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

Assistance Publique - Hôpitaux de Paris220 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

220

Conditions

Twin Pregnancy

Interventions

Silicon ring positioned in the vagina, around the cervixDEVICE

Silicon ring positioned in the vagina, around the cervix

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Hopital POISSY-ST GERMAIN EN LAYE

Poissy, France

Outcomes

Primary Outcomes

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

Time frame: at least 10 days

Secondary Outcomes

To evaluate and compare the frequency of the childbirth < 34 SA

Time frame: before 34 weeks

Deliveries (<34WG)

Deliveries (\<34WG)

Time frame: 34 weeks

Evaluate the rate of side effects of pessaries

Time frame: during the pessaries

Neonatal outcome

Time frame: before 28 weeks

Data from ClinicalTrials.gov

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