Clinical trial NCT00536003: Vaginal Progesterone to Prevent Preterm Delivery in Women With Preterm Labor
Official title: Prevention of Preterm Delivery With Vaginal Progesterone in Women With Preterm Labor
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Preterm Delivery
Morbidity
Perinatal Mortality
Keywords: preterm delivery
preterm labor
perinatal morbidity
perinatal mortality
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
Collaborators: name: Centre Hospitalier Universitaire Vaudois
name: Insel Gruppe AG, University Hospital Bern
name: Basel Women's University Hospital
name: University of Zurich
name: Kantonsspital Graubuenden
name: Cantonal Hospital of St. Gallen
name: Luzerner Kantonsspital
name: Kantonsspital Winterthur KSW
name: Besins Laboratory, Belgium
name: Hospital Bernardino Rivadavia Buenos Aires
name: Hospital Carlos G. Durand Buenos Aires
name: CEMIC Buenos Aires
name: Hospital Donación Francisco Santojanni
name: Hospital General de Agudos "Dr. Cosme Argerich"
name: Hospital Dr. T. Alvarez Buenos Aires
name: Hospital Italiano de Buenos Aires
name: Hospital J. M. Penna Buenos Aires
name: Hospital Materno Infantil Ramón Sardá
name: Hospital Interzonal Alberto Antranik Eurnekian, provincia Buenos Aires
name: Hospital Municipal Materno Infantil Comodoro Hugo Cesar Meisner, provincia Buenos Aires
name: Hospital Comunal de Tigre, provincia Buenos Aires
name: Hospital Dr. Arturo Oñativia, provincia Buenos Aires
name: Hospital Dr. Carlos Bocalandro, provincia Buenos Aires
name: Hospital Héroes de Malvinas, provincia Buenos Aires
name: Hospital Provincial Magdalena V. de Martínez
name: Hospital Mariano y Luciano de la Vega, provincia Buenos Aires
name: Hospital Municipal Ostaciana B. de Lavignolle, provincia Buenos Aires
name: Hospital Materno Infantil de San Isidro, provincia Buenos Aires
name: Hospital Virgen del Carmen, provincia Buenos Aires
name: Hospital J. B. Iturraspe, Santa Fe
name: Hospital Maternidad Nuestra Señora De Las Mercedes, Tucumán
name: Hospital Materno Infantil San Roque, Entre Ríos
name: Hospital Villa Dolores, Córdoba
First posted: 2007-09-27
Enrollment: 384
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief 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.

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 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

Primary outcomes:
measure: The principal aim is to demonstrate that progesterone reduces preterm birth before 37 weeks of gestation
timeFrame: end of pregnancy
Secondary outcomes:
measure: 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
timeFrame: end of pregnancy and 28 days after delivery
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Hospital Interzonal Alberto Antranik Eurnekian
state: Alem 349, Ezeiza, Provincia de Buenos Aires
city: Buenos Aires
country: Argentina
facility: Hospital Carlos G. Durand
state: Av. Diaz Velez 5044, Cuidad Autónoma de Buenos Aires
city: Buenos Aires
country: Argentina
facility: Instituto Universitario CEMIC
state: Av. E. Galván 4102, Ciudad Autónoma de Buenos Aires
city: Buenos Aires
country: Argentina
facility: Hospital Bernardino Rivadavia
state: Av. Las Heras 2670, Cuidad Autónoma de Buenos Aires
city: Buenos Aires
country: Argentina
facility: Hospital Mariano y Luciano de la Vega
state: Av. Libertador 710, Moreno, Provincia de Buenos Aires
city: Buenos Aires
country: Argentina
facility: Hospital Maternidad Nuestra Señora De Las Mercedes
state: Av. Mate de Luna 1555, Provincia de Tucumán
city: Buenos Aires
country: Argentina
facility: Hospital Villa Dolores
state: Belgrano 1500, Villa Dolores, Provincia de Códoba
city: Buenos Aires
country: Argentina
facility: Hospital J. B. Iturraspe
state: Bvd. Pellegrini 3551, Provincia de Santa Fe
city: Buenos Aires
country: Argentina
facility: Hospital Comunal de Tigre
state: Casareto 118, Tigre, Provincia de Buenos Aires
city: Buenos Aires
country: Argentina
facility: Hospital Materno Infantil de San Isidro
state: Diego Palma 505, San Isidro, Provincia de Buenos Aires
city: Buenos Aires
country: Argentina
facility: Hospital Virgen del Carmen
state: Dr. Félix Pagola 1502, Zárate, Provincia de Buenos Aires
city: Buenos Aires
country: Argentina
facility: Hospital Dr. T. Alvarez
state: Dr. Juan Felipe Aranguren 2701, Cuidad Autónoma de B.A.
