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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

385 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-30

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 short cervical length at 18-22 weeks scan.

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Detailed Description

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This trial includes pregnant women 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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1

Expectant management

Group Type NO_INTERVENTION

No interventions assigned to this group

2

Placement of arabin pessary since 23 weeks until 37 weeks

Group Type EXPERIMENTAL

Silicon ring (Arabin Pessary)

Intervention Type DEVICE

Placement of a silicon pessary in the vagina, around the cervix.

Interventions

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Silicon ring (Arabin Pessary)

Placement of a silicon pessary in the vagina, around the cervix.

Intervention Type DEVICE

Other Intervention Names

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

Eligibility Criteria

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Inclusion Criteria

* Singleton pregnancy
* Minimal age of 18 years

Exclusion Criteria

* Major fetal abnormalities (requiring surgery or leading to infant death or severe handicap)
* SROM at the time of randomization
* Cervical cerclage in situ
* Active vaginal bleeding
* Previous cone biopsy or cerclage
* Major uterine structural anomalies
* Placenta previa

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No