Ogundipe 2016.
| Methods | RCT: FOSS: ISRCTN24068733 | |
| Participants | 300 women randomised (normal healthy controls (n = 50), women identified at risk of having a low birthweight baby either spontaneously (n = 100) or because of developing PE (n = 100), and women at risk of gestational diabetes (n = 50). Inclusion criteria: healthy women and women at risk of developing pregnancy‐related complications PE, fetal growth restriction, gestational diabetes Exclusion criteria: women with known allergy to fish and fish oil, non‐English speakers who decline the use of an interpreter and those unable or unwilling to attend follow‐up appointments; women with chronic disease such as HIV, cirrhosis or other chronic liver disease, hepatitis B and C carriers; women previously on regular pre‐conceptual fish oil supplement or who, for different reasons, were not able to give competent, written consent Setting: Chelsea and Westminster Hospital, London, UK |
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| Interventions |
SUPPLEMENTATION + OTHER AGENT: DHA + EPA + AA versus placebo Group 1: 2 capsules daily of DHA‐enriched formula (each capsule contained 300 mg of DHA, 42 mg of EPA and 8.4 mg of AA): total number randomised unclear Group 2: placebo: 2 capsules daily (high oleic acid sunflower seed oil – 721 mg oleic acid); total number randomised unclear Timing of supplementation: from 8‐12 weeks' gestation DHA + EPA dose/day: mid: 600 mg DHA + 84 g EPA |
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| Outcomes |
Women/birth: maternal neurobehavioural outcomes (listed in trial registration entry), maternal lipid profile Babies/infants/children: MRI brain scan findings; infant developmental outcomes (no outcomes yet reported by intervention and control group ‐ Ogundipe 2016 reports overall GA, birthweight, birth length, head circumference at birth, low birthweight) |
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| Notes | No outcomes could be used in this review to date. Funding: The Mother and Child Foundation, Letten Foundation, Waterloo Foundation and Vifor Pharma, Switzerland. Declarations of interest: not reported |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Not reported |
| Allocation concealment (selection bias) | Unclear risk | Not reported |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Not reported |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not reported |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Not reported |
| Selective reporting (reporting bias) | Unclear risk | Not reported |
| Other bias | Unclear risk | Not reported |