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

Taherian 2002.

Methods Type of study: randomised controlled study.
Method of treatment allocation: the sampling method was non probability convenience. Used table of random numbers to assign each case independently to 1 of 3 groups.
Stratification: not stated.
 Placebo: no (no treatment).
 Sample size calculation: not stated.
 Intention‐to‐treat analyses: yes.
 Losses to follow‐up: 0%.
Participants Location: Isfahan Health Centre, Iran.
Time frame: April 1998 to March 2001.
 Eligible criteria: nulliparity, single gestation, first antenatal visit before 20 weeks of gestation, BP < 130/80 mmHg and no proteinuria by urine dipstick.
 Exclusion criteria: had history of cardiovascular, renal disease or endocrinologic problem, medical or obstetric complications and those with known hazardous condition (multiple gestation, hydatidiform mole).
 Total recruited: 990 healthy pregnant women (n = 330 participants/group).
Interventions Group 1: received 75 mg aspirin /day, n = 330.
 Group 2: received 500 mg calcium carbonate/day, n = 330.
 Group 3: no treatment as control group, n = 330.
 Started treatment at 20 weeks until delivery.
Outcomes
  1. BP.

  2. Pregnancy outcomes; GA, birthweight, preterm birth, Apgar score, fetal growth restriction, perinatal death.

Notes Comment: the results were reported as mean and 95% CI; we changed them into SD.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "The sampling method was non probability convenience. We used table of random numbers to assign each case independently to one of three groups."
Allocation concealment (selection bias) Unclear risk Comment: the method of allocation concealment was not stated.
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Quote: "Group 1 received 75 mg aspirin; group 2 received 500 mg oral calcium‐D daily; and the control group 3 received no medication at all."
Comment: it was impossible to blind because the difference between drug and no treatment in control group.
Blinding of outcome assessment (detection bias) 
 All outcomes High risk Quote:" All cases received prenatal care according to the approved model, BP, body weight and maternal height were measured."
Comment: assessors were not blinded because the participants received different treatments.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Comment: all enrolled participants were included in the analyses.
Missing data = 0%.
Selective reporting (reporting bias) Low risk None identified.
Other bias Low risk None identified.