Omega-3 fats to reduce the incidence of prematurity - The ORIP Trial
South Australian Health and Medical Research Institute (SAHMRI)Dataset description
Omega-3 fats to reduce the incidence of prematurity in healthy women with a singleton or multiple pregnancy less than 20 weeks gestationIdentifiers
Source Study
Trial name (public)
Omega-3 fats to reduce the incidence of prematurity: the ORIP trialTrial acronym
The ORIP trial
Trial ID
ACTRN12613001142729
Purpose
Prevention
Phase
Phase 4
Funding
Government body,National Health and Medical Research Council
Scientific enquiries
Prof Maria Makrides
Brief Summary
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 .... Read more
Key Inclusion Criteria
A singleton or multiple pregnancy and less than 20 weeks gestation. Able to give informed consent.
Key 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.
Can healthy volunteers participate?
Yes
Population
Sample Size 5544
Min. age 0 No limit
Max. age 0 No limit
Sex Females
Condition category Early preterm birth
Condition code Diet and Nutrition , Reproductive Health and Childbirth
Intervention
Intervention code Prevention
3 capsules of fish oil containing a total dose of approximately 800 mg of DHA will be administered orally per day until 34 weeks gestation or birth (whichever occurs first). Women will be asked to return unused supplements at the end of the 34 weeks gestation when a spot blood sample is taken. The proportion of capsules returned will serve as a measure of adherence. DHA concentration at the end of intervention will be used as an independent biomarker of adherence.
Comparison
Control group Placebo
Vegetable oils with a trace of DHA to aid masking
Outcomes
Outcome: Evaluate the impact of fish oil supplementation on the incidence of early preterm birth compared with placebo.Timepoint: Early preterm birth defined as delivery before 34 weeks completed gestation age.
Will individual participant data (IPD) for this trial be available?
yes
What data in particular will be shared?
Yes. De-identified, individual participant data (IPD) that underlie the results reported in the primary paper (text, tables, figures and appendices) will be available. Dataset(s) will be limited to those participants and variables that are necessary for completion of the approved research proposal.
When will data be available?
Data requests will be accepted beginning 3 months and ending 5 years after publication of trial results.
Available to whom?
Data will be available to researchers who provide a methodologically sound research proposal following review and approval by the trial steering committee and completion of a signed data access agreement.
Available for what types of analyses?
Data may be shared with researchers who provide a methodologically sound research proposal following review and approval by the trial steering committee and completion of a signed data access agreement.