From the Departments of Obstetrics and Gynecology, 1University of Pittsburgh, Pittsburgh, Pennsylvania; the 2Center for Women’s Reproductive Health, University of Alabama at Birmingham, Birmingham, Alabama; 3Northwestern University, Chicago, Illinois; 4Drexel University, Philadelphia, Pennsylvania; the 5George Washington University Biostatistics Center, Washington, DC; 6Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland; 7Ohio State University, Columbus, Ohio; 8Columbia University, New York, New York; 9University of Utah, Salt Lake City, Utah; 10Brown University, Providence, Rhode Island; 11University of Texas Southwestern Medical Center, Dallas, Texas; 12University of North Carolina, Chapel Hill, North Carolina; 13Case Western University, Cleveland, Ohio; 14Wayne State University, Detroit, Michigan; 15Wake Forest University, Winston-Salem, North Carolina; 16University of Texas at Houston, Houston, Texas; and 17University of Texas Medical Branch, Galveston, Texas.
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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, NCT00099164LEVEL OF EVIDENCE:I