Safety of Omega‐3 Fatty Acid Supplementation During Pregnancy: A Meta‐Analysis of Randomized Controlled Trials
Abstract
Supplementation with omega‐3 fatty acid (FA) during gestation has been associated with potential benefits, but its safety has not been comprehensively evaluated. This meta‐analysis aimed to assess the maternal and neonatal safety of omega‐3 FA supplementation in pregnancy. Comprehensive literature retrieval was performed in PubMed, EMBASE, and the Cochrane Library up to October 17, 2022, to identify randomized controlled trials (RCTs) reporting safety outcomes. The primary endpoints were maternal serious adverse events (SAEs), neonatal SAE, and infant death. Ultimately, seven RCTs involving 9957 pregnant women met the inclusion criteria for meta‐analysis. The occurrence of maternal SAE (relative risk [RR]: 1.09, 95% confidence intervals [CI]: 0.70–1.69, and p = 0.705) and neonatal SAE (RR: 0.98, 95% CI: 0.67–1.44, and p = 0.923) did not vary between placebo and omega‐3 FA supplementation groups. Besides, omega‐3 FA supplementation tended to reduce the risk of infant death, although this was not statistically significant (RR: 0.72, 95% CI: 0.47–1.10, and p = 0.132). The overall risk of bias across studies was relatively low. Sensitivity analyses confirmed the robustness of the results, and Begg’s and Egger’s tests indicated no publication bias (all p > 0.050). In conclusion, omega‐3 FA supplementation during pregnancy appears safe for both maternal and infants, our findings supporting its evidence‐based clinical use.
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 9,957 participants or records.
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