South Africa 1998.
| Methods | Please see details below. | |
| Participants | 822 women with severe PE: at least 2 of DBP >/= 110 mmHg, significant proteinuria, symptoms of imminent eclampsia. Also, > 16 years, no previous anticonvulsant. | |
| Interventions | MgSO4: 4 g IV in 200 ml saline over 20 min, then 1 g/hr (200 ml over 4 hr) until 24 hr after delivery.
Placebo: 200 ml over 20 min, then 200 ml over 4 hours until 24 hr after delivery. Treatment stopped if urine output < 30 ml/hr. Serum monitoring not required. Women transferred from outlying clinics received 1 g clonazepam IV before transfer. Women not transferred were given 1 g clonazepam IV after randomisation. |
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| Outcomes | Woman: death, eclampsia, toxicity, antihypertensive therapy, caesarean section. Child: stillbirths. | |
| Notes | All women given clonazepam 1 mg. Recruitment over 13 years, 1982‐95. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Adequate sequence generation? | Unclear risk | Not described. |
| Allocation concealment? | High risk | Allocation by sealed opaque envelopes containing card marked solution A or B. Cards, but not envelopes, consecutively numbered. Envelopes distributed in batches of 20, with equal numbers of A and B. Solutions prepared by pharmacy, and identity of A and B changed periodically. |
| Blinding? All outcomes | Low risk | Investigators blinded to identity of solutions. |
| Incomplete outcome data addressed? All outcomes | Low risk | 123 excluded as envelopes and data sheets lost. Review of hospital records suggests no eclampsia amongst these women. Further 14 post randomisation exclusions (4 delivered before treatment, 3 no solution available, 4 MgSO4 before entry, 2 no consent, 1 anuric). None had eclampsia. |