Omega-3 fats to reduce the incidence of prematurity: the ORIP trial

Early preterm birth (EPTB) is the major cause of perinatal mortality, serious neonatal morbidity and moderate to severe childhood disability in developed countries. Currently, effective broadly applicable primary prevention strategies to reduce the risk of EPTB in the general population are lacking. This randomised controlled trial will determine whether n-3 LCPUFA supplementation from mid-pregnancy (before 20 weeks gestation) to 34 weeks gestation reduces the risk of EPTB. The study is a double blind, randomised controlled multi-centre trial. The primary outcome is the Incidence of early preterm birth (EPTB) defined as delivery before 34 completed weeks gestation. Secondary outcomes include Incidence of post-term induction or post-term pre-labour caesarean section, other outcomes known to be directly affected by EPTB, and the safety and tolerability of DHA supplementation. Eligible women will be randomly allocated to either intervention (~800 mg DHA) or control groups.. Women will receive intervention from trial entry (<20 weeks) to 34 weeks gestation or birth, whichever comes first. Women will be followed up to discharge after birth. The study will be conducted over a 5 year period 2013 to 2017. A total of 5540 pregnant women will be recruited to take part in the trial.