Data

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 gestation
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Related Study

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

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 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.

Inclusion Criteria

  • A singleton or multiple pregnancy and less than 20 weeks gestation. Able to give informed consent.

Study Type

  • Interventional

Ethics Approval

Study Protocol: Available
Data Dictionary: Not Available

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.