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

• Delivery less than 37 completed weeks gestation including any miscarriages occurring after randomization
  

• MATERNAL: Delivery less than 35 weeks
  
• Delivery less than 32 weeks
  
• Spontaneous preterm delivery
  
• Indicated preterm delivery
  
• Tocolytic therapy
  
• Time from randomization to delivery
  
• Delivery on or after 41 weeks of gestation
  
• Occurrence of gestational hypertension or preeclampsia
  
• Maternal hospital days
  
• Fatty acid constituents in maternal plasma samples, before and after supplementation
  
• Postpartum hemorrhage
  
• FETAL AND NEONATAL: Fetal and neonatal death
  
• Gestational age at delivery
  
• Small for gestational age
  
• Birth weight
  
• Apgar score at 1 and 5 minutes
  
• Number of days of neonatal respiratory therapy
  
• Admission to NICU and total number of days in hospital
  
• Intraventricular hemorrhage
  
• Retinopathy of prematurity
  
• Necrotizing enterocolitis
  
• Deep infection
  
• Periventricular leukomalacia
  
• Bronchopulmonary dysplasia
  
• Respiratory distress syndrome
  
• Composite neonatal outcome
  

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.