National Institute of Child Health and Human Development
Maternal Fetal Medicine Units Network

A Randomized Trial of Omega-3 Fatty Acid Supplementation
to Prevent Preterm Birth in Pregnancies at High Risk

Objective

To determine whether Omega-3, in conjunction with 17P injections, reduces the risk of preterm birth in women at high risk for spontaneous preterm delivery.

Project Status

Recruiting has been completed.

Clinical Centers

Magee WomenĘs, Alabama, Wayne State, Wake Forest, Ohio State, Texas-Dallas, Utah, Drexel, Brown, Columbia, Case Western Reserve, Texas-Houston, UNC, Northwestern

Type

Double masked randomized clinical trial

Major Eligibility Criteria

• Gestational age 16⁰ -21⁶ weeks
• Singleton pregnancy
• Previous singleton spontaneous preterm delivery
• Informed consent

Groups

• Active : 250 mg 17P weekly + 2000 mg Omega-3 daily
• Placebo : 250 mg 17P weekly + 2000 mg mineral oil daily
• (17P = 17 a - hydroprogesterone caproate)

Sample Size

Trial goal = 800 (400/group)

Management Protocols

• Open label medication
• Weekly injection of 250 mg of 17P
• To be administered from randomization to delivery or 366 weeks, whichever comes first
• Coded medication
• Daily dose of 4 soft gel capsules
• To be taken from randomization to delivery or 366 weeks, whichever comes first

Outcome Measures

• Primary:
• Preterm delivery <370 weeks of gestation
• Secondary
• Composite neonatal outcome

Timetable

• Enrollment: Sept 2004 - March 2008
• Data Collection: Sept 2004 - Jan 2009
• Closeout/final analysis: Feb 2009 - August 2009