Vaginal Progesterone to Prevent Preterm Delivery in Women With Preterm Labor

Morbidity Clinical Trial

— 4P  

Official title:

Prevention of Preterm Delivery With Vaginal Progesterone in Women With Preterm Labor

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00536003
• Other study ID #: CER: 04-196
• Secondary ID: matped 04-001
• Status: Terminated
• Phase: Phase 3
• First received: September 24, 2007
• Last updated: June 5, 2012
• Start date: July 2006
• Est. completion date: December 2012

Study information

• Verified date: June 2012
• Source: University Hospital, Geneva
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: SwissmedicArgentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
• Study type: Interventional

Clinical Trial 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.

Description:

The principal aim is to demonstrate that progesterone reduces preterm birth before 37 weeks of gestation. Secondary aims are to show that progesterone 1) reduces preterm birth before 32 and before 34 weeks of gestation 2) reduces the number and duration of recurring episodes of preterm labor and 3) reduces infant mortality and morbidity.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 384
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Morbidity
• Obstetric Labor, Premature
• Perinatal Mortality
• Premature Birth
• Preterm Delivery

Intervention

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

Locations

Country	Name	City	State
Argentina	Hospital Bernardino Rivadavia	Buenos Aires	Av. Las Heras 2670, Cuidad Autónoma de Buenos Aires
Argentina	Hospital Carlos G. Durand	Buenos Aires	Av. Diaz Velez 5044, Cuidad Autónoma de Buenos Aires
Argentina	Hospital Comunal de Tigre	Buenos Aires	Casareto 118, Tigre, Provincia de Buenos Aires
Argentina	Hospital Donación Francisco Santojanni	Buenos Aires	Pilar 950, Ciudad Autónoma de Buenos Aires
Argentina	Hospital Dr. Arturo Oñativia	Buenos Aires	Ramón Carillo 1339, Rafael Calzada, Provincia de Buenos Aires
Argentina	Hospital Dr. Carlos Bocalandro	Buenos Aires	Ruta 8Km. 20,5 n°9100, Loma Hermosa, Provincia de Buenos Aires
Argentina	Hospital Dr. Cosme Argerich	Buenos Aires	Py y Margall 750, Cuidad Autónoma de Buenos Aires
Argentina	Hospital Dr. T. Alvarez	Buenos Aires	Dr. Juan Felipe Aranguren 2701, Cuidad Autónoma de B.A.
Argentina	Hospital Héroes de Malvinas	Buenos Aires	Ricardo Balbín 1910, Merlo, Provincia de Buenos Aires
Argentina	Hospital Interzonal Alberto Antranik Eurnekian	Buenos Aires	Alem 349, Ezeiza, Provincia de Buenos Aires
Argentina	Hospital Italiano de Buenos Aires	Buenos Aires	Juan D. Perón 4190, Ciudad Autónoma de Buenos Aires
Argentina	Hospital J. B. Iturraspe	Buenos Aires	Bvd. Pellegrini 3551, Provincia de Santa Fe
Argentina	Hospital J. M. Penna	Buenos Aires	Pedro Chutro 3380, Cuidad Autónoma de Buenos Aires
Argentina	Hospital Magdalena V. de Martínez	Buenos Aires	Rura 9 Constituyentes 395, Gral, Pacheco, Provincia de B.A.
Argentina	Hospital Mariano y Luciano de la Vega	Buenos Aires	Av. Libertador 710, Moreno, Provincia de Buenos Aires
Argentina	Hospital Maternidad Nuestra Señora De Las Mercedes	Buenos Aires	Av. Mate de Luna 1555, Provincia de Tucumán
Argentina	Hospital Materno Infantil de San Isidro	Buenos Aires	Diego Palma 505, San Isidro, Provincia de Buenos Aires
Argentina	Hospital Materno Infantil Ramón Sardá	Buenos Aires	Esteban De Luca 2151, Ciudad Autónoma de Buenos Aires
Argentina	Hospital Materno Infantil San Roque	Buenos Aires	La Paz 435, Provincia de Entre Ríos
Argentina	Hospital Municipal Materno Infantil Comodoro Meisner	Buenos Aires	Iparaguirre Nº 239, Pte. Derqui, Provincia de Buenos Aires
Argentina	Hospital Municipal Ostaciana B. de Lavignolle	Buenos Aires	Monte 848, Morón, Provincia de Buenos Aires
Argentina	Hospital Villa Dolores	Buenos Aires	Belgrano 1500, Villa Dolores, Provincia de Códoba
Argentina	Hospital Virgen del Carmen	Buenos Aires	Dr. Félix Pagola 1502, Zárate, Provincia de Buenos Aires
Argentina	Instituto Universitario CEMIC	Buenos Aires	Av. E. Galván 4102, Ciudad Autónoma de Buenos Aires
Switzerland	Universitäts-Frauenklinik Kantonespital Basel	Basel
Switzerland	Universitätsfrauenklinik Bern	Bern
Switzerland	Kantonales Frauenspital Chur	Chur
Switzerland	Maternity of the University Hospital of Geneva	Geneva
Switzerland	Centre Hospitalier Universitaire Vaudois	Lausanne
Switzerland	Frauenklinik Kantonspital Luzern	Luzern
Switzerland	Frauenklinik Kantonspital St Gallen	St Gallen
Switzerland	Frauenklinik Kantonspital Winterthur	Winterthur
Switzerland	University Hospital Zürich	Zurich

Sponsors (34)

Lead Sponsor

Collaborator

begoña Martinez de Tejada

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 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 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 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

Countries where clinical trial is conducted

Argentina,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The principal aim is to demonstrate that progesterone reduces preterm birth before 37 weeks of gestation		end of pregnancy	No
Secondary	Secondary aims are to show that progesterone 1) reduces preterm birth before 32 and before 34 weeks of gestation 2) reduces the number and duration of recurring episodes of preterm labor and 3) reduces perinatal mortality and morbidity, 4)Side effects		end of pregnancy and 28 days after delivery	Yes