Status:
COMPLETED
Prevention of Preterm Birth Using Cervical Pessary in Pregnant Women After Threatened Preterm Labor(PECEP-RETARD)
Lead Sponsor:
Maternal-Infantil Vall d´Hebron Hospital
Conditions:
Preterm Birth
Eligibility:
FEMALE
18-45 years
Phase:
PHASE4
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.
Eligibility Criteria
Inclusion
- Minimal age of 18 years
- Episode of threatened preterm labour
Exclusion
- 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).
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2014
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT01242384
Start Date
June 1 2008
End Date
July 1 2014
Last Update
September 20 2016
Active Locations (1)
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1
Hospital Vall d'Herbron
Barcelona, Barcelona, Spain, 08036