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

Samimi 2015.

Methods RCT: IRCT20131226562N16
Participants 56 women randomised
Inclusion criteria: pregnant women 18‐40 years, diagnosed with GDM (1 step 2‐hour 75 g OGTT at 24‐28 weeks GA using ADA 2014 criteria, i.e. fasting glucose ≥ 92 mg/dL,1‐hour ≥ 180 mg/dL and 2‐hour ≥ 153 mg/dL)
Exclusion criteria: women requiring insulin therapy, women with PPROM, placental abruption, PE, eclampsia, chronic hypertension, hypothyroidism, urinary tract infection, smokers and those with kidney or liver diseases or those taking oestrogen therapy
Characteristics: women had high omega‐6 concentrations
Setting: Kashan, Iran (January‐March 2014)
Interventions SUPPLEMENTATION: EPA + DHA + other omega‐3 versus placebo
Group 1: 1000 mg omega‐3 fatty acid (1 ‘pearl’ per day for 6 weeks; the pearl contained 70% LCPUFA (180 mg EPA, 120 mg DHA and 400 mg of other omega‐3 fatty acids)); total number randomised: n = 28
Group 2: placebo (1 ‘pearl’ per day for 6 weeks; the pearl contained 500 mg liquid paraffin); total number randomised: n = 28
Timing of supplementation: 6 weeks from 24‐28 weeks GA
All women: asked not to alter their routine physical activity or usual dietary intakes throughout the study and not to consume any supplements other than the 1 provided to them by the investigators
DHA + EPA dose/day: low: 120 mg DHA + 120 mg EPA
Outcomes Women: insulin resistance (HOMA‐IR); HOMA‐B; plasma glucose; QUICKI; lipid profile; dietary records; adherence, CRP (ng/mL)
Babies/infants/children: nil
Notes Funding: Kashan University of Medical Sciences
Declarations of interest: none reported
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Computer‐generated random numbers
Allocation concealment (selection bias) Low risk Quote: "Randomization and allocation were concealed from the researchers and participants until the main analyses were completed. A trained midwife at maternity clinic did the randomized allocation sequence, enrolled participants and assigned participants to intervention"
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Quote: "The appearance of placebo ... color, shape, size, and packaging, were identical to omega‐3 fatty acid capsule"
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Not reported, but probably done.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk 3/28 women in each group were lost to follow‐up (omega‐3: 1 insulin therapy and 2 hospitalised); placebo (2 insulin therapy and 1 placental abruption). However results for all 56 women were analysed.
Selective reporting (reporting bias) Unclear risk No baby or child outcomes reported.
Other bias Low risk No clear baseline differences.