Prevention of Preterm Birth Using Cervical Pessary in Pregnant Women After Threatened Preterm Labor(PECEP-RETARD)
Phase 4
Completed
- Conditions
- Preterm Birth
- Registration Number
- NCT01242384
- 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 short cervical length after an episode of threatened preterm labour.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 500
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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- 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 Preterm birth before 37 weeks or 28 weeks Each 6 months Fetal-Neonatal Death Each 6 months Neonatal morbidity Each 6 months Rupture of membranes before 34 weeks Each 6 months Maternal adverse effects Each 6 months Hospitalisation for threatened preterm labour Each 6 months
Trial Locations
- Locations (1)
Hospital Vall d'Herbron
🇪🇸Barcelona, Spain