USA 1979.
Methods | Allocation concealment: not stated. Authors state: "allocated randomly to treatment or no treatment". Two arms | |
Participants | 58 women with HT before pregnancy or BP >/= 140/90 mmHg x 2 more than 24 hrs apart before 20 weeks' gestation. Excluded: DBP > 100 mmHg, nulliparous, other major medical or obstetric problem. | |
Interventions | Exp: oral methyldopa 750 mg/day to 2000 mg/day, oral hydrochlorothiazide 50 mg/day, oral hydralazine 75 mg/day to 250 mg/day. (29 women) Control: no antihypertensive. (29 women) | |
Outcomes | Women: severe HT, proteinuria (> 1+ or > 300 mg/L in 24 hrs), caesarean section. Babies: perinatal death, gestation at delivery, birthweight < 2500 g, fetal distress, SGA (undefined). | |
Notes | No information about how BP measured. In exp group, 11 women had methyldopa + hydrochlorothiazide, 10 hydralazine + hydrochlorothiazide, 8 had all 3 drugs. 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: "...allocated randomly to treatment or no treatment...". 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. |