Prevention of Preterm Birth Using Cervical Pessary in Pregnant Women With Short Cervix in Twins

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

PHASE4

Total Enrollment

137 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2014-07-31

Brief Summary

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Placement of a vaginal pessary reduces significantly the rate of spontaneous preterm birth in pregnant women with twins and a short cervical length at 18-22 weeks scan.

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Detailed Description

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This trial includes pregnant women with twins undergoing routine ultrasound examination at 18.0 to 22.6 weeks of gestation.

Conditions

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Preterm Birth

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Expectant Management

Group Type NO_INTERVENTION

No interventions assigned to this group

Placement of cervical pessary since 23 weeks until 37 weeks

Group Type EXPERIMENTAL

Silicon ring (Arabin Cervical Pessary)

Intervention Type DEVICE

Vaginal pessaries CE 0482 MED / CERT ISO 9003 /EN 46003

Interventions

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Silicon ring (Arabin Cervical Pessary)

Vaginal pessaries CE 0482 MED / CERT ISO 9003 /EN 46003

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Twins
* Minimal age of 18 years

Exclusion Criteria

* Major fetal abnormalities (requiring surgery or leading to infant death or severe handicap)
* Spontaneous rupture of membranes at the time of randomization
* Cervical cerclage in situ
* Active vaginal bleeding
* Placenta previa

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No