Prevention of Preterm Birth Using Cervical Pessary in Pregnant Women After Threatened Preterm Labor(PECEP-RETARD)

Maternal-Infantil Vall d´Hebron Hospital

Status and phase: Completed; Phase 4

Conditions: Preterm Birth

Treatments: Device: Device: Silicon ring (Arabin Pessary)

Study type: Interventional

Funder types: Other

Identifiers

NCT01242384

PECEP-RETARD 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 after an episode of threatened preterm labour.

Enrollment: 500 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Minimal age of 18 years
• Episode of threatened preterm labour

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

Sample size: 336 singleton (168 per arm) and 128 twins (64 per arm).

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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500 participants in 2 patient groups

Expectant Management

No Intervention group

Placement of cervical pessary since 23 weeks until 37 weeks

Experimental group

Treatment:

Device: Device: Silicon ring (Arabin Pessary)