Onwude 1995.
Methods | RCT | |
Participants | 232 women randomised (161 multigravida and 72 primigravida) Inclusion criteria: mean 24 weeks' gestation with high‐risk singleton pregnancy: history of 1 or more small babies (birthweight < 3rd percentile), history of pregnancy hypertension, history of unexplained stillbirth, or primigravida with abnormal uterine Doppler at 24 weeks' gestation Exclusion criteria: history of diabetes mellitus, chronic hypertension, asthma, use of anticoagulants, multiple pregnancy Setting: antenatal clinic, St James's University Hospital, Leeds, UK |
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Interventions |
SUPPLEMENTATION: EPA + DHA versus placebo Group 1: 2.7 g of MaxEPA/day (n = 113): 9 capsules/day provided 1.62 g EPA and 1.08 g DHA Group 2: control: matching air‐filled capsules (n = 119) Timing of supplementation: from a mean of 24 weeks to 38 weeks' gestation EPA + DHA dose/day: high: 1080 mg DHA + 1620 mg EPA |
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Outcomes | Women/birth: length of gestation; preterm birth < 37 weeks; preterm birth < 32 weeks; duration and mode of onset of labour; mode of birth; PIH, PE, adverse events (75 women only) Babies/infants/children: stillbirth; neonatal mortality; birthweight; birthweight < 3rd percentile | |
Notes | Sample size estimate was given for proteinuric hypertension All women were asked to avoid NSAIDs Adherence: 50% of women in the fish oil group and 57% of women in the placebo group took < 70% of capsules. Protocol variations: 1 woman in the omega‐3 arm took aspirin and 1 women in the placebo arm purchased fish oil privately. Funding: Yorkshire Region Locally Organised Research; GLAXO (Leeds); Sevens Seas (Hull) Declarations of interest: not reported |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Random numbers were generated by computer. |
Allocation concealment (selection bias) | Low risk | Random numbers were kept in sealed, opaque, numbered envelopes in the hospital pharmacy and pharmacy staff allocated the trial treatments. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Placebo capsules were identical to treatment capsules (44% of a subgroup of women identified that they were in the fish oil group). |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Outcome assessments were blinded. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 1/233 (0.4%) post‐randomisation exclusions (one woman with a multiple pregnancy was randomised in error) Adverse events were reported only for a small subsample; 76/233 (33%) women returned the questionnaires. |
Selective reporting (reporting bias) | High risk | Limited range of outcomes reported; no SDs reported for continuous outcomes (length of gestation; birthweight). |
Other bias | Low risk | Baseline characteristics were similar in supplement and placebo groups. |