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. 2015 Feb 25;2015(2):CD007079. doi: 10.1002/14651858.CD007079.pub3

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).
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.
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.
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.