Kumar 2009.
Methods | Randomised, double‐blind, placebo‐controlled trial | |
Participants | Women were recruited between January 2005 and December 2007 at a hospital in New Delhi, India. Healthy normotensive primigravid women with uncomplicated single pregnancy; pregnancy 12 to 25 weeks' gestation, known date of the last menstrual period, and intention to deliver at Lok Nayak Hospital, New Delhi. Study population had a low dietary calcium. Exclusions: multiple pregnancy, polyhydramnios, fetal malformations, diabetes, chronic hypertension, renal disease, cardiovascular disease, urolithiasis, or BP of 140/90 mmHg or higher at first visit or at enrolment. |
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Interventions | 4 tablets (2 g calcium or placebo) were taken daily. | |
Outcomes | Pre‐eclampsia (SBP > 140 mmHg and DBP > 90 mmHg on 2 occasions 4 hours apart after 20 weeks' pregnancy in women normotensive previously, together with proteinuria > 300 mg/24 h or 1+ on a clean‐catch dipstick in the absence of urinary infection); eclampsia; preterm delivery; caesarean section. Baseline characteristics comparable. |
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Notes | Imbalanced groups: 290 allocated to calcium, 262 to placebo group. 17 and 11 lost to follow‐up so 273 and 251 analysed respectively. See below. Source of funding: University Grant Commission, New Delhi, India. CoI: not stated. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Simple randomisation sequence developed manually |
Allocation concealment (selection bias) | Low risk | Coded numbers assigned to treatment packets and distributed to participants using the random number sequence. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Double‐blind. Calcium and placebo tablets were identical. Randomisation code broken after completion of the trial. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Double‐blind. Calcium and placebo tablets were identical. Randomisation code broken after completion of the trial. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Attrition < 10% |
Selective reporting (reporting bias) | Low risk | Expected outcomes reported. |
Other bias | High risk | Imbalance in size of groups. The authors were contacted regarding the imbalance and they explained that a random sequence was generated for 600 participants (unblocked) but recruiting was stopped at 552 participants and so 48 numbers remained unallocated. |