Vaginal Progesterone to Prevent Preterm Delivery in Women With Preterm Labor (4P)

This study has been terminated.
Sponsor:
Collaborators:
Centre Hospitalier Universitaire Vaudois
University Hospital Inselspital, Berne
Basel Women’s University Hospital
University of Zurich
Kantonsspital Chur
Cantonal Hospital of St. Gallen
Luzerner Kantonsspital
Kantonsspital Winterthur KSW
Besins Laboratory, Belgium
Hospital Bernardino Rivadavia Buenos Aires
Hospital Carlos G. Durand Buenos Aires
CEMIC Buenos Aires
Hospital Donación Francisco Santojanni Buenos Aires
Hospital Dr. Cosme Argerich Buenos Aires
Hospital Dr. T. Alvarez Buenos Aires
Hospital Italiano de Buenos Aires
Hospital J. M. Penna Buenos Aires
Hospital Materno Infantil Ramón Sardá Buenos Aires
Hospital Interzonal Alberto Antranik Eurnekian, provincia Buenos Aires
Hospital Municipal Materno Infantil Comodoro Hugo Cesar Meisner, provincia Buenos Aires
Hospital Comunal de Tigre, provincia Buenos Aires
Hospital Dr. Arturo Oñativia, provincia Buenos Aires
Hospital Dr. Carlos Bocalandro, provincia Buenos Aires
Hospital Héroes de Malvinas, provincia Buenos Aires
Hospital Magdalena V. de Martínez, provincia Buenos Aires
Hospital Mariano y Luciano de la Vega, provincia Buenos Aires
Hospital Municipal Ostaciana B. de Lavignolle, provincia Buenos Aires
Hospital Materno Infantil de San Isidro, provincia Buenos Aires
Hospital Virgen del Carmen, provincia Buenos Aires
Hospital J. B. Iturraspe, Santa Fe
Hospital Maternidad Nuestra Señora De Las Mercedes, Tucumán
Hospital Materno Infantil San Roque, Entre Ríos
Hospital Villa Dolores, Córdoba
Information provided by (Responsible Party):
begoña Martinez de Tejada, University Hospital, Geneva
ClinicalTrials.gov Identifier:
NCT00536003
First received: September 24, 2007
Last updated: June 5, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention Phase
Preterm Delivery
Morbidity
Perinatal Mortality
Drug: progesterone
Drug: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Prevention of Preterm Delivery With Vaginal Progesterone in Women With Preterm Labor

Resource links provided by NLM:


Further study details as provided by University Hospital, Geneva:

Primary Outcome Measures:
  • The principal aim is to demonstrate that progesterone reduces preterm birth before 37 weeks of gestation [ Time Frame: end of pregnancy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 [ Time Frame: end of pregnancy and 28 days after delivery ] [ Designated as safety issue: Yes ]

Enrollment: 384
Study Start Date: July 2006
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 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).
Other Name: Utrogestan
Placebo Comparator: 2 Drug: placebo
vaginal capsules containing placebo, once a day, until 36 6/7 weeks of gestation or until preterm delivery (whichever occurs first).

