Niromanesh 2001.
Methods | Double‐blind, placebo‐controlled clinical trial. | |
Participants | Women attending a hospital in Tehran, Iran. Dates of recruitment not stated Women at high risk for pre‐eclampsia: positive 'roll‐over' test and at least 1 risk factor for pre‐eclampsia; 28‐32 weeks' pregnant; BP < 140/90 mmHg. Exclusion criteria: chronic medical conditions. Not defined as low or adequate calcium intake (from table 1 dairy intake appears to be about 200 mL + 400 g per day) |
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Interventions | Elemental calcium 2 g daily (500 mg 6‐hourly) or placebo, coded by the pharmacy | |
Outcomes | Pre‐eclampsia: an increase (30 mmHg) of SBP above 14 mmHg and an increase (15 mmHg) of DBP above 90 mmHg, twice 4‐6 hours apart, with proteinuria 1+; duration of pregnancy (39.5 SD 0.8 vs 37.7 SD 2.5 weeks); birthweight (3316 SD 308 vs 2764 SD 761 g); weekly maternal weight increase (no difference). | |
Notes | No loss to follow‐up Source of funding: not stated; supplements and placebo tablets were provided by a pharmaceutical company. CoI: not stated. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Women were "randomly assigned". |
Allocation concealment (selection bias) | Low risk | Adequate. Manufacturer coded the tablets which had same packaging and physical characteristics. A pharmacy dispensed the tablets. |
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 | No incomplete outcome data (sample size = 30) |
Selective reporting (reporting bias) | Low risk | Expected outcomes reported |
Other bias | Unclear risk | No incomplete data or loss to follow‐up |