Nimodipine SG 2003.
Methods | Please see details below. | |
Participants | 1750 women with PE, planned delivery and no previous MgSO4. BP ≥140/90 mmHg and 1+ proteinuria plus 1 of: headache, clonus, visual disturbance, epigastric pain, oliguria, pulmonary oedema, raised liver enzymes, haemolysis, oligohydramnios, IUGR. | |
Interventions | MgSO4: according to local protocol. Either 4 g IV then 1 g/hr, or 6 g IV then 2 g/hr. Nimodipine: 60 mg 4 hourly, orally. Both regimens continued either for 24 hours total, or until 24 hours after delivery. Serum monitoring not required. |
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Outcomes | Woman: eclampsia, stroke, coagulopathy, respiratory problems, cardiac failure, antihypertensive drugs, side effects, abruption, caesarean section, PPH. Baby: RDS, hypotonia, intubation, hypotension. |
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Notes | Recruitment at 14 hospitals in 8 countries. Data for stillbirths and neonatal deaths not reported. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Adequate sequence generation? | Unclear risk | Randomisation stratified by centre, blocks of 6. |
Allocation concealment? | Unclear risk | Sealed opaque envelopes. |
Blinding? All outcomes | High risk | Unblinded trial, but primary outcome was described as "binary, objective, and not subject to measurement bias". |
Incomplete outcome data addressed? All outcomes | Unclear risk | Recruitment 1995‐2000. 100 women (6%) excluded from analysis: 99 did not get allocated treatment, 1 withdrawn. Recruitment stopped early following interim analysis. |