city: Buenos Aires
country: Argentina
facility: Hospital Materno Infantil Ramón Sardá
state: Esteban De Luca 2151, Ciudad Autónoma de Buenos Aires
city: Buenos Aires
country: Argentina
facility: Hospital Municipal Materno Infantil Comodoro Meisner
state: Iparaguirre Nº 239, Pte. Derqui, Provincia de Buenos Aires
city: Buenos Aires
country: Argentina
facility: Hospital Italiano de Buenos Aires
state: Juan D. Perón 4190, Ciudad Autónoma de Buenos Aires
city: Buenos Aires
country: Argentina
facility: Hospital Materno Infantil San Roque
state: La Paz 435, Provincia de Entre Ríos
city: Buenos Aires
country: Argentina
facility: Hospital Municipal Ostaciana B. de Lavignolle
state: Monte 848, Morón, Provincia de Buenos Aires
city: Buenos Aires
country: Argentina
facility: Hospital J. M. Penna
state: Pedro Chutro 3380, Cuidad Autónoma de Buenos Aires
city: Buenos Aires
country: Argentina
facility: Hospital Donación Francisco Santojanni
state: Pilar 950, Ciudad Autónoma de Buenos Aires
city: Buenos Aires
country: Argentina
facility: Hospital Dr. Cosme Argerich
state: Py y Margall 750, Cuidad Autónoma de Buenos Aires
city: Buenos Aires
country: Argentina
facility: Hospital Dr. Arturo Oñativia
state: Ramón Carillo 1339, Rafael Calzada, Provincia de Buenos Aires
city: Buenos Aires
country: Argentina
facility: Hospital Héroes de Malvinas
state: Ricardo Balbín 1910, Merlo, Provincia de Buenos Aires
city: Buenos Aires
country: Argentina
facility: Hospital Magdalena V. de Martínez
state: Rura 9 Constituyentes 395, Gral, Pacheco, Provincia de B.A.
city: Buenos Aires
country: Argentina
facility: Hospital Dr. Carlos Bocalandro
state: Ruta 8Km. 20,5 n°9100, Loma Hermosa, Provincia de Buenos Aires
city: Basel
country: Switzerland
facility: Universitäts-Frauenklinik Kantonespital Basel
city: Bern
country: Switzerland
facility: Universitätsfrauenklinik Bern
city: Chur
country: Switzerland
facility: Kantonales Frauenspital Chur
city: Geneva
country: Switzerland
facility: Maternity of the University Hospital of Geneva
city: Lausanne
country: Switzerland
facility: Centre Hospitalier Universitaire Vaudois
city: Luzern
country: Switzerland
facility: Frauenklinik Kantonspital Luzern
city: St Gallen
country: Switzerland
facility: Frauenklinik Kantonspital St Gallen
city: Winterthur
country: Switzerland
facility: Frauenklinik Kantonspital Winterthur
city: Zurich
country: Switzerland
facility: University Hospital Zürich
Study officials:
affiliation: University Hospital, Geneva
name: Begona Martinez de Tejada, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Martinez de Tejada B, Karolinski A, Ocampo MC, Laterra C, Hosli I, Fernandez D, Surbek D, Huespe M, Drack G, Bunader A, Rouillier S, Lopez de Degani G, Seidenstein E, Prentl E, Anton J, Krahenmann F, Nowacki D, Poncelas M, Nassif JC, Papera R, Tuma C, Espoile R, Tiberio O, Breccia G, Messina A, Peker B, Schinner E, Mol BW, Kanterewicz L, Wainer V, Boulvain M, Othenin-Girard V, Bertolino MV, Irion O; 4P trial group. Prevention of preterm delivery with vaginal progesterone in women with preterm labour (4P): randomised double-blind placebo-controlled trial. BJOG. 2015 Jan;122(1):80-91. doi: 10.1111/1471-0528.13061. Epub 2014 Sep 11.