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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00502190
First received: July 16, 2007
Last updated: November 9, 2011
Last verified: April 2007
  Purpose

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 Intervention Phase
Twin Pregnancy
Device: Silicon ring positioned in the vagina, around the cervix
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Evaluation Of Pessaries In Twin Pregnancies With A Short Cervix (25 mm) Between 20-28 WG

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Demonstrate the profit of 10 days in the pessary group compared to control. [ Time Frame: at least 10 days ] [ Designated as safety issue: Yes ]
    Demonstrate the profit of 10 days in the pessary group compared to control


Secondary Outcome Measures:
  • To evaluate and compare the frequency of the childbirth < 34 SA [ Time Frame: before 34 weeks ] [ Designated as safety issue: Yes ]
  • Deliveries (<34WG) [ Time Frame: 34 weeks ] [ Designated as safety issue: Yes ]
    Deliveries (<34WG)

  • Evaluate the rate of side effects of pessaries [ Time Frame: during the pessaries ] [ Designated as safety issue: Yes ]
    Evaluate the rate of side effects of pessaries

  • Neonatal outcome [ Time Frame: before 28 weeks ] [ Designated as safety issue: Yes ]
    Neonatal outcome


Enrollment: 220
Study Start Date: June 2007
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Name: 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
Other Name: Silicon ring positioned in the vagina, around the cervix

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00502190     History of Changes
Other Study ID Numbers: P050322
Study First Received: July 16, 2007
Last Updated: November 9, 2011
Health Authority: France: Ministry of Health

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
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 29, 2014