Status:
COMPLETED
Progesterone for Prevention of Preterm Birth in Women With Short Cervix: Randomized Controlled Trial
Lead Sponsor:
King's College Hospital NHS Trust
Conditions:
Preterm Birth
Pregnancy Trimester, Second
Eligibility:
FEMALE
Phase:
PHASE3
Brief Summary
The aim of our study is to evaluate the effect of use of prophylactic vaginal progesterone on the incidence of severe preterm delivery, defined as delivery before 33+6 weeks in women with a short cerv...
Detailed Description
BACKGROUND The results of randomized studies have shown that the prophylactic use of progesterone in women who previously delivered prematurely reduces the risk of recurrence. Asymptomatic women found...
Eligibility Criteria
Inclusion
- All women with singleton or twin pregnancies attending for routine ultrasound examination at 20-25 weeks of gestation with a short cervical length (\<15 mm).
Exclusion
- Women with major fetal abnormalities,
- Painful regular uterine contractions, or history of ruptured membranes or cervical cerclage in-situ were excluded from screening.
Key Trial Info
Start Date :
September 1 2003
Trial Type :
INTERVENTIONAL
End Date :
November 1 2006
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT00422526
Start Date
September 1 2003
End Date
November 1 2006
Last Update
January 17 2007
Active Locations (8)
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1
Hospital do Servidor Publico Estadual-FMO
São Paulo, São Paulo, Brazil
2
Hospital Clinico Universidad de Chile
Santiago, Santiago Metropolitan, Chile
3
University Hospital
Larissa, Larissa, Greece
4
University Hospital of Lewisham
London, London, United Kingdom, SE13 6LH