Prevention of Preterm Birth Using Cervical Pessary in Pregnant Women With Short Cervix in Twins
Phase 4
Completed
- Conditions
- Preterm Birth
- Interventions
- Device: Silicon ring (Arabin Cervical Pessary)
- Registration Number
- NCT01242410
- Lead Sponsor
- Maternal-Infantil Vall d´Hebron Hospital
- Brief Summary
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.
- Detailed Description
This trial includes pregnant women with twins undergoing routine ultrasound examination at 18.0 to 22.6 weeks of gestation.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 137
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placement of cervical pessary since 23 weeks until 37 weeks Silicon ring (Arabin Cervical Pessary) -
- Primary Outcome Measures
Name Time Method Spontaneous delivery before 34 completed weeks Each 6 months
- Secondary Outcome Measures
Name Time Method Birth weight Each 6 months Fetal-Neonatal Death Each 6 months Neonatal morbidity Each 6 months Preterm birth before 37 weeks or 28 weeks Each 6 months Rupture of membranes before 34 weeks Each 6 months Hospitalisation for threatened preterm labour Each 6 months Maternal adverse effects Each 6 months
Trial Locations
- Locations (1)
Hospital Vall d'Herbron
🇪🇸Barcelona, Spain