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

Maternal-Infantil Vall d´Hebron Hospital137 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

137

Conditions

Preterm Birth

Interventions

Silicon ring (Arabin Cervical Pessary)DEVICE

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

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 Years

Medical Language ↔ Plain English

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

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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