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

June 5, 2012 updated by: begoña Martinez de Tejada, Begona Martinez de Tejada

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
384

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
    • Alem 349, Ezeiza, Provincia de Buenos Aires
      • Buenos Aires, Alem 349, Ezeiza, Provincia de Buenos Aires, Argentina
        • Hospital Interzonal Alberto Antranik Eurnekian
    • Av. Diaz Velez 5044, Cuidad Autónoma de Buenos Aires
      • Buenos Aires, Av. Diaz Velez 5044, Cuidad Autónoma de Buenos Aires, Argentina
        • Hospital Carlos G. Durand
    • Av. E. Galván 4102, Ciudad Autónoma de Buenos Aires
      • Buenos Aires, Av. E. Galván 4102, Ciudad Autónoma de Buenos Aires, Argentina
        • Instituto Universitario CEMIC
    • Av. Las Heras 2670, Cuidad Autónoma de Buenos Aires
      • Buenos Aires, Av. Las Heras 2670, Cuidad Autónoma de Buenos Aires, Argentina
        • Hospital Bernardino Rivadavia
    • Av. Libertador 710, Moreno, Provincia de Buenos Aires
      • Buenos Aires, Av. Libertador 710, Moreno, Provincia de Buenos Aires, Argentina
        • Hospital Mariano y Luciano de la Vega
    • Av. Mate de Luna 1555, Provincia de Tucumán
      • Buenos Aires, Av. Mate de Luna 1555, Provincia de Tucumán, Argentina
        • Hospital Maternidad Nuestra Señora De Las Mercedes
    • Belgrano 1500, Villa Dolores, Provincia de Códoba
      • Buenos Aires, Belgrano 1500, Villa Dolores, Provincia de Códoba, Argentina
        • Hospital Villa Dolores
    • Bvd. Pellegrini 3551, Provincia de Santa Fe
      • Buenos Aires, Bvd. Pellegrini 3551, Provincia de Santa Fe, Argentina
        • Hospital J. B. Iturraspe
    • Casareto 118, Tigre, Provincia de Buenos Aires
      • Buenos Aires, Casareto 118, Tigre, Provincia de Buenos Aires, Argentina
        • Hospital Comunal de Tigre
    • Diego Palma 505, San Isidro, Provincia de Buenos Aires
      • Buenos Aires, Diego Palma 505, San Isidro, Provincia de Buenos Aires, Argentina
        • Hospital Materno Infantil de San Isidro
    • Dr. Félix Pagola 1502, Zárate, Provincia de Buenos Aires
      • Buenos Aires, Dr. Félix Pagola 1502, Zárate, Provincia de Buenos Aires, Argentina
        • Hospital Virgen del Carmen
    • Dr. Juan Felipe Aranguren 2701, Cuidad Autónoma de B.A.
      • Buenos Aires, Dr. Juan Felipe Aranguren 2701, Cuidad Autónoma de B.A., Argentina
        • Hospital Dr. T. Alvarez
    • Esteban De Luca 2151, Ciudad Autónoma de Buenos Aires
      • Buenos Aires, Esteban De Luca 2151, Ciudad Autónoma de Buenos Aires, Argentina
        • Hospital Materno Infantil Ramon Sardá
    • Iparaguirre Nº 239, Pte. Derqui, Provincia de Buenos Aires
      • Buenos Aires, Iparaguirre Nº 239, Pte. Derqui, Provincia de Buenos Aires, Argentina
        • Hospital Municipal Materno Infantil Comodoro Meisner
    • Juan D. Perón 4190, Ciudad Autónoma de Buenos Aires
      • Buenos Aires, Juan D. Perón 4190, Ciudad Autónoma de Buenos Aires, Argentina
        • Hospital Italiano de Buenos Aires
    • La Paz 435, Provincia de Entre Ríos
      • Buenos Aires, La Paz 435, Provincia de Entre Ríos, Argentina
        • Hospital Materno Infantil San Roque
    • Monte 848, Morón, Provincia de Buenos Aires
      • Buenos Aires, Monte 848, Morón, Provincia de Buenos Aires, Argentina
        • Hospital Municipal Ostaciana B. de Lavignolle
    • Pedro Chutro 3380, Cuidad Autónoma de Buenos Aires
      • Buenos Aires, Pedro Chutro 3380, Cuidad Autónoma de Buenos Aires, Argentina
        • Hospital J. M. Penna
    • Pilar 950, Ciudad Autónoma de Buenos Aires
      • Buenos Aires, Pilar 950, Ciudad Autónoma de Buenos Aires, Argentina
        • Hospital Donación Francisco Santojanni
    • Py y Margall 750, Cuidad Autónoma de Buenos Aires
      • Buenos Aires, Py y Margall 750, Cuidad Autónoma de Buenos Aires, Argentina
        • Hospital Dr. Cosme Argerich
    • Ramón Carillo 1339, Rafael Calzada, Provincia de Buenos Aires
      • Buenos Aires, Ramón Carillo 1339, Rafael Calzada, Provincia de Buenos Aires, Argentina
        • Hospital Dr. Arturo Oñativia
    • Ricardo Balbín 1910, Merlo, Provincia de Buenos Aires
      • Buenos Aires, Ricardo Balbín 1910, Merlo, Provincia de Buenos Aires, Argentina
        • Hospital Héroes de Malvinas
    • Rura 9 Constituyentes 395, Gral, Pacheco, Provincia de B.A.
      • Buenos Aires, Rura 9 Constituyentes 395, Gral, Pacheco, Provincia de B.A., Argentina
        • Hospital Magdalena V. de Martínez
    • Ruta 8Km. 20,5 n°9100, Loma Hermosa, Provincia de Buenos Aires
      • Buenos Aires, Ruta 8Km. 20,5 n°9100, Loma Hermosa, Provincia de Buenos Aires, Argentina
        • Hospital Dr. Carlos Bocalandro
  • Switzerland
      • Basel, Switzerland, 4031
        • Universitäts-Frauenklinik Kantonespital Basel
      • Bern, Switzerland, 3010
        • Universitätsfrauenklinik Bern
      • Chur, Switzerland, 7000
        • Kantonales Frauenspital Chur
      • Geneva, Switzerland, 1211
        • Maternity of the University Hospital of Geneva
      • Lausanne, Switzerland, 1011
        • Centre Hospitalier Universitaire Vaudois
      • Luzern, Switzerland
        • Frauenklinik Kantonspital Luzern
      • St Gallen, Switzerland, 9007
        • Frauenklinik Kantonspital St Gallen
      • Winterthur, Switzerland, 8401
        • Frauenklinik Kantonspital Winterthur
      • Zurich, Switzerland, 8091
        • University Hospital Zurich

