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

Maternal-Infantil Vall d´Hebron Hospital

Status: Completed

Conditions: Preterm Birth

Treatments: Device: Silicon ring (Arabin Pessary)

Study type: Interventional

Funder types: Other

Identifiers

NCT00706264

PECEP-TRIAL

Details and patient eligibility

About

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.

Full description

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

Enrollment: 385 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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385 participants in 2 patient groups

1

No Intervention group

Description:

Expectant management

2

Experimental group

Description:

Placement of arabin pessary since 23 weeks until 37 weeks

Treatment:

Device: Silicon ring (Arabin Pessary)