Sudan 2002.
Methods | Allocation concealment: not stated. Authors state::"...patients were randomly allocated..." Two arms | |
Participants | 70 primigravid women with PE (BP =/> 90/109 mmHg x 2, 6 hrs apart plus 2+ proteinuria in dipsticks) at 28 to 36 weeks' gestation. Singleton pregnancy. | |
Interventions | Exp: oral methyldopa 750 mg/day to 4000 mg/day (34 women)
Control: oral no drug treatment. (36 women) All women in both groups were admitted to hospital for bed rest. |
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Outcomes | Women: BP, abruptio, imminent eclampsia, eclampsia, preterm delivery, caesarean section, maternal death. Babies: birthweight, IUGR, admission to SCBU (reported as 'referral of baby'), perinatal deaths, Apgar score. | |
Notes | Korotkoff IV sound used for DBP. 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 "...patients were randomly allocated...". |
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. |