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

Primary Purpose

Preterm Delivery, Morbidity, Perinatal Mortality

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
progesterone
placebo
Sponsored by
begoña Martinez de Tejada
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Preterm Delivery focused on measuring preterm delivery, preterm labor, perinatal morbidity, perinatal mortality

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital Interzonal Alberto Antranik Eurnekian
  • Hospital Carlos G. Durand
  • Instituto Universitario CEMIC
  • Hospital Bernardino Rivadavia
  • Hospital Mariano y Luciano de la Vega
  • Hospital Maternidad Nuestra Señora De Las Mercedes
  • Hospital Villa Dolores
  • Hospital J. B. Iturraspe
  • Hospital Comunal de Tigre
  • Hospital Materno Infantil de San Isidro
  • Hospital Virgen del Carmen
  • Hospital Dr. T. Alvarez
  • Hospital Materno Infantil Ramón Sardá
  • Hospital Municipal Materno Infantil Comodoro Meisner
  • Hospital Italiano de Buenos Aires
  • Hospital Materno Infantil San Roque
  • Hospital Municipal Ostaciana B. de Lavignolle
  • Hospital J. M. Penna
  • Hospital Donación Francisco Santojanni
  • Hospital Dr. Cosme Argerich
  • Hospital Dr. Arturo Oñativia
  • Hospital Héroes de Malvinas
  • Hospital Magdalena V. de Martínez
  • Hospital Dr. Carlos Bocalandro
  • Universitäts-Frauenklinik Kantonespital Basel
  • Universitätsfrauenklinik Bern
  • Kantonales Frauenspital Chur
  • Maternity of the University Hospital of Geneva
  • Centre Hospitalier Universitaire Vaudois
  • Frauenklinik Kantonspital Luzern
  • Frauenklinik Kantonspital St Gallen
  • Frauenklinik Kantonspital Winterthur
  • University Hospital Zürich

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

The principal aim is to demonstrate that progesterone reduces preterm birth before 37 weeks of gestation

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

Full Information

First Posted
September 24, 2007
Last Updated
June 5, 2012
Sponsor
begoña Martinez de Tejada
Collaborators
Centre Hospitalier Universitaire Vaudois, Insel Gruppe AG, University Hospital Bern, Basel Women's University Hospital, University of Zurich, Kantonsspital Graubuenden, 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, Hospital General de Agudos "Dr. Cosme Argerich", Hospital Dr. T. Alvarez Buenos Aires, Hospital Italiano de Buenos Aires, Hospital J. M. Penna Buenos Aires, Hospital Materno Infantil Ramón Sardá, 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 Provincial Magdalena V. de Martínez, 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
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1. Study Identification

Unique Protocol Identification Number
NCT00536003
Brief Title
Vaginal Progesterone to Prevent Preterm Delivery in Women With Preterm Labor
Acronym
4P
Official Title
Prevention of Preterm Delivery With Vaginal Progesterone in Women With Preterm Labor
Study Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Terminated
Study Start Date
July 2006 (undefined)
Primary Completion Date
December 2012 (Anticipated)
Study Completion Date
December 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
begoña Martinez de Tejada
Collaborators
Centre Hospitalier Universitaire Vaudois, Insel Gruppe AG, University Hospital Bern, Basel Women's University Hospital, University of Zurich, Kantonsspital Graubuenden, 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, Hospital General de Agudos "Dr. Cosme Argerich", Hospital Dr. T. Alvarez Buenos Aires, Hospital Italiano de Buenos Aires, Hospital J. M. Penna Buenos Aires, Hospital Materno Infantil Ramón Sardá, 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 Provincial Magdalena V. de Martínez, 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

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm Delivery, Morbidity, Perinatal Mortality
Keywords
preterm delivery, preterm labor, perinatal morbidity, perinatal mortality

