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. 2010 Nov 10;2010(11):CD000025. doi: 10.1002/14651858.CD000025.pub2

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.
Outcomes Woman: eclampsia, stroke, coagulopathy, respiratory problems, cardiac failure, antihypertensive drugs, side effects, abruption, caesarean section, PPH.
Baby: RDS, hypotonia, intubation, hypotension.
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Unclear risk Recruitment 1995‐2000. 100 women (6%) excluded from analysis: 99 did not get allocated treatment, 1 withdrawn.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.