India 2001.
Methods | See 'risk of bias' table below. | |
Participants | 100 women with eclampsia. 70 in first pregnancy and 79 recruited before delivery. | |
Interventions | Diazepam: 10 mg iv bolus. Then infusion of 40 mg/500 ml for 24 hr, rate titrated against conscious level. 20 mg/500 ml for a further 24 hr. Then 10 mg im, changed when possible to oral. For recurrent convulsions, 10 mg iv. MgSO4: 4 g in 25% MgSO4 over 10 min. The 5 g IM every 4 hr until 24 hr after delivery or, if postpartum at randomisation, for 24 hr. |
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Outcomes | Women: death, recurrence of convulsions, renal failure, pneumonia. Babies: denominators not reported. |
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Notes | Outcomes related to labour and delivery not reported separately for women randomised before delivery. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Adequate sequence generation? | Unclear risk | Sequence generated by Department of Statistics at Banaras Hindu University, but method not stated. |
Allocation concealment? | Unclear risk | Allocation was in envelopes, and patient was asked to choose one. No further information. |
Blinding? All outcomes | Unclear risk | Blinding not mentioned. Blinding of the 2 treatment regimens would have been impossible. |
Incomplete outcome data addressed? All outcomes | Unclear risk | Post‐randomisation exclusions not mentioned. No denominators reported for women randomised before birth. |