Kumar 2009.
Methods | Type of study: double‐blinded randomised trial with simple randomisation sequence developed manually. The blinding of study participants and investigators was done by assigning coded numbers to the package. Method of treatment allocation: the packages were distributed to the participants using the random number in sequence. Placebo: yes. Intention‐to‐treat analyses: no, only participants 524 who delivered in hospital. Losses to follow‐up: 28 from 552 = 5.1% (17 in treatment group and 11 in placebo group). |
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Participants | Location: At Lok Nayak Hospital, New Delhi, India. Time frame: January 2005 and December 2007. Eligible criteria: healthy normotensive primigravidas with non complicated singleton pregnancy, 12‐25 weeks' gestation Exclusion criteria: multiple pregnancy, polyhydramnios, fetal malformation, diabetes, chronic hypertension, renal disease, cardiovascular disease, urolithiasis or BP > 140/90 mmHg. Total recruited 552 pregnant women, treatment group, n = 290, placebo group, n = 262. |
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Interventions | Oral calcium carbonate 4 tablets daily (500 mg each) compared with placebo, 4 tablets daily, from GA 12‐25 week until delivery. | |
Outcomes | 1. BP. 2. Maternal and neonatal outcomes including: pre‐eclampsia, preterm delivery, induction of labour, CS, fetal distress during labour, meconium during labour, GA at delivery, gestational duration at delivery (wk; < 32, 32 to 36, 37 to 40, > 40), birthweight g, birthweight (kg < 2, 2 to 2.5, 2.5 to 4), small‐for‐gestational age, stillbirth. |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Double‐blinded randomised trial with simple randomisation sequence developed manually. |
Allocation concealment (selection bias) | Low risk | Allocation concealed by assigning treatment packages with code, which was unbroken until the end of the study. The packages were distributed to the participants using the random number in sequence. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | The blinding of study participants and investigators was done by assigning coded numbers to the package. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | All women were followed up in prenatal clinic in a routine manner. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Losses to follow‐up: 28 from 552 = 5.1% (17 in treatment group and 11 in placebo group). |
Selective reporting (reporting bias) | Low risk | The preplanned outcomes were reported. |
Other bias | Low risk | None identified. |