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
384 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
progesterone
Other Intervention Name(s)
Utrogestan
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
vaginal capsules containing placebo, once a day, until 36 6/7 weeks of gestation or until preterm delivery (whichever occurs first).
Primary Outcome Measure Information:
Title
The principal aim is to demonstrate that progesterone reduces preterm birth before 37 weeks of gestation
Time Frame
end of pregnancy
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Begona Martinez de Tejada, MD, PhD
Organizational Affiliation
University Hospital, Geneva
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Interzonal Alberto Antranik Eurnekian
City
Buenos Aires
State/Province
Alem 349, Ezeiza, Provincia de Buenos Aires
Country
Argentina
Facility Name
Hospital Carlos G. Durand
City
Buenos Aires
State/Province
Av. Diaz Velez 5044, Cuidad Autónoma de Buenos Aires
Country
Argentina
Facility Name
Instituto Universitario CEMIC
City
Buenos Aires
State/Province
Av. E. Galván 4102, Ciudad Autónoma de Buenos Aires
Country
Argentina
Facility Name
Hospital Bernardino Rivadavia
City
Buenos Aires
State/Province
Av. Las Heras 2670, Cuidad Autónoma de Buenos Aires
Country
Argentina
Facility Name
Hospital Mariano y Luciano de la Vega
City
Buenos Aires
State/Province
Av. Libertador 710, Moreno, Provincia de Buenos Aires
Country
Argentina
Facility Name
Hospital Maternidad Nuestra Señora De Las Mercedes
City
Buenos Aires
State/Province
Av. Mate de Luna 1555, Provincia de Tucumán
Country
Argentina
Facility Name
Hospital Villa Dolores
City
Buenos Aires
State/Province
Belgrano 1500, Villa Dolores, Provincia de Códoba
Country
Argentina
Facility Name
Hospital J. B. Iturraspe
City
Buenos Aires
State/Province
Bvd. Pellegrini 3551, Provincia de Santa Fe
Country
Argentina
Facility Name
Hospital Comunal de Tigre
City
Buenos Aires
State/Province
Casareto 118, Tigre, Provincia de Buenos Aires
Country
Argentina
Facility Name
Hospital Materno Infantil de San Isidro
City
Buenos Aires
State/Province
Diego Palma 505, San Isidro, Provincia de Buenos Aires
Country
Argentina
Facility Name
Hospital Virgen del Carmen
City
Buenos Aires
State/Province
Dr. Félix Pagola 1502, Zárate, Provincia de Buenos Aires
Country
Argentina
Facility Name
Hospital Dr. T. Alvarez
City
Buenos Aires
State/Province
Dr. Juan Felipe Aranguren 2701, Cuidad Autónoma de B.A.
Country
Argentina
Facility Name
Hospital Materno Infantil Ramón Sardá
City
Buenos Aires
State/Province
Esteban De Luca 2151, Ciudad Autónoma de Buenos Aires
Country
Argentina
Facility Name
Hospital Municipal Materno Infantil Comodoro Meisner
City
Buenos Aires
State/Province
Iparaguirre Nº 239, Pte. Derqui, Provincia de Buenos Aires
Country
Argentina
Facility Name
Hospital Italiano de Buenos Aires
City
Buenos Aires
State/Province
Juan D. Perón 4190, Ciudad Autónoma de Buenos Aires
Country
Argentina
Facility Name
Hospital Materno Infantil San Roque
City
Buenos Aires
State/Province
La Paz 435, Provincia de Entre Ríos
Country
Argentina
Facility Name
Hospital Municipal Ostaciana B. de Lavignolle
City
Buenos Aires
State/Province
Monte 848, Morón, Provincia de Buenos Aires
Country
Argentina
Facility Name
Hospital J. M. Penna
City
Buenos Aires
State/Province
Pedro Chutro 3380, Cuidad Autónoma de Buenos Aires
Country
Argentina
Facility Name
Hospital Donación Francisco Santojanni
City
Buenos Aires
State/Province
Pilar 950, Ciudad Autónoma de Buenos Aires
Country
Argentina
Facility Name
Hospital Dr. Cosme Argerich
City
Buenos Aires
State/Province
Py y Margall 750, Cuidad Autónoma de Buenos Aires
Country
Argentina
Facility Name
Hospital Dr. Arturo Oñativia
City
Buenos Aires
State/Province
Ramón Carillo 1339, Rafael Calzada, Provincia de Buenos Aires
Country
Argentina
Facility Name
Hospital Héroes de Malvinas
City
Buenos Aires
State/Province
Ricardo Balbín 1910, Merlo, Provincia de Buenos Aires
Country
Argentina
Facility Name
Hospital Magdalena V. de Martínez
City
Buenos Aires
State/Province
Rura 9 Constituyentes 395, Gral, Pacheco, Provincia de B.A.
Country
Argentina
Facility Name
Hospital Dr. Carlos Bocalandro
City
Buenos Aires
State/Province
Ruta 8Km. 20,5 n°9100, Loma Hermosa, Provincia de Buenos Aires
Country
Argentina
Facility Name
Universitäts-Frauenklinik Kantonespital Basel
City
Basel
ZIP/Postal Code
4031
Country
Switzerland
Facility Name
Universitätsfrauenklinik Bern
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Facility Name
Kantonales Frauenspital Chur
City
Chur
ZIP/Postal Code
7000
Country
Switzerland
Facility Name
Maternity of the University Hospital of Geneva
City
Geneva
ZIP/Postal Code
1211
Country
Switzerland
Facility Name
Centre Hospitalier Universitaire Vaudois
City
Lausanne
ZIP/Postal Code
1011
Country
Switzerland
Facility Name
Frauenklinik Kantonspital Luzern
City
Luzern
Country
Switzerland
Facility Name
Frauenklinik Kantonspital St Gallen
City
St Gallen
ZIP/Postal Code
9007
Country
Switzerland
Facility Name
Frauenklinik Kantonspital Winterthur
City
Winterthur
ZIP/Postal Code
8401
Country
Switzerland
Facility Name
University Hospital Zürich
City
Zurich
ZIP/Postal Code
8091
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
25209926
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.
Results Reference
derived

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Vaginal Progesterone to Prevent Preterm Delivery in Women With Preterm Labor

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