Evaluation Of Pessaries In Twin Pregnancies With A Short Cervix (25 mm) Between 20-28 WG (EPEGE) (EPEGE)

November 9, 2011 updated by: Assistance Publique - Hôpitaux de Paris

Evaluation Of Pessaries In Twin Pregnancies With A Short Cervix (25 mm) Between 20-28 WG

Randomized, opened multicentric study evaluating the Effectiveness of Pessary in the patients with a Gemellary pregnancy and a collar runs between 20 and 28 weeks of amenorrhoea

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Randomized, opened multicentric study evaluating the Effectiveness of Pessary in the patients with a Gemellary pregnancy and a collar runs between 20 and 28 weeks of amenorrhoea To show that the use of pessary makes it possible to lengthen the duration of the pregnancy of at least 10 days in patients with a twin pregnancy and a uterine collar length < = 25 mm measured by echography between 20 and 28 SA compared to the group controls.

Study Type

Interventional

Enrollment (Actual)

220

Phase

  • 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

  • France
      • Poissy, France, 78300
        • Hopital POISSY-ST GERMAIN EN LAYE

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Age > 18 years (legal majority in France)
  • Inclusion pessary positioning before 28 WG
  • Twin pregnancies, mono or dichorionic, diamniotic
  • Transvaginal cervical length ( 25mm between 20 et 28 WG
  • Intact membranes
  • No signs of infection (negative urine culture, CRP <10mg/l , blood white cell count <15000/ml)
  • Patient accepting follow-up
  • Covered by health insurance for France

Exclusion Criteria:

  • Cerclage

    • No more cervix
    • Chorioamnionitis
    • Abnormal CTG
    • Placenta praevia
    • Abruptio
    • Bleeding
    • PROM
    • Singleton or multiple >2
    • Monochorionic monoamniotic twin pregnancy
    • IUGR
    • Preeclampsia or other PIH
    • TTTS
    • Uncontrolled diabetes
    • Other maternal of fetal pathology responsible for preterm deliveries
    • Patient included in other therapeutic trials
    • Patient without legal freedom to consent
    • Homeless or no fixed address

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: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Silicon ring positioned in the vagina, around the cervix
Device: Silicon ring positioned in the vagina, around the cervix
Silicon ring positioned in the vagina, around the cervix
Experimental: 2
Silicon ring positioned in the vagina, around the cervix
Device: Silicon ring positioned in the vagina, around the cervix
Silicon ring positioned in the vagina, around the cervix

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Demonstrate the profit of 10 days in the pessary group compared to control.
Time Frame: at least 10 days
Demonstrate the profit of 10 days in the pessary group compared to control
at least 10 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To evaluate and compare the frequency of the childbirth < 34 SA
Time Frame: before 34 weeks
before 34 weeks
Deliveries (<34WG)
Time Frame: 34 weeks
Deliveries (<34WG)
34 weeks
Evaluate the rate of side effects of pessaries
Time Frame: during the pessaries
Evaluate the rate of side effects of pessaries
during the pessaries
Neonatal outcome
Time Frame: before 28 weeks
Neonatal outcome
before 28 weeks

Collaborators and Investigators

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

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: Jacky NIZARD, CCA, Assistance Publique - Hôpitaux de Paris

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, 2007

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

July 16, 2007

First Submitted That Met QC Criteria

July 16, 2007

First Posted (Estimate)

July 17, 2007

Study Record Updates

Last Update Posted (Estimate)

November 10, 2011

Last Update Submitted That Met QC Criteria

November 9, 2011

Last Verified

April 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P050322

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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