A randomised double blind placebo controlled trial of fish oil in high risk pregnancy

Br J Obstet Gynaecol. 1995 Feb;102(2):95-100. doi: 10.1111/j.1471-0528.1995.tb09059.x.


Objective: To determine whether n-3 fatty acid (EPA/DCHA) prophylaxis is beneficial in high risk pregnancies.

Design: A randomised, double blind, placebo controlled trial.

Setting: Antenatal clinic of St James's University Hospital, Leeds.

Subjects: Two hundred and thirty-three pregnant women at high risk of developing proteinuric or nonproteinuric pregnancy induced hypertension or asymmetrical intrauterine growth retardation.

Intervention: Active treatment was 2.7 g of MaxEpa daily (1.62 g of eicosapentaenoic acid and 1.08 g of docosahexaenoic acid). Placebo were matching air-filled capsules.

Main outcome measures: Occurrence of proteinuric, nonproteinuric pregnancy induced hypertension or birthweight < 3rd centile.

Results: There was no difference in an intention to treat analysis between the placebo and active treatment groups for occurrence of proteinuric pregnancy induced hypertension (relative risk (RR) = 0.88; 95% CI 0.47-1.66), nonproteinuric pregnancy induced hypertension (RR = 0.89; 95% CI 0.48-1.64), birthweight < 3rd centile (RR = 0.89; 95% CI 0.48-1.64), or the duration of pregnancy (difference of mean durations = 0.1 days; 95% CI -4.8 to 4.9 days). Analyses stratified by use of tobacco, and analyses excluding known major protocol violators gave essentially identical results.

Conclusion: There is no evidence from this study for any useful effect of fish oil supplementation for women at high risk of adverse outcomes from a pregnancy, but a small protective effect remains a possibility.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Cross-Over Studies
  • Docosahexaenoic Acids*
  • Double-Blind Method
  • Drug Combinations
  • Eicosapentaenoic Acid*
  • Fatty Acids, Omega-3 / adverse effects
  • Fatty Acids, Omega-3 / therapeutic use*
  • Female
  • Fetal Growth Retardation / prevention & control
  • Fish Oils / adverse effects
  • Fish Oils / therapeutic use*
  • Humans
  • Patient Compliance
  • Pregnancy
  • Pregnancy Complications, Cardiovascular / prevention & control*
  • Pregnancy Outcome
  • Pregnancy, High-Risk*
  • Proteinuria / prevention & control


  • Drug Combinations
  • Fatty Acids, Omega-3
  • Fish Oils
  • Maxepa
  • Docosahexaenoic Acids
  • Eicosapentaenoic Acid