Evidence map›Paper›PMID 37768207›Full record

ArticleClinical infectious diseases : an official publication of the Infectious Diseases Society of America2024

Adverse Pregnancy Outcomes Among Women with Human Immunodeficiency Virus Taking Isoniazid Preventive Therapy During the First Trimester.

Amita Gupta, Michael D Hughes, Jorge Leon Cruz, Anchalee Avihingsanon, Noluthando Mwelase, Patrice Severe, Ayotunde Omoz-Oarhe, Gaerolwe Masheto, Laura Moran, Constance A Benson and 2 more

Open access · hybridAbstract read
In one paragraph

Article in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed, 1 pooled it
1.7field-weighted citation impact, top 15% of its field
1 · What the graph read from 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.

2 · The registry

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.

3 · Its place in the literature

Who cites it

12 citing papers in PubMed, 1 synthesis or guideline pooled it, 9 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Article
  4. Article
  5. Review
  6. 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 · 2025
    Article
  7. Improving tuberculosis infection treatment completion among pregnant and postpartum women.Journal of clinical tuberculosis and other mycobacterial diseases · 2025
    Article
  8. Review
  9. Review
  10. Article
  11. Article
  12. TB prevalence among pregnant women with HIV in Rio de Janeiro, Brazil.The international journal of tuberculosis and lung disease : the official journal of the International Union against Tuberculosis and Lung Disease · 2024
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors at 9 institutions in 5 countries.

Amita GuptaDivision of Infectious Diseases, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.ORCID 0000-0001-7036-2718
Michael D HughesCenter for Biostatistics in AIDS Research, Harvard TH Chan School of Public Health, Boston, Massachusetts, USA.
Jorge Leon CruzCenter for Biostatistics in AIDS Research, Harvard TH Chan School of Public Health, Boston, Massachusetts, USA.
Anchalee AvihingsanonHIV-NAT, Thai Red Cross AIDS Research Centre and Center of Excellence in Tuberculosis, Faculty of Medicine Chulalongkorn University, Bangkok, Thailand.
Noluthando MwelaseDepartment of Medicine, University of Witwatersrand, Johannesburg, South Africa.
Patrice SevereClinical Trials Unit, Les Centres GHESKIO, Port-au-Prince, Haiti.
Ayotunde Omoz-OarheBotswana Harvard AIDS Institute Partnership, Clinical Trials Unit, Gaborone, Botswana.
Gaerolwe MashetoBotswana Harvard AIDS Institute Partnership, Clinical Trials Unit, Gaborone, Botswana.
Laura MoranPublic Health and Scientific Research Unit, Social & Scientific Systems, a DLH Company, Silver Spring, Maryland, USA.
Constance A BensonDivision of Infectious Diseases, University of California San Diego School of Medicine, La Jolla, California, USA.
Richard E ChaissonDivision of Infectious Diseases, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
Susan SwindellsDepartment of Internal Medicine, University of Nebraska Medical Center, Omaha, Nebraska, USA.ORCID 0000-0001-5826-6037
Botswana Harvard AIDS Institute Partnership · BWCancer Research And Biostatistics · USJohns Hopkins University · USChulalongkorn University · THGheskio Centers · HTSocial and Scientific Systems (United States) · USUniversity of California San Diego · USUniversity of Nebraska Medical Center · USUniversity of the Witwatersrand · ZA

