Dilli 2018.
| Methods | RCT: NCT02371343 (MaFOS‐GDM) | |
| Participants | 140 women randomised Inclusion criteria: pregnant women, 18‐40 years old, between 24‐28 weeks GA, residents of one of the study centres, planning to remain in the area for the next year, subsequently diagnosed with gestational diabetes mellitus Setting: three tertiary maternity and children's hospitals from different regions in Turkey (trial conducted from January 2015 to January 2017) |
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| Interventions |
SUPPLEMENTATION: EPA + DHA versus placebo Group 1: omega‐3 LCPUFA 1200 mg/day: 384 mg EPA; 252 mg DHA (Ocean Plus): n = 70 Group 2: placebo (sunflower oil ‐ similar in appearance and taste to the fish oil capsules): n = 70 Timing of supplementation: from 26‐27 weeks till birth (˜ 9 weeks) DHA + EPA dose/day: mid: 252 mg DHA + 384 mg EPA |
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| Outcomes |
Women/birth: GWG; caesarean; preterm birth < 37 weeks Babies/infants/children: cord Insulin‐like growth factor 1 (IGF)‐1 DNA methylation; birth weight; macrosomia (> 90th percentile for GA); head circumference at birth; hospitalisation (not further specified) |
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| Notes |
Funding: Republic of Turkey Ministry of Health Central Directorate for Health Research Declaration of interest: authors declared no conflict of interest |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote: "balanced blocks" |
| Allocation concealment (selection bias) | Unclear risk | Quote: "sealed envelopes" |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: placebo‐controlled |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not reported |
| Incomplete outcome data (attrition bias) All outcomes | High risk | Omega‐3 LCPUFA: 18/70 lost to follow‐up or refused to continue Placebo: 2/70 refused to continue Judged to be at high risk due to differential rates of losses between omega‐3 and placebo groups (also see other bias text). |
| Selective reporting (reporting bias) | Unclear risk | Limited number of pregnancy outcomes reported |
| Other bias | Unclear risk | No apparent evidence of other bias, though GDM was more often managed by diet only in the omega‐3 group than in the ‐placebo group |