Argentina 1987.
Methods | Allocation concealment: not stated. Authors state "open randomised study". Two arms. | |
Participants | 20 women with SBP > 159 mmHg and/or DBP > 99 mmHg x 2, 24 hrs apart, +/‐ proteinuria. Excluded: > 1 drug to control BP, or hypertensive emergency. | |
Interventions | Exp: oral ketanserin 20 mg/day to 80 mg/day (10 women) Control: oral methyldopa 500 mg/day to 2000 mg/day (10 women) | |
Outcomes | Women: none reported. Babies: stillbirth, neonatal death, birthweight (mean), gestation at delivery (mean). | |
Notes | Interim report of study ongoing in 1987. Methods for measuring BP not mentioned. Funding: no information about funding source. Declaration of interests not described |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not described. |
Allocation concealment (selection bias) | Unclear risk | Not described: quote: "...open randomised study..." no further details. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Open‐label trial. |
Blinding of outcome assessment (detection bias) All outcomes | High risk | No. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No. |
Selective reporting (reporting bias) | Unclear risk | Assessment from published study report. |
Other bias | Unclear risk | Groups appear comparable at baseline. No information about funding source. Declaration of interests not described. |