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

NCT ID: NCT00502190

Last Updated: 2011-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-30

Study Completion Date

2011-06-30

Brief Summary

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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

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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.

Conditions

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Twin Pregnancy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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1

Silicon ring positioned in the vagina, around the cervix

Group Type EXPERIMENTAL

Silicon ring positioned in the vagina, around the cervix

Intervention Type DEVICE

Silicon ring positioned in the vagina, around the cervix

2

Silicon ring positioned in the vagina, around the cervix

Group Type EXPERIMENTAL

Silicon ring positioned in the vagina, around the cervix

Intervention Type DEVICE

Silicon ring positioned in the vagina, around the cervix

Interventions

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Silicon ring positioned in the vagina, around the cervix

Silicon ring positioned in the vagina, around the cervix

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jacky NIZARD, CCA

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

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Hopital POISSY-ST GERMAIN EN LAYE

Poissy, , France

Site Status

Countries

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France

Other Identifiers

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P050322

Identifier Type: -

Identifier Source: org_study_id