Predicting the effect of maternal docosahexaenoic acid (DHA) supplementation to reduce early preterm birth in Australia and the United States using results of within country randomized controlled trials

Prostaglandins Leukot Essent Fatty Acids. 2016 Sep:112:44-9. doi: 10.1016/j.plefa.2016.08.007. Epub 2016 Aug 17.

Abstract

The DHA to Optimize Mother Infant Outcome (DOMInO) and Kansas DHA Outcomes Study (KUDOS) were randomized controlled trials that supplemented mothers with 800 and 600mg DHA/day, respectively, or a placebo during pregnancy. DOMInO was conducted in Australia and KUDOS in the United States. Both trials found an unanticipated and statistically significant reduction in early preterm birth (ePTB; i.e., birth before 34 weeks gestation). However, in each trial, the number of ePTBs were small. We used a novel Bayesian approach to estimate statistically derived low, moderate or high risk for ePTB, and to test for differences between the DHA and placebo groups. In both trials, the model predicted DHA would significantly reduce the expected proportion of deliveries in the high risk group under the trial conditions of the parent studies. Among the next 300,000 births in Australia we estimated that 1112 ePTB (95% credible interval 51-2189) could be avoided by providing DHA. And in the USA we estimated that 106,030 ePTB (95% credible interval 6400 to 175,700) could be avoided with DHA.

Trial registration: ClinicalTrials.gov NCT00266825.

Keywords: Docosahexaenoic acid; Early preterm birth; Pregnancy; Randomized controlled trials.

Publication types

  • Research Support, N.I.H., Extramural
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Australia / epidemiology
  • Bayes Theorem
  • Dietary Supplements
  • Docosahexaenoic Acids / administration & dosage*
  • Double-Blind Method
  • Female
  • Gestational Age
  • Humans
  • Multicenter Studies as Topic
  • Pregnancy
  • Premature Birth / epidemiology*
  • Premature Birth / prevention & control*
  • Randomized Controlled Trials as Topic
  • Treatment Outcome
  • United States / epidemiology

Substances

  • Docosahexaenoic Acids

Associated data

  • ANZCTR/ACTRN12605000569606
  • ClinicalTrials.gov/NCT00266825