Algeria 2011.
Methods | Randomised controlled trial. | |
Participants | 164 primiparous women consulting before the 10th week of amenorrhoea without previous vasculo‐renal pathology. Excluded: counter‐indication to use of aspirin, chronic arterial hypertension before pregnancy, chronic nephropathy, known auto‐immune disorder, twin pregnancies, diabetes. |
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Interventions | Exp: aspirin 100 mg/day, taken in the evening from 8‐10 weeks' gestation to 36 weeks' gestation Control: unclear ‐ refer to the non‐treated group most of the time, but refer to placebo group once in paper. |
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Outcomes | Women: maternal complications (gestation hypertensive disorders). Babies: gestation length, newborn weight, fetal complications. |
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Notes | Trial conducted in Blida Hospital, Algeria. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "randomization for treatment (using anonymous sealed envelopes)" Insufficient information about the sequence generation process to permit judgement. |
Allocation concealment (selection bias) | Unclear risk | Quote:"anonymous sealed envelopes". No information about whether opaque or numbered. |
Blinding (performance bias and detection bias) All outcomes | High risk | Quote:"The patient and the study promoter were not blinded to the conditions of treatment." |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Appears to be no missing outcome data, i.e. number randomised = number reported in outcomes. |
Selective reporting (reporting bias) | Low risk | Protocol not available but all expected outcomes are reported. |
Other bias | Unclear risk | Baseline characteristics: Quote:"The control and treated groups were not statistically different with respect to age, body mass index, gestity and parity (Table 1)." However, did not report baseline BP measures. |