Laivuori 1993.
Methods | RCT (3‐arms) | |
Participants | 18 women randomised Inclusion criteria: women with PE (admitted to hospital between 26 and 37 weeks' gestation because of BP consistently exceeding 140/100 mmHg; 8 women also had proteinuria) Exclusion criteria: none reported Setting: Helsinki, Finland |
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Interventions |
SUPPLEMENTATION: omega‐3 versus LA + GLA (Primrose oil) versus placebo Group 1: fish oil: 10 MaxEPA capsules (180 mg EPA, 120 mg DHA per capsule): total number randomised: n = 5 (3) Group 2: primrose oil: 10 Preglandin capsules (375 mg linolenic acid and 45 mg gammalinolenic acid per capsule): total number randomised: n = 7 (4) Group 3: placebo (10 capsules each containing 500 mg of maize oil and 500 mg olive oil); total number randomised: n = 6 (5) All women: intervention between 31‐36 weeks' gestation; bed rest in hospital for 2 days before randomisation Median duration and range of supplementation was:
Women were advised to follow their normal diets. DHA + EPA dose/day: daily dose unclear |
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Outcomes | Women/birth: prostanoids (urine); clinical signs of PE; birthweight (reported as median and range); BP (reported as % of pretreatment levels) | |
Notes | 2 women used betablockers (metoprolol 100 mg/day) and 1 used dihydrazaline 50 mg/day. No aspirin‐like drugs were allowed. No outcomes could be meta‐analysed Funding: Preglandin capsules (Suomen Rohdos, Turku, Finland); MaxEpa and placebo capsules (Orion OY, Kuopio, Finland) 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 | Reported as “in randomized order” |
Allocation concealment (selection bias) | Unclear risk | Sealed envelopes |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Capsules of identical appearance |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Not reported, but probably done. |
Incomplete outcome data (attrition bias) All outcomes | High risk | 6/18 (33%) women excluded: 3 women gave birth before samples could be collected and 3 additional women failed to collect adequate urine samples. |
Selective reporting (reporting bias) | Unclear risk | Limited number of outcomes reported. |
Other bias | High risk | Median length of supplementation differed substantially between the 3 groups. |