Document Detail


Prevention of preterm birth in triplets using 17 alpha-hydroxyprogesterone caproate: a randomized controlled trial.
MedLine Citation:
PMID:  19155896     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
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.
Authors:
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:
Type:  Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, N.I.H., Extramural    
Journal Detail:
Title:  Obstetrics and gynecology     Volume:  113     ISSN:  0029-7844     ISO Abbreviation:  Obstet Gynecol     Publication Date:  2009 Feb 
Date Detail:
Created Date:  2009-01-21     Completed Date:  2009-02-23     Revised Date:  2014-09-14    
Medline Journal Info:
Nlm Unique ID:  0401101     Medline TA:  Obstet Gynecol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  285-92     Citation Subset:  AIM; IM    
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT00099164
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MeSH Terms
Descriptor/Qualifier:
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:
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/HD/NICHD NIH HHS; R24 HD050924-07/HD/NICHD NIH HHS; U10 HD021410/HD/NICHD NIH HHS; U10 HD021410-24/HD/NICHD NIH HHS
Chemical
Reg. No./Substance:
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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