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

This OMEGA-3 dataset (sas version) contains information across the data collection instruments for 852 study participants
Study Description
This study is a randomized placebo-control trial to test the hypothesis that among patients with at least one prior spontaneous preterm delivery, receiving weekly 17-hydroxyprogesterone caproate with the addition of an omega-3 supplement would further reduce the rate of recurrent preterm birth. Patients were assigned to either a daily 1200mg omega-3 supplement or matching placebo from 16–22 through 36 weeks of gestation. All participants received 250mg weekly intramuscular 17-hydroxyprogesterone caproate. A total of 434 patients were randomly assigned to the omega-3 supplement arm and 418 patients to the placebo arm. Daily supplementation with 1,200 mg of EPA and 800 mg of DHA did not reduce the rate of repeat preterm birth before 37 weeks, before 35 weeks, or before 32 weeks among high-risk patients receiving 17-hydroxyprogesterone caproate. Women with a singleton pregnancy between 16 and 21 weeks, 6 days gestation who had a history of a prior preterm delivery between 20 weeks, 0 days and 36 weeks, 6 days gestation after spontaneous preterm labor or premature rupture of the membranes.