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J Acquir Immune Defic Syndr. 2019 Aug 15;81(5):521-532. doi: 10.1097/QAI.0000000000002072.

Risk Factors for Adverse Birth Outcomes in the PROMISE 1077BF/1077FF Trial.

Author information

1
Clinical Department, Makerere University-Johns Hopkins University Research Collaboration, Kampala, Uganda.
2
Harvard T.H. Chan School of Public Health, Center for Biostatistics in AIDS Research, Boston, MA.
3
Department of Obstetrics and Gynecology, University of North Carolina School of Medicine, Chapel Hill, NC.
4
National Institutes of Health, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Maternal and Paediatric Infectious Diseases Branch, Bethesda, MD.
5
Department of Obstetrics and Gynaecology, University of North Carolina (UNC) Project Lilongwe, Lilongwe, Malawi.
6
Clinical Research Department, Byramiee Jeeieebhoy Government Medical College, Pune, India.
7
Perinatal HIV Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
8
Department of Obstetrics and Gynecology, University of Zimbabwe, Harare, Zimbabwe.
9
Anova Health Institute, Johannesburg, South Africa.
10
Division of Epidemiology and Biostatistics, School of Public Health and Family Medicine, University of Cape Town, South Africa.
11
Department of Obstetrics and Gynecology, School of Clinical Medicine, Centre for AIDS Research in South Africa, University of KwaZulu Natal, Durban, South Africa.
12
Department of Epidemiology, Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD.
13
Department of Obstetrics and Gynecology, Stellenbosch University, Cape Town, South Africa.
14
Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, MD.

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.

PMID:
31295174
PMCID:
PMC6702964
[Available on 2020-08-15]
DOI:
10.1097/QAI.0000000000002072

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