D'Almedia 1992.
Methods | RCT (3 arms) | |
Participants | 100 women (from 2 of the 3 arms) Inclusion criteria: primiparous and multiparous women, aged 14‐40 years and ≤ 16 weeks' gestation. Exclusion criteria: none reported Characteristics: 76% had a recent history of malaria or fever of unknown origin, 34% had a history of sickle cell trait or disease, 37% had a history of anaemia, 21% had a history of pregnancy hypertension or other hypertension and 4% had a previous preterm birth. Setting: Luanda, Angola |
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Interventions |
SUPPLEMENTATION + OTHER AGENT: GLA + EPA + DHA (omega 6/omega 3) versus placebo Group 1: 8 capsules/day evening primrose oil + fish oil, providing a total of 296 mg GLA, 144 mg EPA and 80 mg DHA/day: total number randomised = 50 Group 2: 8 capsules olive oil/day (without vitamin E): total number randomised = 50 (The third arm (magnesium oxide: n = 50) was not considered for this review): Timing of supplementation: 6 months DHA + EPA dose/day: low: 80 mg DHA + 144 mg EPA |
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Outcomes | Women: PIH, PE (hypertension (rise in SBP > 30 mmHg and/or a rise in DBP > 15 mmHg); oedema (visible fluid accumulation in the ankles and feet), and proteinuria (protein > 1 determined by test tape) any time during the pregnancy), eclampsia. Babies/infants/children: birthweight (< 2000 g and > 3000 g (not used for LGA outcome)). | |
Notes |
Funding: GLA, EPA, DHA tablets and placebo tablets were prepared by Efamol Research Institute and Efamol Ltd Declarations of interest: not reported Reported dietary intake of women in all groups at study entry was poor. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Women "randomly assigned using a random number table" |
Allocation concealment (selection bias) | Low risk | Quote: "the code of the capsules was not made known by the manufacturer, until the end of the treatment period" |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Olive oil and evening primrose oil + fish oil capsules identical (but both different to magnesium oxide), so fully blinded with regard to the fish oil/evening primrose and placebo comparison. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Outcome assessments partially blinded ‐ olive oil and evening primrose oil + fish oil capsules identical (but both different to magnesium oxide), so fully blinded with regard to the fish oil/evening primrose and placebo comparison. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Not specifically reported |
Selective reporting (reporting bias) | Unclear risk | Outcomes such as preterm birth and perinatal mortality were not reported |
Other bias | Unclear risk | Baseline nutritional profiles (determined by dietary recall) differed (placebo group higher caloric intake; higher animal protein; higher total fat; higher “fish fat”; higher cholesterol; higher fibre; higher potassium) |