Ontology highlight
ABSTRACT: 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, NCT00099164Level of evidence
I.
SUBMITTER: Caritis SN
PROVIDER: S-EPMC2790283 | biostudies-literature | 2009 Feb
REPOSITORIES: biostudies-literature
Caritis Steve N SN Rouse Dwight J DJ Peaceman Alan M AM Sciscione Anthony A Momirova Valerija V Spong Catherine Y CY Iams Jay D JD Wapner Ronald J RJ Varner Michael M Carpenter Marshall M Lo Julie J Thorp John J Mercer Brian M BM Sorokin Yoram Y Harper Margaret M Ramin Susan S Anderson Garland G
Obstetrics and gynecology 20090201 2 Pt 1
<h4>Objective</h4>To assess whether 17 alpha-hydroxyprogesterone caproate reduces the rate of preterm birth in women carrying triplets.<h4>Methods</h4>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 ...[more]