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

The George Washington University Biostatistics Center

Status and phase: Completed; Phase 3

Conditions: Preterm Birth

Treatments: Drug: 17 alpha-Hydroxyprogesterone Caproate and Omega-3 supplement; Drug: 17 alpha-hydroxy progesterone caproate and Placebo supplement

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00135902

U10HD040544 (U.S. NIH Grant/Contract)

U10HD027860 (U.S. NIH Grant/Contract)

U10HD040545 (U.S. NIH Grant/Contract)

U10HD036801 (U.S. NIH Grant/Contract)

U10HD034136 (U.S. NIH Grant/Contract)

U10HD040500 (U.S. NIH Grant/Contract)

U10HD027915 (U.S. NIH Grant/Contract)

U10HD027917 (U.S. NIH Grant/Contract)

U10HD027869 (U.S. NIH Grant/Contract)

U10HD034208 (U.S. NIH Grant/Contract)

HD36801-Omega-3

U10HD040560 (U.S. NIH Grant/Contract)

U10HD040512 (U.S. NIH Grant/Contract)

U10HD040485 (U.S. NIH Grant/Contract)

U10HD021410 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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."

Full 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 Child Health and Human Development (NICHD) Maternal Fetal Medicine Units (MFMU) Network found the treatments significantly beneficial in the prevention of recurrent preterm birth. Other studies have shown that fish oil supplementation can reduce the risk for preterm birth. The purpose of this study is to determine whether Omega-3, a polyunsaturated fatty acid nutritional supplement, in addition to injections of 17P, further decreases the rate of preterm birth in women at risk.

This study is a randomized, double-masked clinical trial with two study arms: a daily supplement of Omega-3 capsules containing 800 mg of DHA and 1200 mg of EPA or a daily supplement of a matching placebo. All patients will also receive weekly injections of 17P. Eight hundred pregnant women with a history of previous preterm delivery will be recruited for this study. After successfully completing a compliance run-in, which can begin as early as 15 weeks gestation, patients will be randomized and begin treatment between 16 and 22 weeks gestation. They will remain on study drug until 36 week and 6 days or delivery, whichever occurs first. Blood will be drawn at randomization and at a monthly visit falling between 25-29 weeks of gestation to test for compliance, to analyze genetic polymorphisms and to determine whether Omega-3 affects the production of inflammatory cytokines.

Enrollment: 800 patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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800 participants in 2 patient groups, including a placebo group

17P plus Omega-3 Supplement

Active Comparator group

Description:

Weekly 17 alpa hydroxyprogesterone caproate (17p) injections plus Omega 3 supplements, 4 capsules per day for up to 5 weeks. Each capsule contained 200 mg of docosahexaenoic acid (DHA) and 300 mg of eicosapentaenoic acid (EPA).

Treatment:

Drug: 17 alpha-Hydroxyprogesterone Caproate and Omega-3 supplement

17P plus Placebo Supplement

Placebo Comparator group

Description:

Weekly 17 alpa hydroxyprogesterone caproate (17p) injections plus placebo capsules, 4 capsules per day for up to 5 weeks

Treatment:

Drug: 17 alpha-hydroxy progesterone caproate and Placebo supplement