UK 1989.
Methods | Allocation concealment: drug and placebo sent by manufacturer to hospital pharmacy with list of random numbers. Then dispensed by pharmacists. 5 centres.
Withdrawals: 8 (5%), 6 exp, 2 control. 2 women withdrew, 1 treated with ward stock labetalol, 1 developed rash, and 4 did not fulfil entry criteria. Two arms |
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Participants | 152 women from antenatal wards at 20 to 38 weeks' gestation with SBP 140 mmHg to 160 mmHg and DBP 90 mmHg to 105 mmHg x 2, 24 hrs apart, and no proteinuria. Excluded: history of HT, renal, metabolic, cardiovascular, respiratory or collagen disease. | |
Interventions | Exp: oral labetalol 100 mg x 3/day to 200 mg x 3/day. Control: oral identical placebo. | |
Outcomes | Women: mean BP, severe HT, proteinuria (undefined), induction of labour, caesarean section, days in hospital (mean), side‐effects. Babies: perinatal death, preterm delivery (< 37 weeks), SGA (< 5th centile), admission to SCBU, RDS. | |
Notes | Korotkoff phase IV used for DBP. Conventional sphygmomanometers used to measure BP. Funding: funded by industry. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | List of random numbers. |
Allocation concealment (selection bias) | Low risk | Drug and placebo sent by manufacturer to hospital pharmacy with list of random numbers. Then dispensed by pharmacists. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Double‐blind, placebo‐controlled trial. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Yes. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 8 women excluded after randomisation (5.3%), without specification of the group they belonged. |
Selective reporting (reporting bias) | Unclear risk | Assessment from published study report. |
Other bias | High risk | Funded by industry. |