Vaginal Progesterone to Prevent Preterm Delivery in Women With Preterm Labor

• Status: Terminated
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: begoña Martinez de Tejada
• Collaborators: Basel Women's University Hospital; Basel Women’s University Hospital; Besins Laboratory, Belgium; Cantonal Hospital of St. Gallen; CEMIC Buenos Aires; Centre Hospitalier Universitaire Vaudois; Hospital Bernardino Rivadavia Buenos Aires; Hospital Carlos G. Durand Buenos Aires; Hospital Comunal de Tigre, provincia Buenos Aires; Hospital Donación Francisco Santojanni; Hospital Donación Francisco Santojanni Buenos Aires; Hospital Dr. Arturo Oñativia, provincia Buenos Aires; Hospital Dr. Carlos Bocalandro, provincia Buenos Aires; Hospital Dr. Cosme Argerich Buenos Aires; Hospital Dr. T. Alvarez Buenos Aires; Hospital General de Agudos "Dr. Cosme Argerich"; Hospital Héroes de Malvinas, provincia Buenos Aires; Hospital Interzonal Alberto Antranik Eurnekian, provincia Buenos Aires; Hospital Italiano de Buenos Aires; Hospital J. B. Iturraspe, Santa Fe; Hospital J. M. Penna Buenos Aires; Hospital Mariano y Luciano de la Vega, provincia Buenos Aires; Hospital Maternidad Nuestra Señora De Las Mercedes, Tucumán; Hospital Materno Infantil de San Isidro, provincia Buenos Aires; Hospital Materno Infantil Ramón Sardá; Hospital Materno Infantil Ramón Sardá Buenos Aires; Hospital Materno Infantil San Roque, Entre Ríos; Hospital Municipal Materno Infantil Comodoro Hugo Cesar Meisner, provincia Buenos Aires; Hospital Municipal Ostaciana B. de Lavignolle, provincia Buenos Aires; Hospital Provincial Magdalena V. de Martínez; Hospital Villa Dolores, Córdoba; Hospital Virgen del Carmen, provincia Buenos Aires; Kantonsspital Graubuenden; Kantonsspital Winterthur KSW; Luzerner Kantonsspital; University Hospital Inselspital, Berne; University of Zurich
• Treatments: Progesterone

Criteria

Inclusion Criteria:

• Gestational age between 240/7 et 336/7 weeks of gestation (based on a reliable estimate by ultrasound performed before 22 weeks)

• Singleton pregnancy

• Intact membranes

• Preterm labor defined as:

• 2 or more regular and painful uterine contractions in 10 minutes plus one or plus of the following criteria:

• short cervix detected by vaginal ultrasound scanning (cervical length less than 30 mm until 31 weeks and less than 25 mm from 32 weeks)

• cervical changes detected clinically (cervical length less or equal 10 mm or Bishop score less than 6

• cervical changes during hospitalization (more or equal 5 mm between two clinical or US exams)

• positive fetal fibronectin

• Age ≥ 18 years old

• Signed informed consent

• Possible and accepted follow-up

Exclusion Criteria:

• Multiple gestation

• Cervical cerclage

• Hydramnios (AFI >95th percentile for gestational age or greatest pocket >8 cm)

• Premature rupture of membranes

• Chorioamnionitis (criteria for clinical diagnosis are: elevated WBC, elevated CRP, maternal tachycardia, fetal tachycardia, uterine tenderness and/or amniotic fluid foul odor)

• Cervical dilatation > 3 cm

• Placenta praevia or abruptio placentae

• Intra-uterine growth restriction or non-reassuring fetal status

• Pre-eclampsia or severe hypertension

• Any other maternal or fetal pathology which should indicate medically preterm delivery