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

Phase 3

Completed

• Conditions: Twin Pregnancy
• Interventions: Device: Silicon ring positioned in the vagina, around the cervix

• Registration Number: NCT00502190
• Lead Sponsor: 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

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 Timeline

• Status Verified: 2007-04
• Study Start: 2007-06
• Study First Submitted: 2007-07-16
• Study First Submitted QC: 2007-07-16
• Study First Posted: 2007-07-17
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Last Update Submitted: 2011-11-09
• Last Update Posted: 2011-11-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 220

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Silicon ring positioned in the vagina, around the cervix	Silicon ring positioned in the vagina, around the cervix
2	Silicon ring positioned in the vagina, around the cervix	Silicon ring positioned in the vagina, around the cervix

Primary Outcome Measures

Name	Time	Method
Demonstrate the profit of 10 days in the pessary group compared to control.	at least 10 days	Demonstrate the profit of 10 days in the pessary group compared to control

Secondary Outcome Measures

Name	Time	Method
To evaluate and compare the frequency of the childbirth < 34 SA	before 34 weeks
Deliveries (<34WG)	34 weeks	Deliveries (\<34WG)
Evaluate the rate of side effects of pessaries	during the pessaries	Evaluate the rate of side effects of pessaries
Neonatal outcome	before 28 weeks	Neonatal outcome

Trial Locations

Locations (1)

Hopital POISSY-ST GERMAIN EN LAYE; 🇫🇷 Poissy, France