Funding

Statistical and Data Management Center (SDMC), AIDS Clinical Trials Group (ACTG)UM1AI068634 · NIAID · HARVARD UNIVERSITY D/B/A HARVARD SCHOOL OF PUBLIC HEALTH · PI Marlene Ann Cooper, Michael David Hughes · 2011 to 2026
$246.6M
AIDS Clinical Trials Group NetworkU01AI068636 · NIAID · SOCIAL AND SCIENTIFIC SYSTEMS, INC. · PI KURITZKES, DANIEL R. · 2006 to 2010
$147.1M
Validation, CLIA and Qualification (VQC): Enhancing the RS ratio as a tool for AIDS Clinical Trial Group (ACTG) tuberculosis trialsUM1AI106701 · NIAID · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI Grace M Aldrovandi · 2014 to 2026
$116.8M
Statistical and Data Management Center for the AIDS Clinical Trials GroupU01AI068634 · NIAID · HARVARD SCHOOL OF PUBLIC HEALTH · PI HUGHES, MICHAEL DAVID · 2006 to 2010
$71.9M
UCSD Department of Medicine HIV/AIDS Clinical Trials UnitUM1AI069432 · NIAID · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI TIMOTHY J. WILKIN · 2012 to 2026
$50.4M
The Johns Hopkins Baltimore-Washington-India Clinical Trials Unit (BWI CTU)UM1AI069465 · NIAID · JOHNS HOPKINS UNIVERSITY · PI Charles W. Flexner, Amita Gupta · 2012 to 2026
$34.1M
Wits HIV Research Group CLINICAL TRIAL UNIT (CTU) reapplicationUM1AI069463 · NIAID · WITS HEALTH CONSORTIUM (PTY), LTD · PI REES, HELEN, SANNE, IAN MATTHIAS · 2012 to 2025
$31.8M
Botswana-Harvard T.H. Chan School of Public Health AIDS Initiative Partnership CTU Y18 SupplementUM1AI069456 · NIAID · THE BOTSWANA HARVARD HEALTH PARTNERSHIP · PI SHAHIN LOCKMAN, Joseph Moeketsi Makhema · 2012 to 2026
$29.4M
Units for HIV/AIDS Clinical Trials NetworksU01AI069463 · NIAID · WITS HEALTH CONSORTIUM (PTY), LTD · PI SANNE, IAN MATTHIAS · 2007 to 2011
$24.2M
NIAID NIH HHS U01 AI068634NIAID NIH HHS U01 AI068636NIAID NIH HHS U01 AI069463NIAID NIH HHS UM1 AI068634NIAID NIH HHS UM1 AI069432NIAID NIH HHS UM1 AI069456NIAID NIH HHS UM1 AI069463NIAID NIH HHS UM1 AI069465NIAID NIH HHS UM1 AI106701
6 · The paper itself

Abstract

backgroundIsoniazid preventive therapy (IPT) is recommended for tuberculosis prevention yet data on the safety of first-trimester pregnancy exposure are limited.

methodsPlanned secondary analysis in a TB prevention trial of adverse pregnancy outcomes among participants assigned to 9-month IPT who became pregnant during (IPT-exposed) or after (unexposed) IPT. Regression models compared binary outcomes of a composite adverse outcome (any non-live birth, excluding induced abortion); preterm delivery <37 weeks; and low birth weight <2500 g) among exposure groups. Models were adjusted for latent TB infection, maternal age, CD4 count, and antiretroviral therapy (ART).

resultsIn total, 128 participants had a known pregnancy outcome; 39 IPT-exposed and 89 unexposed. At pregnancy outcome, ART use was lower in IPT-exposed (79%) than unexposed women (98%). Overall, 29 pregnancies ended in a composite adverse outcome (25 spontaneous abortions, 2 stillbirths and 2 ectopic pregnancies), 15 preterm deliveries, and 10 infants with low birth weight. IPT was associated with the composite adverse outcome adjusting for covariates at enrollment (adjusted relative risk [aRR] 1.98; 95% confidence interval [CI] 1.15, 3.41), but the effect was attenuated when adjusted for covariates at pregnancy outcome (aRR 1.47; 95% CI .84, 2.55); IPT was not associated with preterm delivery (relative risk [RR] 0.87; 95% CI .32-2.42) or low birth weight (RR 1.01; 95% CI .29, 3.56).

conclusionsFirst-trimester IPT exposure was associated with nearly two-fold increased risk of fetal demise, mostly spontaneous abortion, though the association was attenuated when adjusted for covariates proximal to pregnancy outcome including ART use. Further study is needed to inform TB prevention guidelines.

Indexed as

Abortion, SpontaneousHIV InfectionsPremature BirthTuberculosisAntitubercular AgentsFemaleHIVHumansInfantInfant, NewbornIsoniazidPregnancyPregnancy OutcomePregnancy Trimester, FirstAntitubercular AgentsIsoniazidadverse pregnancy outcomeHIV infectionisoniazidpregnancyTB preventive therapy

Identifiers

PMID37768207
PMCPMC10954322
OpenAlexW4387114541

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.