Villar 1990.
Methods | Double‐blind, randomised trial | |
Participants | Johns Hopkins Hospital, Baltimore, 1985‐1988 Pregnant women 17 years or younger; no underlying medical disorders; most were nulliparous with known last menstrual period and singleton pregnancy |
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Interventions | 2 g elemental calcium as 500 mg calcium carbonate tablets, vs placebo tablets. All women were prescribed prenatal vitamin tablets containing 200 mg calcium and 100 mg magnesium per day. | |
Outcomes | Preterm labour; preterm delivery < 37 weeks (calcium 7.4 vs placebo 21.1%); delivery 30‐37 weeks; idiopathic prematurity; spontaneous prematurity; low birthweight (< 2500 g) (calcium 9.6% vs placebo 21.1%); postdates > 42 weeks (calcium 7.4 vs placebo 5.3%); impaired fetal growth (3.2 vs 3.2%); premature rupture of membranes (2.1 vs 1.0%); Apgar score < 8 at 5 minutes (4.4 vs 10.5%) | |
Notes | Source of funding: grants from the National Dairy Board and the National Dairy Council. CoI: not stated. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated list of random numbers |
Allocation concealment (selection bias) | Low risk | Opaque envelopes with bottle numbers; project co‐ordinator responsible for assigning treatment. Identical tablets and containers were prepared at The Johns Hopkins Hospital pharmacy. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Double‐blind |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Double‐blind |
Incomplete outcome data (attrition bias) All outcomes | Low risk | < 10% attrition |
Selective reporting (reporting bias) | Low risk | Expected outcomes reported |
Other bias | Unclear risk | Baseline characteristics similar except for maternal weight (higher in placebo group, P < 0.01) |