Please use this identifier to cite or link to this item:
https://hdl.handle.net/2440/139739
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dc.contributor.author | Sullivan, T.R. | - |
dc.contributor.author | Yelland, L.N. | - |
dc.contributor.author | Gibson, R.A. | - |
dc.contributor.author | Thakkar, S.K. | - |
dc.contributor.author | Huang, F. | - |
dc.contributor.author | Best, K.P. | - |
dc.contributor.author | Devaraj, S. | - |
dc.contributor.author | Zolezzi, I.S. | - |
dc.contributor.author | Makrides, M. | - |
dc.date.issued | 2023 | - |
dc.identifier.citation | BMJ Open, 2023; 13(9):e076507-1-e076507-8 | - |
dc.identifier.issn | 2044-6055 | - |
dc.identifier.issn | 2044-6055 | - |
dc.identifier.uri | https://hdl.handle.net/2440/139739 | - |
dc.description.abstract | Background: 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.statementofresponsibility | Thomas R Sullivan, Lisa N Yelland, Robert A Gibson, Sagar K Thakkar, Fang Huang, Karen P Best, Surabhi Devaraj, Irma Silva Zolezzi, Maria Makrides | - |
dc.language.iso | en | - |
dc.publisher | BMJ Journals | - |
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.uri | http://dx.doi.org/10.1136/bmjopen-2023-076507 | - |
dc.subject | Humans | - |
dc.subject | Premature Birth | - |
dc.subject | Fatty Acids, Omega-3 | - |
dc.subject | Fatty Acids | - |
dc.subject | Capsules | - |
dc.subject | Pregnancy | - |
dc.subject | Dietary Supplements | - |
dc.subject | Infant, Newborn | - |
dc.subject | Australia | - |
dc.subject | Female | - |
dc.subject.mesh | Humans | - |
dc.subject.mesh | Premature Birth | - |
dc.subject.mesh | Fatty Acids, Omega-3 | - |
dc.subject.mesh | Fatty Acids | - |
dc.subject.mesh | Capsules | - |
dc.subject.mesh | Pregnancy | - |
dc.subject.mesh | Dietary Supplements | - |
dc.subject.mesh | Infant, Newborn | - |
dc.subject.mesh | Australia | - |
dc.subject.mesh | Female | - |
dc.title | 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 | - |
dc.type | Journal article | - |
dc.identifier.doi | 10.1136/bmjopen-2023-076507 | - |
dc.relation.grant | http://purl.org/au-research/grants/nhmrc/1135155 | - |
pubs.publication-status | Published | - |
dc.identifier.orcid | Yelland, L.N. [0000-0003-3803-8728] | - |
dc.identifier.orcid | Gibson, R.A. [0000-0002-8750-525X] | - |
dc.identifier.orcid | Best, K.P. [0000-0002-7653-5074] | - |
dc.identifier.orcid | Makrides, M. [0000-0003-3832-541X] | - |
Appears in Collections: | Agriculture, Food and Wine publications Medicine publications Public Health publications |
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