Status:
COMPLETED
Does Progesterone Prevent Very Preterm Delivery in Twin Pregnancies?
Lead Sponsor:
Rigshospitalet, Denmark
Collaborating Sponsors:
The Danish Medical Research Council
The Danish Medical Society in Copenhagen
Conditions:
Preterm Delivery
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
The purpose of the study is to determine whether a daily dose of 200 mg progesterone administered vaginally from 20-23 to 34 weeks' gestation will reduce the rate of preterm delivery amongst twin preg...
Detailed Description
Multiple gestations account for 2% of all pregnancies, but cause more than 10% of the cases of preterm delivery. Due to increasing maternal age and use of assisted reproduction the number of multiple ...
Eligibility Criteria
Inclusion
- Twin pregnancy
- Informed consent
- 18-23 weeks' gestation
- Participants must be fluent in the language spoken in the respective centres
Exclusion
- Age \< 18 years
- Known allergy to progesterone or peanuts
- Active thromboembolic disorders or a history of hormone-associated thromboembolic disorders
- Rupture of membranes at the time of inclusion
- Monoamniotic twins
- Pregnancies treated for or with signs of twin-to-twin transfusion syndrome at inclusion
- Multiple pregnancies reduced to twin pregnancies
- Known significant structural or chromosomal fetal abnormality
- Chorionicity not assessed before 15 weeks
- Known or suspected malignancy in genitals or breasts
- Known liver disease
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
677 Patients enrolled
Trial Details
Trial ID
NCT00329914
Start Date
June 1 2006
End Date
September 1 2010
Last Update
July 25 2011
Active Locations (17)
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1
Graz University Hospital
Graz, Austria, 8036
2
Innsbruck University Hospital
Innsbruck, Austria, 6020
3
Klagenfurt Hospital
Klagenfurt, Austria, 9020
4
Vienna University Hospital
Vienna, Austria, 1090