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

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ClinicalTrials.gov Identifier: NCT00502190
Recruitment Status : Completed
First Posted : July 17, 2007
Last Update Posted : November 10, 2011
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Twin Pregnancy Device: Silicon ring positioned in the vagina, around the cervix Phase 3

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  (Clinical Trial)
Actual Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Evaluation Of Pessaries In Twin Pregnancies With A Short Cervix (25 mm) Between 20-28 WG
Study Start Date : June 2007
Actual Primary Completion Date : June 2011
Actual Study Completion Date : June 2011

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



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. To evaluate and compare the frequency of the childbirth < 34 SA [ Time Frame: before 34 weeks ]
  2. Deliveries (<34WG) [ Time Frame: 34 weeks ]
    Deliveries (<34WG)

  3. Evaluate the rate of side effects of pessaries [ Time Frame: during the pessaries ]
    Evaluate the rate of side effects of pessaries

  4. Neonatal outcome [ Time Frame: before 28 weeks ]
    Neonatal outcome



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00502190


Locations
France
Hopital POISSY-ST GERMAIN EN LAYE
Poissy, France, 78300
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Jacky NIZARD, CCA Assistance Publique - Hôpitaux de Paris

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00502190     History of Changes
Other Study ID Numbers: P050322
First Posted: July 17, 2007    Key Record Dates
Last Update Posted: November 10, 2011
Last Verified: April 2007

Keywords provided by Assistance Publique - Hôpitaux de Paris:
pessary
extending pregnancy

Additional relevant MeSH terms:
Silicon
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs