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Failure of 17-hydroxyprogesterone to reduce neonatal morbidity or prolong triplet pregnancy: a double-blind, randomized clinical trial.

Author(s): Combs CA, Garite T, Maurel K, Das A, Porto M; Obstetrix Collaborative Research Network.

Collaborators: Garite T, Combs CA, Maurel K, Abril D, Das AF, Thorp J, Gravett M, Meis P, Elliott J, Ingersoll M, Braescu A, Lyons C, Nageotte M, Preslicka C, Kurtzman J, McCann A, Luthy D, Lopez T, Artis D, Stallings S, Mason L, Miller H, Mercer D, Porto M, Rumney P, Porreco R, Harden L, Bruno M, Lindsay G, DuBois G, Heybourne K, Hall M, Stettler W, Lucero D, Lu G, Brown MJ, Mandsager N, Dawes A, Cope D, Combs A, Mallory K, Rosnes J, Jones K, Tabor B, McAfee A, Root M, Methodist H, Walker M, deVitry Smith S, Roberts D.

Affiliation(s): Obstetrix Medical Group, Sunrise, FL, USA.

Publication date & source: 2010, Am J Obstet Gynecol. , 203(3):248

OBJECTIVE: To test whether 17 alpha-hydroxyprogesterone caproate (17P) will reduce neonatal morbidity by increasing gestational age at delivery in triplet pregnancies. STUDY DESIGN: Double-blind, randomized clinical trial. Mothers carrying trichorionic-triamniotic triplets were randomly assigned (in a 2:1 ratio) to weekly injections of 250 mg of 17P or placebo, starting at 16-22 weeks and continued until 34 weeks. Primary outcome was composite neonatal morbidity. RESULTS: Fifty-six women were randomized to 17P and 25 to placebo. Composite neonatal morbidity occurred with similar frequency in the 17P and placebo groups (38% vs 41%, respectively; P = .71). Mean gestational age at delivery was not affected by 17P (31.9 vs 31.8 weeks; P = .36). There were 13 midtrimester fetal losses with 17P vs none with placebo (P < .02). CONCLUSION: In triplet pregnancy, prophylactic treatment with 17P did not reduce neonatal morbidity or prolong gestation but was associated with increased midtrimester fetal loss.

Erratum in Am J Obstet Gynecol. 2011 Feb;204(2):166.

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