Trial reportInfectious diseases in obstetrics and gynecology2013
Pregnancy outcomes in HIV-infected women receiving long-term isoniazid prophylaxis for tuberculosis and antiretroviral therapy.
Trial report in Infectious diseases in obstetrics and gynecology, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00164281 (A Randomized, Placebo-Controlled Study of Limited vs. Continuous Isoniazid Tuberculosis Preventive Therapy in HIV-infected Persons in Botswana), which is not on this map. Cited by 28 papers, 4 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.
A Randomized, Placebo-Controlled Study of Limited vs. Continuous Isoniazid Tuberculosis Preventive Therapy in HIV-infected Persons in Botswana
Who cites it
28 citing papers in PubMed, 4 syntheses or guidelines pooled it, 42 citations in OpenAlex.
- 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
- Safety Evaluation of Antituberculosis Drugs During Pregnancy: A Systematic Review and Meta-Analysis.Frontiers in surgery · 2022Pooled it
- Official American Thoracic Society/Centers for Disease Control and Prevention/Infectious Diseases Society of America Clinical Practice Guidelines: Treatment of Drug-Susceptible Tuberculosis.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2016Guideline
- Outcomes of isoniazid preventive therapy in pregnant women living with HIV: A systematic review and meta-analysis.International journal of immunopathology and pharmacologyPooled it
- Individual and Composite Adverse Pregnancy Outcomes in a Randomized Trial on Isoniazid Preventative Therapy Among Women Living With Human Immunodeficiency Virus.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2021Trial
- Isoniazid Preventive Therapy in HIV-Infected Pregnant and Postpartum Women.The New England journal of medicine · 2019Trial
- 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 Prevention in Pregnant Women Living with HIV: A Review of the Current Management Strategies and Guidance.Infection and drug resistance · 2026Review
- 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
- Tuberculosis Preventive Treatment in High TB-Burden Settings: A State-of-the-Art Review.Drugs · 2025Review
- Adverse pregnancy outcomes and complications of tuberculosis in pregnant women.Frontiers in cellular and infection microbiology · 2025Review
- 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
- Review
- Effect of pregnancy versus postpartum maternal isoniazid preventive therapy on infant growth in HIV-exposed uninfected infants: a post-hoc analysis of the TB APPRISE trial.EClinicalMedicine · 2023Article
- Hepatotoxicity induced by isoniazid in patients with latent tuberculosis infection: a meta-analysis.Gastroenterology and hepatology from bed to bench · 2023Review
- Tuberculosis Infection in Pregnant People: Current Practices and Research Priorities.Pathogens (Basel, Switzerland) · 2022Review
- TB preventive treatment among pregnant women with HIV.The international journal of tuberculosis and lung disease : the official journal of the International Union against Tuberculosis and Lung Disease · 2022Article
- Clinical Pharmacokinetics and Pharmacodynamics of Anti-Tubercular Drugs in Pregnancy.European journal of drug metabolism and pharmacokinetics · 2021Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveWhile 6- to 12-month courses of isoniazid for tuberculosis prevention are considered safe in pregnant women, the effects of longer-term isoniazid prophylaxis or isoniazid in combination with antiretroviral therapy (ART) are not established in human-immunodeficiency-virus-(HIV-) infected women who experience pregnancy during the course of therapy.
designNested study of pregnancy outcomes among HIV-infected women participating in a placebo-controlled, TB-prevention trial using 36 months daily isoniazid. Pregnancy outcomes were collected by interview and record review.
resultsAmong 196 pregnant women, 103 (52.6%) were exposed to isoniazid during pregnancy; all were exposed to antiretroviral drugs. Prior to pregnancy they had received a median of 341 days (range 1-1095) of isoniazid. We observed no isoniazid-associated hepatitis or other severe isoniazid-associated adverse events in the 103 women. Pregnancy outcomes were 132 term live births, 42 premature births, 11 stillbirths, 8 low birth weight, 6 spontaneous abortions, 4 neonatal deaths, and 1 congenital abnormality. In a multivariable model, neither isoniazid nor ART exposure during pregnancy was significantly associated with adverse pregnancy outcome (adjusted odds ratios 0.6, 95% CI: 0.3-1.1 and 1.8, 95% CI 0.9-3.6, resp.).
conclusionsLong-term isoniazid prophylaxis was not associated with adverse pregnancy outcomes, such as preterm delivery, even in the context of ART exposure.
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Registered trials
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