Progesterone vaginal gel for the reduction of recurrent preterm birth: primary results from a randomized, double‐blind, placebo‐controlled trial

• DOI: 10.1002/uog.5158
• Publication Date: 2007-09-26T16:52:58Z
• Authors: J. M. O'Brien; C. D. Adair; D. F. Lewis; D. R. Hall; E. A. DEfranco; S. Fusey; P. Soma‐Pillay; K. Porter; H. How; R. Schackis; D. Eller; Y. Trivedi; G. Vanburen; M. Khandelwal; K. Trofatter; D. Vidyadhari; J. Vijayaraghavan; J. Weeks; B. Dattel; E. Newton; C. Chazotte; G. Valenzuela; P. Calda; M. Bsharat; G. W. Creasy
• Keywords: Premature birth

Abstract Objective Preterm birth is the leading cause of perinatal morbidity and mortality worldwide. Treatment preterm labor with tocolysis has not been successful in improving infant outcome. The administration progesterone related compounds proposed as a strategy to prevent birth. objective this trial was determine whether prophylactic vaginal reduces risk women history spontaneous Methods This randomized, double‐blind, placebo‐ controlled, multinational enrolled randomized 659 pregnant Between 18 + 0 22 6 weeks gestation, patients were assigned randomly once‐daily treatment either gel or placebo until delivery, 37 weeks' gestation development rupture membranes. primary outcome at ≤ 32 gestation. analyzed using an intent‐to‐treat strategy. Results Baseline characteristics similar two groups. Progesterone did decrease frequency weeks. There no difference between groups respect mean gestational age other maternal neonatal measures. Adverse events during course for Conclusion Prophylactic reduce recurrent (≤ ) effect high delivery determined by methods than alone (e.g. sonographic cervical length) requires further investigation. Copyright © 2007 ISUOG. Published John Wiley & Sons, Ltd.