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

• Sponsor: Assistance Publique - Hôpitaux de Paris (Other)
• Overall Status: Completed
• CT.gov ID: NCT00502190
• Collaborator: (none)
• Enrollment: 220
• Location: 1
• Arms: 2
• Duration (Months): 48
• Patients Per Site Per Month: 4.6

Study Details

Study Description

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 Design

• Study Type: Interventional
• 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: Jun 1, 2007
• Actual Primary Completion Date: Jun 1, 2011
• Actual Study Completion Date: Jun 1, 2011

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

1. To evaluate and compare the frequency of the childbirth < 34 SA [before 34 weeks]

2. Deliveries (<34WG) [34 weeks]

   Deliveries (<34WG)

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

   Evaluate the rate of side effects of pessaries

4. Neonatal outcome [before 28 weeks]

   Neonatal outcome

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Assistance Publique - Hôpitaux de Paris
• ClinicalTrials.gov Identifier: NCT00502190
• Other Study ID Numbers: P050322
• First Posted: Jul 17, 2007
• Last Update Posted: Nov 10, 2011
• Last Verified: Apr 1, 2007

• Keywords provided by Assistance Publique - Hôpitaux de Paris: pessary; extending pregnancy
• Additional relevant MeSH terms: Silicon

Study Results

No Results Posted as of Nov 10, 2011