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

Phase 4

Completed

• Conditions: Early preterm birth; Diet and Nutrition - Other diet and nutrition disorders; Reproductive Health and Childbirth - Fetal medicine and complications of pregnancy

• Registration Number: ACTRN12613001142729
• Lead Sponsor: South Australian Health and Medical Research Institute

Brief Summary

Supplementation with omega-3 fatty acids from early pregnancy (<20 weeks gestation) until 34 weeks of gestation did not result in a lower incidence of early preterm delivery or a higher incidence of interventions in post-term deliveries than control.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-10-14
• Study Completion: 2017-12-29
• Last Update Posted: 4 July 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 5544

Inclusion Criteria

A singleton or multiple pregnancy and less than 20 weeks gestation.

Able to give informed consent.

Exclusion Criteria

Women with a known fetal abnormality will be excluded.

Women who are taking dietary supplements containing LCPUFA > 150mg/day.

Women who are taking dietary supplements containing LCPUFA < / = 150mg/day and are not willing to stop.

Women with bleeding disorders where fish oil is contraindicated or are on anticoagulant therapy.

Women with a history of drug or alcohol abuse.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluate the impact of fish oil supplementation on the incidence of early preterm birth compared with placebo.[Early preterm birth defined as delivery before 34 weeks completed gestation age.]