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. 2018 Nov 15;2018(11):CD003402. doi: 10.1002/14651858.CD003402.pub3

Haghiac 2015.

Methods RCT: NCT00957476
Participants 72 women randomised
Inclusion criteria: overweight/obese pregnant women (BMI ≥ 25 at first antenatal visit); singleton pregnancy and GA between 8 weeks and 16 weeks
Exclusion criteria: known fetal anomaly, regular intake of fish oil supplements (> 500 mg per week in the previous 4 weeks), daily use of NSAIDs; pre‐existing metabolic disorder such as hypertension, diabetes or hyperthyroidism; allergy to fish or fish products; gluten intolerance; women who are vegetarians and do not eat any fish; planned termination of pregnancy or birth at another hospital; known HIV‐positive, illicit drug or alcohol use during current pregnancy
Setting: MetroHealth Medical Center, Ohio, USA (participants recruited September 2009 to August 2011)
Interventions SUPPLEMENTATION: DHA + EPA versus placebo
Group 1: DHA plus EPA (total 2 g/day): 800 mg DHA (22:6n‐3) and 1200 mg EPA (20:5n‐3): 4 capsules (2 x twice a day). Total number randomised: n = 36 (25)
Group 2: placebo (2 capsules twice a day); contains wheat germ oil. Total number randomised: n = 36 (25)
Timing of supplementation: weeks 10‐16 to term
DHA + EPA dose/day: high: 800 mg DHA + 1200 mg EPA
Outcomes Women/birth: length of gestation; maternal plasma omega‐3 and omega‐6 concentrations; CRP; TLR4, IL6, IL8 (in adipose and placental tissue); glucose concentrations; insulin sensitivity (narrative report only); adiponectin; leptin; spontaneous abortions; stillbirth; gestational diabetes; placental gene expression; placental triglycerides
Babies/infants/children: birthweight; neonatal lean mass; fat mass; body fat; pea pod lean mass; pea pod fat mass; pea pod body fat
Notes Notes relating to intervention: adherence run‐in: consenting eligible women were given 1 week’s supply of placebo capsules; they were not allowed to participate in the trial if they did not return or if they had taken < 50% of the placebo capsules.
Funding: NIH RHD057236. Emiment supplied the study supplements.
Declarations of interest: "The authors declared that they have no conflicts of interest".
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Computerised random number generation
Allocation concealment (selection bias) Low risk Quote: "Randomization and treatment assignment were carried out by the research coordinators"
Probably done
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Quote: "Study group assignment was not known by study participants, their health care providers, or the research staff"
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Not reported but probably done
Incomplete outcome data (attrition bias) 
 All outcomes High risk 21/72 (29%) attrition:
Omega‐3 group, lost 10:
  • 7 missed second visit

  • 1 spontaneous abortion

  • 1 unable to contact

  • 1 moved away


Control group, lost 11:
  • 7 missed second visit

  • 1 spontaneous abortion

  • 2 unable to contact

  • 1 moved away (slightly different numbers reported in different parts of the papers)

Selective reporting (reporting bias) Unclear risk Few maternal, birth and neonatal outcomes reported
Other bias Unclear risk Baseline characteristics were similar except for higher average weight (but not BMI) in the omega‐3 group.