S‐Ramos 1994.
Methods | Double‐blind placebo‐controlled trial. 4/33 allocated calcium lost to follow‐up. | |
Participants | Women attending a hospital in Jacksonville, Florida, USA between 1989 and 1993. University hospital serving low‐income population Normotensive nulliparas; positive roll‐over test (281/1065) and positive angiotensin II infusion test at 20‐24 weeks' gestation (67/281). 67 were allocated to calcium (33) or placebo (34). Exclusion criteria: factors increasing the risk of gestational hypertension, including renal disease, collagen vascular disease, diabetes mellitus, chronic hypertension, multifetal pregnancy. |
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Interventions | Calcium supplementation with 2 g per day elemental calcium as 500 mg calcium carbonate tablets, vs identical placebo tablets. Compliance checked with electronic pillboxes. Compliance was 79% vs 81%. | |
Outcomes | Gestational hypertension (BP at least 140/90 mmHg on 2 occasions 4‐6 hours apart, on bedrest in hospital); pre‐eclampsia (gestational hypertension + proteinuria: 1+ or 300 mg/24 hours); severe pre‐eclampsia (pre‐eclampsia plus 1 of BP at least 160 mmHg systolic or 110 mmHg diastolic; proteinuria at least 5 g/24 hours; oliguria < 400 mL per day; elevated liver enzymes; thrombocytopenia < 100,000/microlitre; pulmonary oedema; severe epigastric pain). Birthweight (calcium 3245 (SD 414) vs placebo 3035 (542) g); mean gestational ages (35.6 vs 34.4 weeks); 5 minute Apgar < 7 (1/29 vs 1/34); cord arterial pH (7.25 (0.07) vs 7.20 (0.07)); fetal growth impairment (2/29 vs 4/34). |
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Notes | Jacksonville, Florida, USA. University hospital serving low‐income population 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 | Randomisation by computer‐generated list |
Allocation concealment (selection bias) | Low risk | Adequate |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Double‐blind. Tablets were prepared by a pharmaceutical company and were identical with respect to weight, size, flavour and appearance. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Double‐blind. Tablets were prepared by a pharmaceutical company and were identical with respect to weight, size, flavour and appearance. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | < 10% attrition |
Selective reporting (reporting bias) | Low risk | Expected outcomes reported |
Other bias | Low risk | Data entered before breaking the code. ITT analysis. 4/33 in the calcium group lost to follow‐up so 29 in calcium and 34 in placebo, however even if the 4 lost to follow‐up had PIH, results would still have significantly favoured the calcium group. |