دورية أكاديمية
Individual and Composite Adverse Pregnancy Outcomes in a Randomized Trial on Isoniazid Preventative Therapy Among Women Living With Human Immunodeficiency Virus.
| العنوان: | Individual and Composite Adverse Pregnancy Outcomes in a Randomized Trial on Isoniazid Preventative Therapy Among Women Living With Human Immunodeficiency Virus. |
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| المؤلفون: | Theron G; Department of Obstetrics and Gynaecology, Stellenbosch University, Cape Town, South Africa., Montepiedra G; Center for Biostatistics in AIDS Research, Harvard TH Chan School of Public Health, Boston, Massachusetts, USA., Aaron L; Center for Biostatistics in AIDS Research, Harvard TH Chan School of Public Health, Boston, Massachusetts, USA., McCarthy K; FHI 360, Durham, North Carolina, USA., Chakhtoura N; Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland, USA., Jean-Philippe P; National Institute of Allergy and Infectious Diseases, Bethesda, Maryland, USA., Zimmer B; Frontier Science Foundation, Amherst, New York, USA., Loftis AJ; University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA., Chipato T; Department of Obstetrics and Gynaecology, University of Zimbabwe College of Health Sciences, Harare, Zimbabwe., Nematadzira T; University of Zimbabwe College of Health Sciences-Clinical Trials Research Centre, Harare, Zimbabwe., Nyati M; Perinatal Human Immunodeficiency Virus (HIV) Research Unit, University of the Witwatersrand, Johannesburg, South Africa., Onyango-Makumbi C; Makerere University-Johns Hopkins University Research Collaboration, Kampala, Uganda., Masheto G; Botswana Harvard AIDS Institute Partnership, Gaborone, Botswana., Ngocho J; Department of Epidemiology and Applied Biostatistics, Kilimanjaro Christian Medical University College, Moshi, Tanzania., Tongprasert F; Department of Obstetrics and Gynecology, Faculty of Medicine, Chiang Mai, Thailand.; Research Institute for Health Sciences, Chiang Mai University, Chiang Mai, Thailand., Patil S; Byramjee Jeejeebhoy Government Medical College, Johns Hopkins University Clinical Research Site, Pune, India., Lespinasse D; Les Centres GHESKIO, Port-au-Prince, Haiti., Weinberg A; Departments of Pediatrics, Medicine and Pathology, University of Colorado Denver Anschutz Medical Center, Aurora, Colorado, USA., Gupta A; Center for Clinical Global Health Education, Division of Infectious Diseases, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA. |
| المصدر: | Clinical infectious diseases : an official publication of the Infectious Diseases Society of America [Clin Infect Dis] 2021 Jun 01; Vol. 72 (11), pp. e784-e790. |
| نوع المنشور: | Journal Article; Randomized Controlled Trial; Research Support, N.I.H., Extramural |
| اللغة: | English |
| بيانات الدورية: | Publisher: Oxford University Press Country of Publication: United States NLM ID: 9203213 Publication Model: Print Cited Medium: Internet ISSN: 1537-6591 (Electronic) Linking ISSN: 10584838 NLM ISO Abbreviation: Clin Infect Dis Subsets: MEDLINE |
| أسماء مطبوعة: | Publication: Jan. 2011- : Oxford : Oxford University Press Original Publication: Chicago, IL : The University of Chicago Press, c1992- |
| مواضيع طبية MeSH: | HIV Infections* , Tuberculosis*, Adolescent ; Child ; Female ; HIV ; Humans ; Infant, Newborn ; Isoniazid ; Pregnancy ; Pregnancy Outcome |
| مستخلص: | Background: International 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. Methods: Pregnant 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. Results: This 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). Conclusions: We 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. (© The Author(s) 2020. Published by Oxford University Press for the Infectious Diseases Society of America.) |
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| معلومات مُعتمدة: | HHSN275201800001C United States HD NICHD NIH HHS; UM1 AI068632 United States AI NIAID NIH HHS; UM1 AI068616 United States AI NIAID NIH HHS; UM1 AI069465 United States AI NIAID NIH HHS; UM1 AI106716 United States AI NIAID NIH HHS; HHSN275201800001I United States HD NICHD NIH HHS |
| فهرسة مساهمة: | Keywords: IPT; adverse pregnancy outcomes |
| المشرفين على المادة: | V83O1VOZ8L (Isoniazid) |
| تواريخ الأحداث: | Date Created: 20200930 Date Completed: 20210705 Latest Revision: 20231107 |
| رمز التحديث: | 20240829 |
| مُعرف محوري في PubMed: | PMC8315231 |
| DOI: | 10.1093/cid/ciaa1482 |
| PMID: | 32997744 |
| قاعدة البيانات: | MEDLINE |
Full Text Finder | تدمد: | 1537-6591 |
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| DOI: | 10.1093/cid/ciaa1482 |