| Prevention of preterm birth in triplets using 17 alpha-hydroxyprogesterone caproate: a randomized controlled trial. | |
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MedLine Citation:
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PMID: 19155896 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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OBJECTIVE: To assess whether 17 alpha-hydroxyprogesterone caproate reduces the rate of preterm birth in women carrying triplets. METHODS: We performed this randomized, double-blinded, placebo-controlled trial in 14 centers. Healthy women with triplets were randomly assigned to weekly intramuscular injections of either 250 mg of 17 alpha-hydroxyprogesterone caproate or matching placebo, starting at 16-20 weeks and ending at delivery or 35 weeks of gestation. The primary study outcome was delivery or fetal loss before 35 weeks. RESULTS: One hundred thirty-four women were assigned, 71 to 17 alpha-hydroxyprogesterone caproate and 63 to placebo; none were lost to follow-up. Baseline demographic data were similar in the two groups. The proportion of women experiencing the primary outcome (a composite of delivery or fetal loss before 35 0/7 weeks) was similar in the two treatment groups: 83% of pregnancies in the 17 alpha-hydroxyprogesterone caproate group and 84% in the placebo group, relative risk 1.0, 95% confidence interval 0.9-1.1. The lack of benefit of 17 alpha-hydroxyprogesterone caproate was evident regardless of the conception method or whether a gestational age cutoff for delivery was set at 32 or 28 weeks. CONCLUSION: Treatment with 17 alpha-hydroxyprogesterone caproate did not reduce the rate of preterm birth in women with triplet gestations. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT00099164 LEVEL OF EVIDENCE: I. |
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Authors:
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Steve N Caritis; Dwight J Rouse; Alan M Peaceman; Anthony Sciscione; Valerija Momirova; Catherine Y Spong; Jay D Iams; Ronald J Wapner; Michael Varner; Marshall Carpenter; Julie Lo; John Thorp; Brian M Mercer; Yoram Sorokin; Margaret Harper; Susan Ramin; Garland Anderson; |
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Publication Detail:
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Type: Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, N.I.H., Extramural |
Journal Detail:
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Title: Obstetrics and gynecology Volume: 113 ISSN: 0029-7844 ISO Abbreviation: Obstet Gynecol Publication Date: 2009 Feb |
Date Detail:
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Created Date: 2009-01-21 Completed Date: 2009-02-23 Revised Date: 2011-08-01 |
Medline Journal Info:
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Nlm Unique ID: 0401101 Medline TA: Obstet Gynecol Country: United States |
Other Details:
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Languages: eng Pagination: 285-92 Citation Subset: AIM; IM |
Affiliation:
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Departments of Obstetrics and Gynecology, University of Pittsburgh, Pittsburgh, PA 15213, USA. scaritis@mail.magee.edu |
| Data Bank Information | |
Bank Name/Acc. No.:
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ClinicalTrials.gov/NCT00099164 |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Adult Female Humans Hydroxyprogesterones / administration & dosage* Injections, Intramuscular Pregnancy Premature Birth / prevention & control* Progestins / administration & dosage* Risk Treatment Failure Triplets |
| Grant Support | |
ID/Acronym/Agency:
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HD21410/HD/NICHD NIH HHS; HD27860/HD/NICHD NIH HHS; HD27869/HD/NICHD NIH HHS; HD27915/HD/NICHD NIH HHS; HD27917/HD/NICHD NIH HHS; HD34116/HD/NICHD NIH HHS; HD34136/HD/NICHD NIH HHS; HD34208/HD/NICHD NIH HHS; HD36801/HD/NICHD NIH HHS; HD40485/HD/NICHD NIH HHS; HD40500/HD/NICHD NIH HHS; HD40512/HD/NICHD NIH HHS; HD40544/HD/NICHD NIH HHS; HD40545/HD/NICHD NIH HHS; HD40560/HD/NICHD NIH HHS; HD53097/HD/NICHD NIH HHS; R24 HD050924-07/HD/NICHD NIH HHS; U10 HD021410-24/HD/NICHD NIH HHS |
| Chemical | |
Reg. No./Substance:
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0/Hydroxyprogesterones; 0/Progestins; 630-56-8/17-alpha-hydroxy-progesterone caproate |
| Comments/Corrections | |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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