Evaluation Of Pessaries In Twin Pregnancies With A Short Cervix (25 mm) Between 20-28 WG (EPEGE)
EPEGE
1 other identifier
interventional
220
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jun 2007
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2007
CompletedFirst Submitted
Initial submission to the registry
July 16, 2007
CompletedFirst Posted
Study publicly available on registry
July 17, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedNovember 10, 2011
April 1, 2007
4 years
July 16, 2007
November 9, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Demonstrate the profit of 10 days in the pessary group compared to control.
Demonstrate the profit of 10 days in the pessary group compared to control
at least 10 days
Secondary Outcomes (4)
To evaluate and compare the frequency of the childbirth < 34 SA
before 34 weeks
Deliveries (<34WG)
34 weeks
Evaluate the rate of side effects of pessaries
during the pessaries
Neonatal outcome
before 28 weeks
Study Arms (2)
1
EXPERIMENTALSilicon ring positioned in the vagina, around the cervix
2
EXPERIMENTALSilicon ring positioned in the vagina, around the cervix
Interventions
Silicon ring positioned in the vagina, around the cervix
Eligibility Criteria
You may qualify if:
- Age \> 18 years (legal majority in France)
- 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
You may not qualify if:
- 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
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hopital POISSY-ST GERMAIN EN LAYE
Poissy, 78300, France
Study Officials
- PRINCIPAL INVESTIGATOR
Jacky NIZARD, CCA
Assistance Publique - Hôpitaux de Paris
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 16, 2007
First Posted
July 17, 2007
Study Start
June 1, 2007
Primary Completion
June 1, 2011
Study Completion
June 1, 2011
Last Updated
November 10, 2011
Record last verified: 2007-04