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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).
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 Names:
  • Utrogestan

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
The principal aim is to demonstrate that progesterone reduces preterm birth before 37 weeks of gestation
Time Frame: end of pregnancy
end of pregnancy

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
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
end of pregnancy and 28 days after delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Begona Martinez de Tejada

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Hospital Italiano de Buenos Aires
University of Zurich
University Hospital Inselspital, Berne
Centre Hospitalier Universitaire Vaudois
Luzerner Kantonsspital
Cantonal Hospital of St. Gallen
Kantonsspital Winterthur KSW
Hospital Donación Francisco Santojanni
Hospital Provincial Magdalena V. de Martínez
Kantonsspital Graubuenden
Basel Women's University Hospital
Hospital Materno Infantil Ramón Sardá
Besins Laboratory, Belgium
Hospital Bernardino Rivadavia Buenos Aires
Hospital Carlos G. Durand Buenos Aires
CEMIC Buenos Aires
Hospital General de Agudos "Dr. Cosme Argerich"
Hospital Dr. T. Alvarez Buenos Aires
Hospital J. M. Penna 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 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

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Begona Martinez de Tejada, MD, PhD, University Hospital, Geneva

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2006

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2012

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 24, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 26, 2007

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 27, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 6, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 5, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CER: 04-196
  • matped 04-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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