Nigeria 2004.
Methods | See 'risk of bias' table below. | |
Participants | 60 women with eclampsia, 25% delivered prior to entry. | |
Interventions | Diazepam: loading dose of 10 mg iv over 2 minutes administered and repeated when convulsion recurred. Then 10 mg iv every 6 hours to keep patient sedated but arousable for next 24 hours. Subsequent doses were held if the patient was still sedated when the next dose due. MgSO4: "Zuspan's" method, no further details given. |
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Outcomes | Woman: recurrence of convulsions, death, life threatening events, including pulmonary edema, cardiac arrest, respiratory depression, aspiration pneumonitis, renal failure, disseminated intravascular coagulation, cerebrovascular accidents, liver failure, postpartum haemorrhage, Glasgow Coma Score on admission and 24 hours after commencement of treatment. For women randomised prior to delivery: mode of delivery. Baby: Apgar scores, need for neonatal unit for intensive care, and perinatal deaths. |
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Notes | MgSO4 was the unfamiliar treatment. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Adequate sequence generation? | High risk | Computer‐generated random numbers, but then this was used to prepare treatment packs labelled "A" or "B". |
Allocation concealment? | High risk | Sealed treatment packs marked "A" or "B," identical in size, shape, weight, and feel. Not clear in what order these packs were opened. |
Blinding? All outcomes | High risk | Blinding not mentioned. Blinding of the 2 treatment regimens would have been impossible. |
Incomplete outcome data addressed? All outcomes | Unclear risk | There is a discrepancy in some denominators, as the numbers for 'postpartum eclampsia' are not the same as randomised after delivery'. |