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00536003

Locations
Argentina
Hospital Interzonal Alberto Antranik Eurnekian
Buenos Aires, Alem 349, Ezeiza, Provincia de Buenos Aires, Argentina
Hospital Carlos G. Durand
Buenos Aires, Av. Diaz Velez 5044, Cuidad Autónoma de Buenos Aires, Argentina
Instituto Universitario CEMIC
Buenos Aires, Av. E. Galván 4102, Ciudad Autónoma de Buenos Aires, Argentina
Hospital Bernardino Rivadavia
Buenos Aires, Av. Las Heras 2670, Cuidad Autónoma de Buenos Aires, 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 Villa Dolores
Buenos Aires, Belgrano 1500, Villa Dolores, Provincia de Códoba, Argentina
Hospital J. B. Iturraspe
Buenos Aires, Bvd. Pellegrini 3551, Provincia de Santa Fe, Argentina
Hospital Comunal de Tigre
Buenos Aires, Casareto 118, Tigre, Provincia de Buenos Aires, Argentina
Hospital Materno Infantil de San Isidro
Buenos Aires, Diego Palma 505, San Isidro, Provincia de Buenos Aires, Argentina
Hospital Virgen del Carmen
Buenos Aires, Dr. Félix Pagola 1502, Zárate, Provincia de Buenos Aires, Argentina
Hospital Dr. T. Alvarez
Buenos Aires, Dr. Juan Felipe Aranguren 2701, Cuidad Autónoma de B.A., Argentina
Hospital Materno Infantil Ramón Sardá
Buenos Aires, Esteban De Luca 2151, Ciudad Autónoma de Buenos Aires, Argentina
Hospital Municipal Materno Infantil Comodoro Meisner
Buenos Aires, Iparaguirre Nº 239, Pte. Derqui, Provincia de Buenos Aires, Argentina
Hospital Italiano de Buenos Aires
Buenos Aires, Juan D. Perón 4190, Ciudad Autónoma de Buenos Aires, Argentina
Hospital Materno Infantil San Roque
Buenos Aires, La Paz 435, Provincia de Entre Ríos, Argentina
Hospital Municipal Ostaciana B. de Lavignolle
Buenos Aires, Monte 848, Morón, Provincia de Buenos Aires, Argentina
Hospital J. M. Penna
Buenos Aires, Pedro Chutro 3380, Cuidad Autónoma de Buenos Aires, Argentina
Hospital Donación Francisco Santojanni
Buenos Aires, Pilar 950, Ciudad Autónoma de Buenos Aires, Argentina
Hospital Dr. Cosme Argerich
Buenos Aires, Py y Margall 750, Cuidad Autónoma de Buenos Aires, Argentina
Hospital Dr. Arturo Oñativia
Buenos Aires, Ramón Carillo 1339, Rafael Calzada, Provincia de Buenos Aires, Argentina
Hospital Héroes de Malvinas
Buenos Aires, Ricardo Balbín 1910, Merlo, Provincia de Buenos Aires, Argentina
Hospital Magdalena V. de Martínez
Buenos Aires, Rura 9 Constituyentes 395, Gral, Pacheco, Provincia de B.A., Argentina
Hospital Dr. Carlos Bocalandro
Buenos Aires, Ruta 8Km. 20,5 n°9100, Loma Hermosa, Provincia de Buenos Aires, Argentina
Switzerland
Universitäts-Frauenklinik Kantonespital Basel
Basel, Switzerland, 4031
Universitätsfrauenklinik Bern
Bern, Switzerland, 3010
Kantonales Frauenspital Chur
Chur, Switzerland, 7000
Maternity of the University Hospital of Geneva
Geneva, Switzerland, 1211
Centre Hospitalier Universitaire Vaudois
Lausanne, Switzerland, 1011
Frauenklinik Kantonspital Luzern
Luzern, Switzerland
Frauenklinik Kantonspital St Gallen
St Gallen, Switzerland, 9007
Frauenklinik Kantonspital Winterthur
Winterthur, Switzerland, 8401
University Hospital Zürich
Zurich, Switzerland, 8091
Sponsors and Collaborators
begoña Martinez de Tejada
Centre Hospitalier Universitaire Vaudois
University Hospital Inselspital, Berne
Basel Women’s University Hospital
University of Zurich
Kantonsspital Chur
Cantonal Hospital of St. Gallen
Luzerner Kantonsspital
Kantonsspital Winterthur KSW
Besins Laboratory, Belgium
Hospital Bernardino Rivadavia Buenos Aires
Hospital Carlos G. Durand Buenos Aires
CEMIC Buenos Aires
Hospital Donación Francisco Santojanni Buenos Aires
Hospital Dr. Cosme Argerich Buenos Aires
Hospital Dr. T. Alvarez Buenos Aires
Hospital Italiano de Buenos Aires
Hospital J. M. Penna Buenos Aires
Hospital Materno Infantil Ramón Sardá Buenos Aires
Hospital Interzonal Alberto Antranik Eurnekian, provincia Buenos Aires
Hospital Municipal Materno Infantil Comodoro Hugo Cesar Meisner, provincia Buenos Aires
Hospital Comunal de Tigre, provincia Buenos Aires
Hospital Dr. Arturo Oñativia, provincia Buenos Aires
Hospital Dr. Carlos Bocalandro, provincia Buenos Aires
Hospital Héroes de Malvinas, provincia Buenos Aires
Hospital Magdalena V. de Martínez, provincia Buenos Aires
Hospital Mariano y Luciano de la Vega, provincia Buenos Aires
Hospital Municipal Ostaciana B. de Lavignolle, provincia Buenos Aires
Hospital Materno Infantil de San Isidro, provincia Buenos Aires
Hospital Virgen del Carmen, provincia Buenos Aires
Hospital J. B. Iturraspe, Santa Fe
Hospital Maternidad Nuestra Señora De Las Mercedes, Tucumán
Hospital Materno Infantil San Roque, Entre Ríos
Hospital Villa Dolores, Córdoba
Investigators
Principal Investigator: Begona Martinez de Tejada, MD, PhD University Hospital, Geneva
  More Information

No publications provided

Responsible Party: begoña Martinez de Tejada, MD, PhD, University Hospital, Geneva
ClinicalTrials.gov Identifier: NCT00536003     History of Changes
Other Study ID Numbers: CER: 04-196, matped 04-001
Study First Received: September 24, 2007
Last Updated: June 5, 2012
Health Authority: Switzerland: Swissmedic
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica

Keywords provided by University Hospital, Geneva:
preterm delivery
preterm labor
perinatal morbidity
perinatal mortality

Additional relevant MeSH terms:
Obstetric Labor, Premature
Premature Birth
Obstetric Labor Complications
Pregnancy Complications
Progesterone
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 16, 2014