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%. |
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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). |
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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 |
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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. |