Rivas‐Echeverria 2000.
Methods | RCT | |
Participants | 127 women randomised Inclusion criteria: pregnant women < 29 weeks' gestation at high risk of PE, nulliparity, previous PE, obesity, hypertension, < 20 years old, diabetes, nephropathy, mean arterial pressure < 85 mmHg, positive roll‐over test, “black race”, family history of hypertension or PE, twin pregnancy, poor socioeconomic conditions Exclusion criteria: none reported Setting: Mérida, Venezuela |
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Interventions |
SUPPLEMENTATION + OTHER AGENTS: omega‐3 ( + aspirin, vitamins C and E) versus placebo Group 1: fish oil capsules 3 times a day (omega‐3 content not reported); aspirin 100 mg 3 times a week, vitamin C 500 mg 3 times a day, vitamin E 400 IU a day; total number randomised = 63 Group 2: placebo (not further described); total number randomised = 64 Timing of supplementation: not reported DHA + EPA dose/day: unclear |
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Outcomes | Women/birth: PE; “no serious maternal or neonatal side effects of treatment occurred in either group” | |
Notes |
Funding: none reported Conflicts of interest: none reported |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: “randomly divided” |
Allocation concealment (selection bias) | Unclear risk | Quote: “randomly divided” |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: “triple‐blind”; probably done |
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) | High risk | Only 1 outcome fully reported. |
Other bias | Unclear risk | Not sufficient reporting to determine risk of other bias. |