drugset / Trial / NCT00536003

Vaginal Progesterone to Prevent Preterm Delivery in Women With Preterm Labor

NCT00536003

Phase 3 Terminated 384 enrolled begoña Martinez de Tejada Basel Women's University Hospital · collabBesins Laboratory, Belgium · collabCEMIC Buenos Aires · collabCantonal Hospital of St. Gallen · collabCentre Hospitalier Universitaire Vaudois · collabHospital Bernardino Rivadavia Buenos Aires · collabHospital Carlos G. Durand Buenos Aires · collabHospital Comunal de Tigre, provincia Buenos Aires · collabHospital Donación Francisco Santojanni · collabHospital Dr. Arturo Oñativia, provincia Buenos Aires · collabHospital Dr. Carlos Bocalandro, provincia Buenos Aires · collabHospital Dr. T. Alvarez Buenos Aires · collabHospital General de Agudos "Dr. Cosme Argerich" · collabHospital General de Agudos J. M. Penna · collabHospital Héroes de Malvinas, provincia Buenos Aires · collabHospital Interzonal Alberto Antranik Eurnekian, provincia Buenos Aires · collabHospital Italiano de Buenos Aires · collabHospital J. B. Iturraspe, Santa Fe · collabHospital Mariano y Luciano de la Vega, provincia Buenos Aires · collabHospital Maternidad Nuestra Señora De Las Mercedes, Tucumán · collabHospital Materno Infantil Ramón Sardá · collabHospital Materno Infantil San Roque, Entre Ríos · collabHospital Materno Infantil de San Isidro, provincia Buenos Aires · collabHospital Municipal Materno Infantil Comodoro Hugo Cesar Meisner, provincia Buenos Aires · collabHospital Municipal Ostaciana B. de Lavignolle, provincia Buenos Aires · collabHospital Provincial Magdalena V. de Martínez · collabHospital Villa Dolores, Córdoba · collabHospital Virgen del Carmen, provincia Buenos Aires · collabInsel Gruppe AG, University Hospital Bern · collabKantonsspital Graubuenden · collabKantonsspital Winterthur KSW · collabLuzerner Kantonsspital · collabUniversity of Zurich · collab
RandomizedCrossoverQuadruple-blindPrevention

Summary

The administration of vaginal progesterone, in addition to standard tocolysis, will decrease the risk of delivering prematurely and of recurrent preterm labor. We also hypothesize that the reduction in preterm delivery will be associated with a decrease in infant mortality and morbidity.

Timeline

Start
2006-07
Primary completion
2012-12
Completion
2012-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Progesterone Other / unclassified 200 mg Other

Indications

No indication recorded.