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Background In singleton gestations, 17 alpha-hydroxyprogesterone caproate (17P) has been shown to reduce the rate of recurrent preterm birth. This study was undertaken to evaluate whether 17P would reduce the rate of preterm birth in twin gestations.
Methods We performed a randomized, double-blind, placebo-controlled trial in 14 centers. Healthy women with twin gestations were assigned to weekly intramuscular injections of 250 mg of 17P or matching placebo, starting at 16 to 20 weeks of gestation and ending at 35 weeks. The primary study outcome was delivery or fetal death before 35 weeks of gestation.
Results Six hundred sixty-one women were randomly assigned to treatment. Baseline demographic data were similar in the two study groups. Six women were lost to follow-up; data from 655 were analyzed (325 in the 17P group and 330 in the placebo group). Delivery or fetal death before 35 weeks occurred in 41.5% of pregnancies in the 17P group and 37.3% of those in the placebo group (relative risk, 1.1; 95% confidence interval [CI], 0.9 to 1.3). The rate of the prespecified composite outcome of serious adverse fetal or neonatal events was 20.2% in the 17P group and 18.0% in the placebo group (relative risk, 1.1; 95% CI, 0.9 to 1.5). Side effects of the injections were frequent in both groups, occurring in 65.9% and 64.4% of subjects, respectively (P=0.69), but were generally mild and limited to the injection site.
Conclusions Treatment with 17 alpha-hydroxyprogesterone caproate did not reduce the rate of preterm birth in women with twin gestations. (ClinicalTrials.gov number, NCT00099164
[ClinicalTrials.gov]
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Source Information
From the Departments of Obstetrics and Gynecology, Center for Women's Reproductive Health, University of Alabama at Birmingham, Birmingham (D.J.R.); the University of Pittsburgh, Pittsburgh (S.N.C.); Northwestern University, Chicago (A.M.P.); Drexel University, Philadelphia (A.S.); George Washington University Biostatistics Center, Washington, DC (E.A.T.); the National Institute of Child Health and Human Development, Bethesda, MD (C.Y.S.); the University of Utah, Salt Lake City (M.V.); Columbia University, New York (F.M.); Ohio State University, Columbus (J.D.I.); Case Western Reserve University, Cleveland (B.M.M.); the University of North Carolina, Chapel Hill (J.T.); Wayne State University, Detroit (Y.S.); Brown University, Providence, RI (M.C.); the University of Texas Southwestern Medical Center, Dallas (J.L.); the University of Texas at Houston, Houston (S.R.); Wake Forest University, Winston-Salem, NC (M.H.); and the University of Texas Medical Branch, Galveston (G.A.).
Address reprint requests to Dr. Rouse at the Department of Obstetrics and Gynecology, University of Alabama at Birmingham, 619 19th St. S., OHB 457, Birmingham, AL 35249-7333, or at drouse{at}uab.edu.
Related Letters:
Progesterone and Preterm Birth
O'Brien J. M., Chandiramani M., Tribe R., Shennan A., Nicolaides K. H., Celik E., Fonseca E. B., Rouse D. J., Thom E. A., Spong C. Y., the NICHD Maternal Fetal Medicine Units Network
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N Engl J Med 2007;
357:2306-2307, Nov 29, 2007.
Correspondence
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