Trial reportClinical infectious diseases : an official publication of the Infectious Diseases Society of America2021
Pregnancy Outcomes of Women Conceiving on Antiretroviral Therapy (ART) Compared to Those Commenced on ART During Pregnancy.
Trial report in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01061151 (Breastfeeding Version of the PROMISE Study), which is not on this map. Cited by 19 papers, 2 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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.
The trial behind it
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.
Breastfeeding Version of the PROMISE Study (Promoting Maternal and Infant Survival Everywhere)
Who cites it
19 citing papers in PubMed, 2 syntheses or guidelines pooled it, 36 citations in OpenAlex.
- Safety and efficacy of major antiviral and immune therapies in pregnancy for maternal viral infections: evidence synthesis of maternal and neonatal outcomes.Frontiers in medicine · 2026Pooled it
- Preconception and periconception interventions to prevent low birth weight, small for gestational age and preterm birth: a systematic review and meta-analysis.BMJ global health · 2022Pooled it
- Maintenance darunavir/ritonavir monotherapy to prevent perinatal HIV transmission, ANRS-MIE 168 MONOGEST study.The Journal of antimicrobial chemotherapy · 2023Trial
- Trial
- IMPAACT 2041: Designing the Study of Glecaprevir/Pibrentasvir Treatment During Pregnancy.Open forum infectious diseases · 2026Article
- 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
- Risk assessment of drug-associated miscarriage using XGBoost and SHAP explainability: a real-world pharmacovigilance analysis based on the FAERS database.Frontiers in pharmacology · 2026Article
- Abortion and its association with antiretroviral therapy among young women living with HIV in northern Uganda: a cross-sectional study.AIDS research and therapy · 2025Article
- An Update on the Clinical Management of HIV and Tuberculosis Co-Infection in Pregnancy: TB Preventative Therapy, Long-Acting ARVs, and Bedaquiline-Based Regimens.Current HIV/AIDS reports · 2025Review
- Association between Maternal HIV and Adverse Birth Outcomes in the Era of Universal Antiretroviral Therapy in Malawi.Journal of acquired immune deficiency syndromes (1999) · 2025Article
- Diminished placental Factor XIIIA1 expression associates with pre-conception antiretroviral treatment and preterm birth in pregnant people living with HIV.bioRxiv : the preprint server for biology · 2024Article
- Three-year outcomes for women newly initiated on lifelong antiretroviral therapy during pregnancy - Malawi option B.AIDS research and therapy · 2023Article
- Antiretroviral Therapy and Adverse Pregnancy Outcomes in People Living with HIV.The New England journal of medicine · 2023Review
- Cardiopulmonary resuscitation of infants at birth: predictable or unpredictable?Acute and critical care · 2022Article
- Antiretroviral choice and severe disease predict poorer neuropsychological outcomes in HIV+ children from Africa.Frontiers in pediatrics · 2022Article
- Antiretroviral Therapy, Sexually Transmitted Infections, and Adverse Pregnancy Outcomes in South Africa.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2021Article
- Treatment and pregnancy outcomes of pregnant women exposed to second-line anti-tuberculosis drugs in South Africa.BMC pregnancy and childbirth · 2021Article
- Review
- Adolescent, Pregnant, and HIV-Infected: Risk of Adverse Pregnancy and Perinatal Outcomes in Young Women from Southern Mozambique.Journal of clinical medicine · 2021Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
14 authors at 12 institutions in 4 countries.
Funding
Abstract
backgroundGlobally, the number of infected women of childbearing age living with human immunodeficiency virus (HIV) and conceiving on antiretroviral therapy (ART) is increasing. Evidence of ART safety at conception and during pregnancy and adverse pregnancy outcomes remains conflicting. The Promoting Maternal and Infant Survival Everywhere (PROMISE) 1077 breastfeeding (BF) and formula feeding (FF) international multisite trials provide an opportunity to examine the impact of ART at conception on pregnancy outcomes with subsequent pregnancies.
methodsThe PROMISE 1077BF/1077FF trials were designed to address key questions in the management of HIV-infected women who did not meet clinical guidelines for ART treatment during the time of the trials. After the period of risk of mother-to-child transmission was over, women were randomized to either continue or discontinue ART. We compared subsequent pregnancy outcomes of nonbreastfeeding women randomized to continue ART following delivery, or breastfeeding women randomized to continue ART following breastfeeding cessation who conceived while on ART to women randomized to discontinue ART, who restarted ART after pregnancy was diagnosed.
resultsPregnancy outcomes of 939 subsequent pregnancies of 826 mothers were recorded. The intention-to-treat analyses showed increased incidence of low birth weight (<2500 g) for women who conceived while on ART (relative risk, 2.65 [95% confidence interval {CI}, 1.20-5.81]), and also a higher risk of spontaneous abortion, stillbirth, or neonatal death (hazard ratio, 1.40 [95% CI, .99-1.98]) compared to women who restarted ART after they were found to be pregnant during trial follow-up.
conclusionsWe found an increased risk for adverse pregnancy outcomes in women conceiving on ART, emphasizing the need for improved obstetric and neonatal care for this group. CLINICAL TRIALS REGISTRATION: NCT01061151.
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What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.