Status:
COMPLETED
Omega-3 Fatty Acid Supplementation to Prevent Preterm Birth in High Risk Pregnancies
Lead Sponsor:
The George Washington University Biostatistics Center
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Preterm Birth
Eligibility:
FEMALE
Phase:
PHASE3
Brief Summary
A recently completed trial of weekly injections of 17 alpha hydroxyprogesterone caproate (17P) found significant effectiveness for 17P in preventing recurrent preterm birth. However, the group who rec...
Detailed Description
Preterm birth is the leading cause of perinatal mortality and morbidity. In a recently completed trial of weekly injections of 17 alpha hydroxyprogesterone caproate (17P), the National Institute of Ch...
Eligibility Criteria
Inclusion
- Documented history of previous singleton spontaneous birth
- Singleton pregnancy
- Gestational age at randomization between 16 and 22 weeks
Exclusion
- Major fetal anomaly or demise
- Regular intake of fish oil supplements
- Daily use of nonsteroidal anti-inflammatory agents
- Allergy to fish or fish products
- Gluten intolerant
- Heparin use or known thrombophilia
- Hemophilia
- Planned termination
- Current hypertension or current use of antihypertensive medications
- Type D, F or R diabetes
- Maternal medical complications
- Current or planned cerclage
- Illicit drug or alcohol abuse during current pregnancy
- Delivery at a non-Network hospital
- Participation in another pregnancy intervention study
- Participation in this trial in a previous pregnancy
Key Trial Info
Start Date :
February 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2008
Estimated Enrollment :
800 Patients enrolled
Trial Details
Trial ID
NCT00135902
Start Date
February 1 2005
End Date
March 1 2008
Last Update
July 12 2019
Active Locations (12)
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1
University of Alabama - Birmingham
Birmingham, Alabama, United States
2
Northwestern University
Chicago, Illinois, United States
3
Wayne State University
Detroit, Michigan, United States
4
Columbia University
New York, New York, United States