Rumiris 2006.
Methods | Double‐blind, placebo‐controlled trial. Participants randomised according to a computer‐generated random number sequence by an independent third party who had no conflict of interest in the study. | |
Participants | Women attending a university hospital in Indonesia between March 2003 and June 2004 60 pregnant women with low antioxidant status at 8 to 12 weeks of gestation Exclusion criteria: 1) history or current use of anti‐hypertensive medication or diuretics; 2) use of vitamin C > 150 mg and/or vitamin E > 75 IU per day; 3) known placental abnormalities; 4) current pregnancy as a result of in vitro fertilisation; 5) regular use of platelet active drugs or non‐steroidal anti‐inflammatory drugs (NSAIDs); 6) known fetal abnormalities; 7) documented uterine bleeding within a week of screening; 8) uterine malformations; 9) history of medical complications. |
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Interventions | Supplementation with calcium (800 mg), N‐acetylcysteine (200 mg), Cu (2 mg), Zn (15 mg), Mn (0.5 mg), and selenium (100 mcg) and vitamins A (1000 IU), B6 (2.2 mg), B12 (2.2 mcg), C (200 mg), and E (400 IU), from 8 to 12 weeks of gestation throughout pregnancy Both groups received Fe (30 mg) and folic acid (400 mcg). Placebo supplement’s size and appearance were matched with those of antioxidants. |
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Outcomes | Maternal: pre‐eclampsia, hypertension, proteinuria and abortion. Perinatal: IUGR, intrauterine fetal death, preterm delivery (before 37 weeks). |
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Notes | Source of funding: not stated. CoI: not stated. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Participants were randomised according to a computer‐generated random number sequence by an independent third party who had no conflict of interest in the study. |
Allocation concealment (selection bias) | Low risk | Participants were randomised according to a computer‐generated random number sequence by an independent third party who had no conflict of interest in the study. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Double‐blind, placebo‐controlled trial |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Double‐blind, placebo‐controlled trial |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No loss to follow‐up |
Selective reporting (reporting bias) | Unclear risk | Unable to comment |
Other bias | Low risk | None noted |