SEARCHRCTobstetrics and gynecology, nutrition

RCT·obstetrics and gynecology, nutrition, clinical nutrition, micronutrients, clinical trial·PMC10533701

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

BMJ Open · 9 authors, 7 centres

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TL;DR

This exploratory analysis of a randomised trial identified maternal factors that predicted compliance with omega-3 supplementation during pregnancy and estimated the treatment effect among compliers. It found supplementation reduced preterm birth risk in compliant women, consistent with the original trial's overall findings.

Full summary

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Compliance was assessed at 28 weeks. Predictors of compliance were identified using logistic regression, and treatment effects among compliers were estimated using the complier average causal effect (CACE) method. The authors conclude that non-compliance did not majorly explain the trial's overall outcomes, as results in compliers were similar to the original intention-to-treat analysis.

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RCT

SPECIALTY

obstetrics and gynecology

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AI pipeline

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ORIGINAL PAPER

PMC10533701

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

BMJ Open

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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.

CITATION EXPORT

Thomas R Sullivan, Lisa N Yelland, Robert A Gibson et al.. 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. BMJ Open. (2023). https://doi.org/10.1136/bmjopen-2023-076507

AUTHORS

9 · 7 CENTRES

Thomas R Sullivan, Lisa N Yelland, Robert A Gibson, Sagar K Thakkar, Fang Huang, Karen P Best, Surabhi Devaraj, Irma Silva Zolezzi, Maria Makrides

1SAHMRI Women & Kids, South Australian Health and Medical Research Institute Limited, Adelaide, South Australia, Australia
2School of Public Health, The University of Adelaide, Adelaide, South Australia, Australia
3School of Agriculture, Food and Wine, The University of Adelaide, Adelaide, South Australia, Australia
4Nestlé Product Technology Center—Nutrition, Societe des Produits Nestle SA, Vevey, Vaud, Switzerland
5Nestlé Research, Societe des Produits Nestle SA, Beijing, China
6School of Medicine, The University of Adelaide, Adelaide, South Australia, Australia
7Nestlé Research, Societe des Produits Nestle SA, Singapore