Vaginal Progesterone to Prevent Preterm Delivery in Women With Preterm Labor

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.

Conditions

• Preterm Delivery
• Morbidity
• Perinatal Mortality

Interventions

DRUG

progesterone

vaginal capsules containing 200 mg of natural progesterone, once a day, until 36 6/7 weeks of gestation or until preterm delivery (whichever occurs first).

DRUG

placebo

vaginal capsules containing placebo, once a day, until 36 6/7 weeks of gestation or until preterm delivery (whichever occurs first).

Sponsors & Collaborators

• Centre Hospitalier Universitaire Vaudois

  collaborator OTHER

• Insel Gruppe AG, University Hospital Bern

  collaborator OTHER

• Basel Women's University Hospital

  collaborator OTHER

• University of Zurich

  collaborator OTHER

• Kantonsspital Graubuenden

  collaborator OTHER

• Cantonal Hospital of St. Gallen

  collaborator OTHER

• Luzerner Kantonsspital

  collaborator OTHER

• Kantonsspital Winterthur KSW

  collaborator OTHER

• Besins Laboratory, Belgium

  collaborator UNKNOWN

• Hospital Bernardino Rivadavia Buenos Aires

  collaborator UNKNOWN

• Hospital Carlos G. Durand Buenos Aires

  collaborator UNKNOWN

• CEMIC Buenos Aires

  collaborator UNKNOWN

• Hospital Donación Francisco Santojanni

  collaborator OTHER

• Hospital General de Agudos "Dr. Cosme Argerich"

  collaborator OTHER

• Hospital Dr. T. Alvarez Buenos Aires

  collaborator UNKNOWN

• Hospital Italiano de Buenos Aires

  collaborator OTHER

• Hospital J. M. Penna Buenos Aires

  collaborator UNKNOWN

• Hospital Materno Infantil Ramón Sardá

  collaborator NETWORK

• Hospital Interzonal Alberto Antranik Eurnekian, provincia Buenos Aires

  collaborator UNKNOWN

• Hospital Municipal Materno Infantil Comodoro Hugo Cesar Meisner, provincia Buenos Aires

  collaborator UNKNOWN

• Hospital Comunal de Tigre, provincia Buenos Aires

  collaborator UNKNOWN

• Hospital Dr. Arturo Oñativia, provincia Buenos Aires

  collaborator UNKNOWN

• Hospital Dr. Carlos Bocalandro, provincia Buenos Aires

  collaborator UNKNOWN

• Hospital Héroes de Malvinas, provincia Buenos Aires

  collaborator UNKNOWN

• Hospital Provincial Magdalena V. de Martínez

  collaborator OTHER

• Hospital Mariano y Luciano de la Vega, provincia Buenos Aires

  collaborator UNKNOWN

• Hospital Municipal Ostaciana B. de Lavignolle, provincia Buenos Aires

  collaborator UNKNOWN

• Hospital Materno Infantil de San Isidro, provincia Buenos Aires

  collaborator UNKNOWN

• Hospital Virgen del Carmen, provincia Buenos Aires

  collaborator UNKNOWN

• Hospital J. B. Iturraspe, Santa Fe

  collaborator UNKNOWN

• Hospital Maternidad Nuestra Señora De Las Mercedes, Tucumán

  collaborator UNKNOWN

• Hospital Materno Infantil San Roque, Entre Ríos

  collaborator UNKNOWN

• Hospital Villa Dolores, Córdoba

  collaborator UNKNOWN

• begoña Martinez de Tejada

  lead OTHER

Principal Investigators

• Begona Martinez de Tejada, MD, PhD · University Hospital, Geneva

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2006-07-31

Primary Completion

2012-12-31

Completion

2012-12-31

Countries

• Argentina
• Switzerland

Study Locations