher among women on immediate IPT (95% CI, 1.14-2.30). The odds of early neonatal death within 7 days, fetal demise, PTD, or LBW (composite outcome 3) were 1.74 times higher among women on immediate IPT (95% CI, 1.22-2.49). Conclusions: We confirmed higher risks of adverse pregnancy outcomes associated with the initiation of IPT during pregnancy, after adjusting for known risk factors for adverse pregnancy outcomes.en_ZA
dc.description.urihttps://academic.oup.com/cid/article/72/11/e784/5913421?login=trueen_ZA
dc.description.versionPublishers versionen_ZA
dc.format.extent7 pagesen_ZA
dc.identifier.citationTheron, G. et al. 2021. Individual and Composite Adverse Pregnancy Outcomes in a Randomized Trial on Isoniazid Preventative Therapy Among Women Living With Human Immunodeficiency Virus. Clinical infectious diseases, 72(11):e784–e790. doi:10.1093/cid/ciaa1482en_ZA
dc.identifier.issn1537-6591 (online)en_ZA
dc.identifier.issn1058-4838 (print)en_ZA
dc.identifier.otherdoi:10.1093/cid/ciaa1482en_ZA
dc.identifier.urihttp://hdl.handle.net/10019.1/125315en_ZA
dc.language.isoen_ZAen_ZA
dc.publisherOxford University Pressen_ZA
dc.rights.holderAuthors retain copyrighten_ZA
dc.subjectClinical trialsen_ZA
dc.subjectAdverse pregnancy outcomesen_ZA
dc.subjectIsoniaziden_ZA
dc.subjectPreventative therapyen_ZA
dc.subjectHIV-positive womenen_ZA
dc.subjectPregnancy -- Complicationsen_ZA
dc.subjectHIV infections -- Treatmenten_ZA
dc.subjectMaternal health servicesen_ZA
dc.subjectAdverse pregnancy outcomesen_ZA
dc.titleIndividual and composite adverse pregnancy outcomes in a randomized trial on isoniazid preventative therapy among women living with human immunodeficiency virusen_ZA
dc.typeArticleen_ZA
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