Risk Factors for Adverse Birth Outcomes in the PROMISE 1077BF/1077FF Trial
Year: 2019
Type: article
Abstract: BACKGROUND: In the multicountry PROMISE 1077BF/1077FF trial, the risk of low birth weight (LBW; <2500 g) and preterm delivery (PTD; <37 weeks) was significantly higher among women initiating a protease inhibitor-based antiretroviral treatment (ART) regimen than those receiving ZDV alone. Among those assigned to a protease inhibitor regimen, tenofovir/emtricitabine was associated with the more severe outcomes of very LBW (<1500 g) and very PTD (<34 weeks) compared with zidovudine/lamivudine. METHODS: We used multivariate logistic regression to further explore these treatment findings, taking into account demographic baseline clinical and postentry obstetrical factors. We evaluated individual adverse outcomes and composites that included stillbirth and early loss/spontaneous abortion. RESULTS: Among 3333 women delivering at least 1 live infant, median maternal age at enrollment was 26 years; 661 (20%) were primiparous, and 110 (3.3%) reported at least 1 previous PTD. Seventeen percent of newborns were LBW, 1% were very LBW, 17% had PTD, and 3% had very PTD. Treatment allocation remained strongly associated with multiple adverse outcomes after controlling for other risk factors with both ART regimens exhibiting increased risk relative to ZDV alone. Other risk factors remaining significant in at least one of the multivariate models included the following: country, gestational age at entry, maternal age, maternal body mass index, previous PTD, history of alcohol use, baseline HIV viral titer, multiple gestation, and several obstetric risk factors. CONCLUSIONS: ART effects on adverse pregnancy outcomes reported in the randomized PROMISE trial remained strongly significant even after controlling for demographic, baseline clinical, and obstetrical risk factors, which were also associated with these outcomes.
Institutions: MUJHU Research Collaboration, Harvard University, University of North Carolina at Chapel Hill, National Institutes of Health, Eunice Kennedy Shriver National Institute of Child Health and Human Development, University of the Witwatersrand, University of Zimbabwe, University of Cape Town, Anova Health Institute, University of KwaZulu-Natal, Johns Hopkins University, Stellenbosch University, Johns Hopkins Medicine
Language: English
Subfield: Infectious Diseases
Field: Medicine
Domain: Health Sciences
Open Access status: green
Awards: Developing appropriate risk reduction interventions for pre-teens, UZ-UCSF Clinical Trials Unit, BIOMEDICAL INFORMATION DEVELOPMENT IN SUB-SAHARAN AFRICA, SDMC - IMPAACT Leadership Group, UZ-UCSF CTU, International Maternal, Adolescent and Pediatric Therapeutics Clinical Trials Network, Malawi HIV Implementation Research Scientist Training Program (MHIRST), A mentoring program for HIV prevention in pregnancy and postpartum, The Johns Hopkins University-Blantyre Clinical Trials Unit, The University of North Carolina Center for AIDS Research, University of North Carolina Global HIV Prevention and Treatment Clinical Trials Unit, The Johns Hopkins University - Uganda Clinical Trials Unit, KwaZulu-Natal Clinical Trials Unit, PHRU-Setshaba Clinical Trials Unit, IMPAACT Leadership Group
OpenAlex ID: W2943803911