Herrera 1998.
Methods | Allocation sequence was generated using random number tables, and prepared by an administrative staff member. | |
Participants | Recruitment May 1995 to May 1996, 3 hospital outpatient clinics in Cali, Colombia. 676 healthy primigravid women screened. Primigravidas with risk factors for pre‐eclampsia (high biopsychosocial risk, positive roll‐over test and high mean BP (> 85 mmHg) selected). |
|
Interventions | 450 mg linoleic acid plus 600 mg calcium (n = 44) vs identical looking placebos (n = 45) in the third trimester. | |
Outcomes | Biochemical studies; maternal and neonatal clinical outcomes. | |
Notes | 1 study group excluded for taking ASA; 2 from control group lost to follow‐up Source of funding: the study was supported by a grant from the National Institute of Science and Technology of Colombia. CoI: not stated. |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | “ allocated randomly.” |
Allocation concealment (selection bias) | Low risk | “ allocated randomly.” |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | “Double blind, placebo controlled trial.” |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | “Double blind, placebo controlled trial.” |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 1 from study group excluded for taking ASA; 2 from control group lost to follow‐up. |
Selective reporting (reporting bias) | Low risk | Main outcomes reported |
Other bias | Low risk | “Double blind, placebo controlled trial.” |