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

Maternal-Infantil Vall d´Hebron Hospital500 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

500

Conditions

Preterm Birth

Interventions

Device: Silicon ring (Arabin Pessary)DEVICE

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

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 Years

Medical Language ↔ Plain English

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).

Locations (1)

Hospital Vall d'Herbron

Barcelona, Barcelona, Spain

Outcomes

Primary Outcomes

Spontaneous delivery before 34 completed weeks

Time frame: Each 6 months

Secondary Outcomes

Birth weight

Time frame: Each 6 months

Fetal-Neonatal Death

Time frame: Each 6 months

Neonatal morbidity

Time frame: Each 6 months

Maternal adverse effects

Time frame: Each 6 months

Preterm birth before 37 weeks or 28 weeks

Time frame: Each 6 months

Rupture of membranes before 34 weeks

Time frame: Each 6 months

Hospitalisation for threatened preterm labour

Time frame: Each 6 months

Data from ClinicalTrials.gov

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