Predictors of compliance with higher dose omega-3 fatty acid supplementation during pregnancy and implications for the risk of prematurity: exploratory analysis of the ORIP randomised trial

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dc.contributor.authorSullivan, T.R.
dc.contributor.authorYelland, L.N.
dc.contributor.authorGibson, R.A.
dc.contributor.authorThakkar, S.K.
dc.contributor.authorHuang, F.
dc.contributor.authorBest, K.P.
dc.contributor.authorDevaraj, S.
dc.contributor.authorZolezzi, I.S.
dc.contributor.authorMakrides, M.
dc.date.issued2023
dc.description.abstractBackground: Intention-to-treat analyses of the Omega‐3 to Reduce the Incidence of Prematurity (ORIP) trial found that omega-3 (n-3) fatty acid supplementation reduces the risk of prematurity in the subgroup of women with a singleton pregnancy and low n-3 status early in pregnancy, but not overall. However, results may have been influenced by less-than-optimal compliance. Objectives: To identify predictors of compliance with n-3 supplementation and determine treatment effects among compliers. Design: Exploratory analyses of a multicentre-blinded randomised trial. Setting: 6 tertiary care centres in Australia. Participants: 5328 singleton pregnancies. Interventions: Daily capsules containing 900 mg n-3 long-chain polyunsaturated fatty acids or vegetable oil, consumed from before 20 weeks gestation until 34 weeks gestation. Outcome measures: Early preterm (<34 weeks gestation) and preterm birth (<37 weeks gestation). Women were considered compliant if they reported missing less than a third of their allocated capsules in the previous week during a mid-pregnancy appointment. Results: Among 2654 singleton pregnancies in the n-3 intervention group, 1727 (65%) were deemed compliant with supplementation. Maternal characteristics associated with compliance included age, years of full-time education, consuming alcohol but not smoking in the 3 months leading up to pregnancy, fewer previous births and taking dietary supplements at enrolment. Based on complier average causal effects, n-3 supplementation reduced the risk of preterm birth in compliers (relative risk=0.76; 95% CI 0.60 to 0.97), but not early preterm birth (relative risk=0.80; 95% CI 0.44 to 1.46). Consistent with intention-to-treat analyses, the lack of an overall effect on early preterm birth in compliers appeared to be due to beneficial effects in women with low n-3 status at enrolment but not women with replete status. Conclusions: Results in compliers were similar to those from intention-to-treat analyses, suggesting that non-compliance was not a major factor in explaining outcomes from the ORIP trial. Trial registration number: ACTRN12613001142729.
dc.description.statementofresponsibilityThomas R Sullivan, Lisa N Yelland, Robert A Gibson, Sagar K Thakkar, Fang Huang, Karen P Best, Surabhi Devaraj, Irma Silva Zolezzi, Maria Makrides
dc.identifier.citationBMJ Open, 2023; 13(9):e076507-1-e076507-8
dc.identifier.doi10.1136/bmjopen-2023-076507
dc.identifier.issn2044-6055
dc.identifier.issn2044-6055
dc.identifier.orcidSullivan, T.R. [0000-0002-6930-5406]
dc.identifier.orcidYelland, L.N. [0000-0003-3803-8728]
dc.identifier.orcidGibson, R.A. [0000-0002-8750-525X]
dc.identifier.orcidBest, K.P. [0000-0002-7653-5074]
dc.identifier.orcidMakrides, M. [0000-0003-3832-541X]
dc.identifier.urihttps://hdl.handle.net/2440/139739
dc.language.isoen
dc.publisherBMJ Journals
dc.relation.granthttp://purl.org/au-research/grants/nhmrc/1135155
dc.rights© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
dc.source.urihttps://doi.org/10.1136/bmjopen-2023-076507
dc.subjectHumans
dc.subjectPremature Birth
dc.subjectFatty Acids, Omega-3
dc.subjectFatty Acids
dc.subjectCapsules
dc.subjectPregnancy
dc.subjectDietary Supplements
dc.subjectInfant, Newborn
dc.subjectAustralia
dc.subjectFemale
dc.subject.meshHumans
dc.subject.meshPremature Birth
dc.subject.meshFatty Acids, Omega-3
dc.subject.meshFatty Acids
dc.subject.meshCapsules
dc.subject.meshPregnancy
dc.subject.meshDietary Supplements
dc.subject.meshInfant, Newborn
dc.subject.meshAustralia
dc.subject.meshFemale
dc.titlePredictors of compliance with higher dose omega-3 fatty acid supplementation during pregnancy and implications for the risk of prematurity: exploratory analysis of the ORIP randomised trial
dc.typeJournal article
pubs.publication-statusPublished

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