Cited by 1,555Preterm Birth and ChorioamnionitisInfant Development and Preterm CareNeonatal Respiratory Health Research

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Prevention of recurrent preterm delivery by 17 alpha–hydroxyprogesterone caproate

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Meis, Paul J., Klebanoff, Mark, Thom, Elizabeth, Dombrowski, Mitchell P., Sibai, Baha, Moawad, Atef H., Spong, Catherine Y., Hauth, John C., Miodovnik, Menachem, Varner, Michael W., Leveno, Kenneth J., Caritis, Steve N., Iams, Jay D., Wapner, Ronald J., Conway, Deborah, O'Sullivan, Mary J., Carpenter, Marshall, Mercer, Brian, Ramin, Susan M., Thorp, John M., Peaceman, Alan M., Gabbe, Steven·2003·New England Journal of Medicine

DOI 10.1056/nejmoa035140

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Abstract

BACKGROUND: Women who have had a spontaneous preterm delivery are at greatly increased risk for preterm delivery in subsequent pregnancies. The results of several small trials have suggested that 17 alpha-hydroxyprogesterone caproate (17P) may reduce the risk of preterm delivery. METHODS: We conducted a double-blind, placebo-controlled trial involving pregnant women with a documented history of spontaneous preterm delivery. Women were enrolled at 19 clinical centers at 16 to 20 weeks of gestation and randomly assigned by a central data center, in a 2:1 ratio, to receive either weekly injections of 250 mg of 17P or weekly injections of an inert oil placebo; injections were continued until delivery or to 36 weeks of gestation. The primary outcome was preterm delivery before 37 weeks of gestation. Analysis was performed according to the intention-to-treat principle. RESULTS: Base-line characteristics of the 310 women in the progesterone group and the 153 women in the placebo group were similar. Treatment with 17P significantly reduced the risk of delivery at less than 37 weeks of gestation (incidence, 36.3 percent in the progesterone group vs. 54.9 percent in the placebo group; relative risk, 0.66 [95 percent confidence interval, 0.54 to 0.81]), delivery at less than 35 weeks of gestation (incidence, 20.6 percent vs. 30.7 percent; relative risk, 0.67 [95 percent confidence interval, 0.48 to 0.93]), and delivery at less than 32 weeks of gestation (11.4 percent vs. 19.6 percent; relative risk, 0.58 [95 percent confidence interval, 0.37 to 0.91]). Infants of women treated with 17P had significantly lower rates of necrotizing enterocolitis, intraventricular hemorrhage, and need for supplemental oxygen. CONCLUSIONS: Weekly injections of 17P resulted in a substantial reduction in the rate of recurrent preterm delivery among women who were at particularly high risk for preterm delivery and reduced the likelihood of several complications in their infants.

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Authors: Meis, P. J., Klebanoff, M., Thom, E., Dombrowski, M. P., Sibai, B., Moawad, A. H., Spong, C. Y., Hauth, J. C., Miodovnik, M., Varner, M. W., Leveno, K. J., Caritis, S. N., Iams, J. D., Wapner, R. J., Conway, D., O'Sullivan, M. J., Carpenter, M., Mercer, B., Ramin, S. M., Thorp, J. M., Peaceman, A. M., & Gabbe, S.
Affiliations: Wayne State University (US)
National Institutes of Health (US)
University of Pittsburgh (US)
Thomas Jefferson University (US)
From Wake Forest University, Winston-Salem, N.C. (P.J.M.); the National Institute of Child Health and Human Development, Bethesda, Md. (M.K., C.Y.S.); the Biostatistics Center, George Washington University, Rockville, Md. (E.T.); Wayne State University, Detroit (M.P.D.); the University of Tennessee, Memphis (B.S.); the University of Chicago, Chicago (A.H.M.); the University of Alabama, Birmingham (J.C.H.); the University of Cincinnati, Cincinnati,...
University of North Carolina at Chapel Hill (US)
Northwestern University (US)
ORCID: Thom, Elizabeth
Sibai, Baha
Varner, Michael W.
Caritis, Steve N.
Iams, Jay D.
Wapner, Ronald J.
Conway, Deborah
Thorp, John M.
Peaceman, Alan M.
Gabbe, Steven
Venue: New England Journal of Medicine
Publisher: Massachusetts Medical Society
Published: 2003-06-12
Volume: 348
Issue: 24
Pages: 2379-2385
ISSN: 0028-4793 (ISSN-L)
1533-4406
DOI: 10.1056/nejmoa035140
OpenAlex: W2065614074
Cited by: 1,555
References: 27
Citations by year: 2026: 19 · 2025: 29 · 2024: 38 · 2023: 46 · 2022: 50 · 2021: 53 · 2020: 72 · 2019: 56 · 2018: 66 · 2017: 141 · 2016: 94 · 2015: 73 · 2014: 71 · 2013: 85 · 2012: 101
FWCI: 38.77
Type: journal article
Language: en
Open access: bronze
doi.org
Locations: New England Journal of Medicine (publishedVersion)
PubMed (publishedVersion)
Funders: National Center for Research Resources (M01RR000080)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (HD40512, HD27905, HD27917, U10HD027861, HD-27915, HD34116, HD34136, (HD40500, HD34210, HD-21414, HD 40544, HD-27860, HD40560, HD27861, U10HD027917, U10HD027905, U10HD027860, HD 34208, HD 36801, HD34122, U10HD034210, HD27869, [HD21410, U10HD034122, U10HD034136)
Topics: Health Sciences › Medicine › Obstetrics and Gynecology › Preterm Birth and Chorioamnionitis
Health Sciences › Medicine › Pediatrics, Perinatology and Child Health › Infant Development and Preterm Care
Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Neonatal Respiratory Health Research
Keywords: 17-hydroxyprogesterone caproate, preterm birth prevention, progesterone supplementation, neonatal complications, necrotizing enterocolitis, intraventricular hemorrhage, supplemental oxygen
MeSH terms: 17 alpha-Hydroxyprogesterone Caproate, Adult, Birth Weight, Cerebral Hemorrhage, Double-Blind Method, Female, Humans, Hydroxyprogesterones, Infant, Newborn, Infant, Premature, Obstetric Labor, Premature, Oxygen Inhalation Therapy, Pregnancy, Pregnancy Outcome, Risk, Survival Analysis, Enterocolitis, Necrotizing, Progesterone Congeners

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Prevention of recurrent preterm delivery by 17 alpha–hydroxyprogesterone caproate

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