Vaginal Progesterone to Prevent Preterm Delivery in Women With Preterm Labor
NCT ID: NCT00536003
Last Updated: 2012-06-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
384 participants
INTERVENTIONAL
2006-07-31
2012-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
PREVENTION
QUADRUPLE
Study Groups
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1
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).
2
placebo
vaginal capsules containing placebo, once a day, until 36 6/7 weeks of gestation or until preterm delivery (whichever occurs first).
Interventions
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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).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
FEMALE
No
Sponsors
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Centre Hospitalier Universitaire Vaudois
OTHER
Insel Gruppe AG, University Hospital Bern
OTHER
Basel Women's University Hospital
OTHER
University of Zurich
OTHER
Kantonsspital Graubuenden
OTHER
Cantonal Hospital of St. Gallen
OTHER
Luzerner Kantonsspital
OTHER
Kantonsspital Winterthur KSW
OTHER
Besins Laboratory, Belgium
UNKNOWN
Hospital Bernardino Rivadavia Buenos Aires
UNKNOWN
Hospital Carlos G. Durand Buenos Aires
UNKNOWN
CEMIC Buenos Aires
UNKNOWN
Hospital Donación Francisco Santojanni
OTHER
Hospital General de Agudos "Dr. Cosme Argerich"
OTHER
Hospital Dr. T. Alvarez Buenos Aires
UNKNOWN
Hospital Italiano de Buenos Aires
OTHER
Hospital J. M. Penna Buenos Aires
UNKNOWN
Hospital Materno Infantil Ramón Sardá
NETWORK
Hospital Interzonal Alberto Antranik Eurnekian, provincia Buenos Aires
UNKNOWN
Hospital Municipal Materno Infantil Comodoro Hugo Cesar Meisner, provincia Buenos Aires
UNKNOWN
Hospital Comunal de Tigre, provincia Buenos Aires
UNKNOWN
Hospital Dr. Arturo Oñativia, provincia Buenos Aires
UNKNOWN
Hospital Dr. Carlos Bocalandro, provincia Buenos Aires
UNKNOWN
Hospital Héroes de Malvinas, provincia Buenos Aires
UNKNOWN
Hospital Provincial Magdalena V. de Martínez
OTHER
Hospital Mariano y Luciano de la Vega, provincia Buenos Aires
UNKNOWN
Hospital Municipal Ostaciana B. de Lavignolle, provincia Buenos Aires
UNKNOWN
Hospital Materno Infantil de San Isidro, provincia Buenos Aires
UNKNOWN
Hospital Virgen del Carmen, provincia Buenos Aires
UNKNOWN
Hospital J. B. Iturraspe, Santa Fe
UNKNOWN
Hospital Maternidad Nuestra Señora De Las Mercedes, Tucumán
UNKNOWN
Hospital Materno Infantil San Roque, Entre Ríos
UNKNOWN
Hospital Villa Dolores, Córdoba
UNKNOWN
begoña Martinez de Tejada
OTHER
Responsible Party
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begoña Martinez de Tejada
MD, PhD
Principal Investigators
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Begona Martinez de Tejada, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Geneva
Locations
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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
Universitäts-Frauenklinik Kantonespital Basel
Basel, Basel, Switzerland
Universitätsfrauenklinik Bern
Bern, Canton of Bern, Switzerland
Maternity of the University Hospital of Geneva
Geneva, Canton of Geneva, Switzerland
Frauenklinik Kantonspital Luzern
Lucerne, Canton of Lucerne, Switzerland
Frauenklinik Kantonspital St Gallen
Sankt Gallen, Canton of St. Gallen, Switzerland
University Hospital Zürich
Zurich, Canton of Zurich, Switzerland
Kantonales Frauenspital Chur
Chur, Chur, Switzerland
Centre Hospitalier Universitaire Vaudois
Lausanne, Lausanne, Switzerland
Frauenklinik Kantonspital Winterthur
Winterthur, Winterthur, Switzerland
Countries
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References
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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.
Other Identifiers
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matped 04-001
Identifier Type: -
Identifier Source: secondary_id
CER: 04-196
Identifier Type: -
Identifier Source: org_study_id
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