Trial reportJournal of acquired immune deficiency syndromes (1999)2019
Risk Factors for Adverse Birth Outcomes in the PROMISE 1077BF/1077FF Trial.
Trial report in Journal of acquired immune deficiency syndromes (1999), 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers.
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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.
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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.
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Who cites it
16 citing papers in PubMed, 29 citations in OpenAlex.
- Congenital Infections as Risk Factor for Adverse Birth Outcomes among HIV-Exposed Neonates in Uganda.Journal of the Pediatric Infectious Diseases Society · 2026Trial
- Inflammation at the maternal-fetal interface: a perspective on interacting risk factors for preterm birth in sub-Saharan African women living with HIV.Frontiers in immunology · 2026Review
- Application of a Physiologically Based Pharmacokinetic Approach to Predict Tenofovir Pharmacokinetics During Pregnancy.The AAPS journal · 2025Article
- Low birth weight and adverse pregnancy outcomes among women living with HIV and HIV-uninfected in Rwanda.PloS one · 2025Article
- Prenatal Diagnosis of Isolated Single Umbilical Artery: Incidence, Risk Factors and Impact on Pregnancy Outcomes.Medicina (Kaunas, Lithuania) · 2023Article
- Antiretroviral Options and Treatment Decisions During Pregnancy.Paediatric drugs · 2023Review
- Article
- Congenital malformations and preeclampsia associated with integrase inhibitor use in pregnancy: A single-center analysis.PloS one · 2023Article
- Comparable Pregnancy Outcomes for HIV-Uninfected and HIV-Infected Women on Antiretroviral Treatment in Kenya.The Journal of infectious diseases · 2022Article
- Surveillance of ARV safety in pregnancy and breastfeeding: towards a new framework.Journal of the International AIDS Society · 2022Article
- Non-linear Relationship of Maternal Age With Risk of Spontaneous Abortion: A Case-Control Study in the China Birth Cohort.Frontiers in public health · 2022Article
- Low Immune Activation in Early Pregnancy Is Associated With Preterm But Not Small-for-gestational-age Delivery in Women Infected With Human Immunodeficiency Virus Initiating Antiretroviral Therapy in Pregnancy: A Prematurity Immunology in HIV-infected Mothers and their Infants Study (PIMS) Case-control Study in Cape Town, South Africa.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2021Article
- CD4/CD8 ratio in pregnant women with HIV and its association with pregnancy outcome: data from a national study in Italy.Infection · 2021Article
- Aetiological testing compared with syndromic management for sexually transmitted infections in HIV-infected pregnant women in South Africa: a non-randomised prospective cohort study.BJOG : an international journal of obstetrics and gynaecology · 2021Article
- Efficacy of Three Antiretroviral Regimens Initiated during Pregnancy: Clinical Experience in Rio de Janeiro.Antimicrobial agents and chemotherapy · 2020Article
- Isoniazid Preventive Therapy and Pregnancy Outcomes in Women Living With Human Immunodeficiency Virus in the Tshepiso Cohort.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2020Observational
Corrections and comments
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Authors and funding
17 authors at 12 institutions in 5 countries.
Funding
Abstract
backgroundIn 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.
methodsWe 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.
resultsAmong 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.
conclusionsART 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.
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