Israel 1986b.
Methods | Allocation concealment: not stated. Authors state "randomly allocated". 2 women with side‐effects on hydralazine crossed over to pindolol + hydralazine, and reported in this group. Data only included if available as intention‐to‐treat. Two arms | |
Participants | 44 women at < 37 weeks with BP >/= 150/90 mmHg x 2 at least 24 hrs apart. Excluded: insulin‐dependent diabetes, obstructive lung disease, contraindication to pindolol or hydralazine. | |
Interventions | Exp: oral hydralazine 50 mg/day to 100 mg/day + oral pindolol 10 mg/day to 25 mg/day (in 2 daily doses). (21 women) Control: oral hydralazine 50 mg/day to 100 mg/day (in 2 daily doses). (23 women) | |
Outcomes | Women: severe HT, proteinuria (> 1 g in 24 hr), side‐effects, changed drug due to side‐effects, caesarean section. Babies: preterm delivery, SGA (< 250 on Usher's curve), hypoglycaemia, hypothermia, low Apgar score. | |
Notes | No mention of which Korotkoff sound used. Funding: no information about funding source. Declaration of interests not described. |
|
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: "...randomly allocated...". 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. 2 women with side‐effects on hydralazine crossed over to pindolol + hydralazine, and reported in this group. Data only included if available as intention‐to‐treat. No information about funding source. Declaration of interests not described. |