Status:
COMPLETED
Prevention of Preterm Birth Using Cervical Pessary in Pregnant Women With Short Cervix
Lead Sponsor:
Maternal-Infantil Vall d´Hebron Hospital
Collaborating Sponsors:
Hospital Universitario de Canarias
Hospital Son Llatzer
Conditions:
Preterm Birth
Eligibility:
FEMALE
18-45 years
Phase:
NA
Brief Summary
Placement of a vaginal pessary reduces significantly the rate of spontaneous preterm birth in pregnant women with short cervical length at 18-22 weeks scan.
Detailed Description
This trial includes pregnant women undergoing routine ultrasound examination at 18.0 to 22.6 weeks of gestation.
Eligibility Criteria
Inclusion
- Singleton pregnancy
- Minimal age of 18 years
Exclusion
- Major fetal abnormalities (requiring surgery or leading to infant death or severe handicap)
- SROM at the time of randomization
- Cervical cerclage in situ
- Active vaginal bleeding
- Previous cone biopsy or cerclage
- Major uterine structural anomalies
- Placenta previa
Key Trial Info
Start Date :
June 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2014
Estimated Enrollment :
385 Patients enrolled
Trial Details
Trial ID
NCT00706264
Start Date
June 1 2007
End Date
July 1 2014
Last Update
March 17 2021
Active Locations (6)
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1
Hospital Materno-Infantil de Canarias
Las Palmas de Gran Canaria, Gran Canaria, Spain, 35016
2
Hospital Son Llàtzer
Palma de Mallorca, Mallorca, Spain, 07198
3
Hospital de Reus
Reus, Tarragona, Spain
4
Hospital Vall d´Hebron
Barcelona, Spain, 08035