Efficacy of 17 Alpha-hydroxyprogesterones Caproate for the Prevention of Preterm Delivery

Evaluation of the Efficacy of 17 Alpha-hydroxyprogesterones Caproate for the Prevention of Preterm Delivery

To demonstrate that the intramuscular administration of 17 alpha hydroxyprogesterones caproate allows to reduce the risk of preterm delivery, in 3 high risk populations defined by the association of an ultrasonographic cervical length egal and inferiority 26 mm between 20 and 32 weeks of gestation and:

  • either a first episode of preterm labor stopped by acute tocolysis;
  • either a history of late miscarriage or premature delivery or uterine malformation or DES
  • either a twin pregnancy. Therefore, a randomised, multicentre trial has been designed with initial stratification according to these three risk groups, opened with two parallel arms.

Study Overview

Status

Completed

Conditions

Detailed Description

Objective

To demonstrate that the intramuscular administration of 17 alpha - hydroxyprogesterones caproate allows to reduce the risk of preterm delivery, in 3 high risk populations defined by the association of an ultrasonographic cervical length 26 mm between 20 and 32 weeks of gestation and:

  • either a first episode of preterm labor stopped by acute tocolysis;
  • either a history of late miscarriage or premature delivery or uterine malformation or DES
  • either a twin pregnancy. Experimental design Prospective, randomized, multicenter, trial with initial stratification according to three risk groups, opened with two parallel arms.

The maximal duration for treatment will be 16 weeks for each included patient. The duration for inclusions will be 30 months. The duration for participation of each patient will be 10 to 22 weeks. The foreseen inclusion period for this trial is from 06/01/2006 to 12/31/2008 Description Two therapeutic strategies will be compared in each risk group and attributed by uniform randomisation.

Arm A :IM injection of 17 alpha hydroxyprogesterones caproate, 500 mg, twice a week until 36 W or until preterm delivery in high risk symptomatic group and high risk twin pregnancies group.

IM injection of 17 alpha-hydroxyprogesterones caproate, 500 mg, once a week until 36 W or until preterm delivery in high risk asymptomatic group.

Arm B :No treatment with 17 alpha-hydroxyprogesterones caproate. (usual management) Presentation : Progesterone retard Pharlon 500 mg Tolerance criteria

  • nausea,vomiting,
  • weakness

Study Type

Interventional

Enrollment (Actual)

560

Phase

  • Phase 4

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

      • Poissy, France, 78303
        • Chi Poissy St Germain
      • Poissy, France, 78
        • Chi Poissy St Germain

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

Ages Eligible for Study

18 years to 49 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • ultrasonographic cervical length 26 mm between 20 and 32 weeks of gestation and:
  • either a first episode of preterm labor stopped by acute tocolysis
  • either a history of late miscarriage or premature delivery or uterine malformation or DES;
  • either a twin pregnancy.

Exclusion Criteria:

  • cervical dilatation > 3 cm,
  • chorioamnionitis,
  • fetal distress,
  • placenta praevia,
  • abruptio placenta,
  • preterm premature rupture of membranes,
  • polyhydramnios,
  • Twin-twin transfusion syndrome,
  • IUGR,
  • preeclampsia or hypertension,
  • other pathology justifying a preterm delivery,
  • epilepsy drugs
  • participation to another therapeutic trial,
  • any patient for whom informed consent cannot be obtained.

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: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
17 alpha-hydroxyprogesterones caproate
17 alpha-hydroxyprogesterones caproate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Interval between inclusion and delivery.
Time Frame: during de study
Interval between inclusion and delivery.
during de study

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Preterm delivery rate < 37 W, < 34 W et < 32 W,
Time Frame: during the study
Preterm delivery rate < 37 W, < 34 W et < 32 W,
during the study
Number of hospitalizations for preterm labor,
Time Frame: during the study
Number of hospitalizations for preterm labor,
during the study
Cerclage performed at or after 20 weeks,
Time Frame: during the study
Cerclage performed at or after 20 weeks,
during the study
Neonatal weight,
Time Frame: during the study
Neonatal weight,
during the study
NICU transport
Time Frame: during the study
NICU transport
during the study
Respiratory distress syndrome,
Time Frame: during the study
Respiratory distress syndrome,
during the study
Bronchopulmonary dysplasia,
Time Frame: during the study
Bronchopulmonary dysplasia,
during the study
Necrotizing enterocolitis,
Time Frame: during the study
Necrotizing enterocolitis,
during the study
leucomalacia,
Time Frame: during the study
leucomalacia,
during the study
neonatal death.
Time Frame: during the study
neonatal death.
during the study

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Patrick ROZENBERG, MD,, Assistance Publique - Hôpitaux de Paris

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.

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

June 1, 2006

Primary Completion (ACTUAL)

May 1, 2010

Study Completion (ACTUAL)

May 1, 2010

Study Registration Dates

First Submitted

May 30, 2006

First Submitted That Met QC Criteria

May 30, 2006

First Posted (ESTIMATE)

May 31, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

May 9, 2011

Last Update Submitted That Met QC Criteria

May 6, 2011

Last Verified

March 1, 2007

More Information

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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