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

Study Overview
=================
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.

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

Conditions
-----------------
Twin Pregnancy

Intervention / Treatment
-----------------
* Device: Silicon ring positioned in the vagina, around the cervix


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Silicon ring positioned in the vagina, around the cervix | Device: Silicon ring positioned in the vagina, around the cervix<br>* Silicon ring positioned in the vagina, around the cervix<br>|
| Experimental: 2<br>Silicon ring positioned in the vagina, around the cervix | Device: Silicon ring positioned in the vagina, around the cervix<br>* Silicon ring positioned in the vagina, around the cervix<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate and compare the frequency of the childbirth < 34 SA |  | before 34 weeks | 
| Deliveries (<34WG) | Deliveries (<34WG) | 34 weeks | 
| Evaluate the rate of side effects of pessaries | Evaluate the rate of side effects of pessaries | during the pessaries | 
| Neonatal outcome | Neonatal outcome | before 28 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pessary, extending pregnancy