Trial reportClinical infectious diseases : an official publication of the Infectious Diseases Society of America2021
Individual and Composite Adverse Pregnancy Outcomes in a Randomized Trial on Isoniazid Preventative Therapy Among Women Living With Human Immunodeficiency Virus.
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. Cited by 16 papers, 2 of them syntheses that pooled it.
What it found
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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.
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
16 citing papers in PubMed, 2 syntheses or guidelines pooled it, 16 citations in OpenAlex.
- Safety Evaluation of Antituberculosis Drugs During Pregnancy: A Systematic Review and Meta-Analysis.Frontiers in surgery · 2022Pooled it
- Outcomes of isoniazid preventive therapy in pregnant women living with HIV: A systematic review and meta-analysis.International journal of immunopathology and pharmacologyPooled it
- IMPAACT 2041: Designing the Study of Glecaprevir/Pibrentasvir Treatment During Pregnancy.Open forum infectious diseases · 2026Article
- Tuberculosis Prevention in Pregnant Women Living with HIV: A Review of the Current Management Strategies and Guidance.Infection and drug resistance · 2026Review
- Isoniazid monotherapy for tuberculosis prevention during pregnancy and adverse outcomes in women living with HIV in Uganda: A propensity score-weighted analysis of routine care data.PLOS global public health · 2026Article
- Tuberculosis Preventive Treatment for Pregnant People With HIV in South Africa: A Modeling Analysis of Clinical Benefits and Risks.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2025Article
- Impact of Tuberculosis Preventive Treatment on Adverse Pregnancy Outcomes in women living with HIV in Uganda: A Quasi-experimental study using routine care data.Research square · 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
- Pharmacovigilance in Pregnancy Studies, Exposures and Outcomes Ascertainment, and Findings from Low- and Middle-Income Countries: A Scoping Review.Drug safety · 2024Article
- Adverse Pregnancy Outcomes Among Women with Human Immunodeficiency Virus Taking Isoniazid Preventive Therapy During the First Trimester.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2024Article
- Tuberculosis in pregnancy.Best practice & research. Clinical obstetrics & gynaecology · 2022Review
- Pregnancy-Related Tuberculous Meningitis and Immune Reconstitution Inflammatory Syndrome: A Case Series and Systematic Review.Open forum infectious diseases · 2022Article
- Diagnosis and treatment of tuberculosis in adults with HIV.Medicine · 2022Review
- Interferon Gamma Release Assay and Tuberculin Skin Test Performance in Pregnant Women Living With and Without HIV.Journal of acquired immune deficiency syndromes (1999) · 2022Article
- Stages of pregnancy and HIV affect diagnosis of tuberculosis infection and Mycobacterium tuberculosis (MTB)-induced immune response: Findings from PRACHITi, a cohort study in Pune, India.International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases · 2021Article
- Using a Composite Maternal-Infant Outcome Measure in Tuberculosis-Prevention Studies Among Pregnant Women.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 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
19 authors at 17 institutions in 9 countries.
Funding
Abstract
backgroundInternational 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.
methodsPregnant 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.
resultsThis 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).
conclusionsWe 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.
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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.