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

• Status: Completed
• Trial end date: 2008-03-01
• Target enrollment: 0
• Participant gender: Female

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 received 17P in this trial still had a high rate of preterm birth. Several reports have shown that dietary supplementation of fish oil, which is rich in Omega-3 fatty acids, reduces the risk of preterm birth. This trial tests whether adding the Omega-3 supplement to 17P therapy has the potential for further reducing the risk of preterm birth in women who have previously had a spontaneous preterm delivery. The trial will compare Omega-3 fatty acid with placebo in women receiving 17P therapy. The hypothesis being tested is: "Among women at high risk for preterm birth receiving weekly injections of 17P, the addition of Omega-3 nutritional supplement will further reduce the rate of preterm birth."

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: The George Washington University Biostatistics Center
• Collaborator: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Treatments: 11-hydroxyprogesterone; 17 alpha-Hydroxyprogesterone Caproate; 17-alpha-hydroxy-progesterone caproate; Progesterone

Criteria

Inclusion Criteria:

• Documented history of previous singleton spontaneous birth

• Singleton pregnancy

• Gestational age at randomization between 16 and 22 weeks

Exclusion Criteria:

• 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