Makrides 2013 (ORIP).

Trial name or title	Omega‐3 fats to reduce the incidence of prematurity: the ORIP trial
Methods	RCT: ACTRN12613001142729
Participants	Recruitment target: 5540 women. Inclusion criteria: < 20 weeks' gestation (singleton or multiple pregnancy). Exclusion criteria: known fetal abnormality; taking dietary supplements containing LCPUFA 150mg/day; taking dietary supplements containing LCPUFA 150 mg/day and not willing to stop; bleeding disorders where fish oil is contraindicated or on anticoagulant therapy; and history of drug or alcohol abuse. Setting: South Australia, Victoria and Queensland, Australia.
Interventions	Intervention group 3 capsules of fish oil containing a total dose of approximately 800 mg of DHA daily from enrolment (12 weeks ‐ 20 weeks' gestation) until 34 weeks of gestation or birth (whichever occurs first) Control group 3 placebo vegetable oil capsules with a trace of DHA to aid masking.
Outcomes	Primary outcome: early preterm birth (< 34 weeks). Other outcomes: post‐term induction; post‐term pre labour caesarean birth; preterm birth (< 37 weeks); safety and tolerability of DHA supplementation; low birthweight (< 2500 g); small‐for‐gestational age (< 10th centile for corresponding GA and sex); neonatal complications (up to 28 days post birth); admission to NICU.
Starting date	October 2013
Contact information	Prof Maria Makrides, SAHMRI. E‐mail: maria.makrides@sahmri.com
Notes	Funding and collaborators: NHMRC; SAHMRI. Recruitment ended 27 April 2017.