Omega-3 Fatty Acid Supplementation to Prevent Preterm Birth in High Risk Pregnancies

PHASE3CompletedINTERVENTIONAL
Enrollment

800

Participants

Timeline

Start Date

February 28, 2005

Primary Completion Date

March 31, 2007

Study Completion Date

March 31, 2008

Conditions
Preterm Birth
Interventions
DRUG

17 alpha-Hydroxyprogesterone Caproate and Omega-3 supplement

Participants receive a weekly progesterone injection (17 alpha hydroxyprogesterone caproate) up to 37 weeks gestation and take daily Omega-3 supplements.

DRUG

17 alpha-hydroxy progesterone caproate and Placebo supplement

Participants receive a weekly progesterone injection (17P) up to 37 weeks gestation and take daily placebo supplements

Trial Locations (12)

Unknown

University of Alabama - Birmingham, Birmingham

Northwestern University, Chicago

Wayne State University, Detroit

Columbia University, New York

University of North Carolina - Chapel Hill, Chapel Hill

Wake Forest University School of Medicine, Winston-Salem

Case Western University, Cleveland

Ohio State University, Columbus

Drexel University, Philadelphia

University of Pittsburgh Magee Womens Hospital, Pittsburgh

Brown University, Providence

University of Utah Medical Center, Salt Lake City

All Listed Sponsors
collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

lead

The George Washington University Biostatistics Center

OTHER

NCT00135902 - Omega-3 Fatty Acid Supplementation to Prevent Preterm Birth in High Risk Pregnancies | Biotech Hunter | Biotech Hunter