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. 2013 Jul 31;2013(7):CD001449. doi: 10.1002/14651858.CD001449.pub3

Australia 2007.

Methods Randomised controlled trial.
Participants Antenatal and postnatal women with severe hypertension (some data for antenatal women presented separately).
Interventions IV Hydralazine – 5 mg boluses every 20 min for up to 3 doses, with a maximum dose of 15 mg (n = 47 antenatal, 49 babies).
Mini‐bolus Diazoxide – 15 mg boluses every 3 mins until the BP reached target or until 300 mg was given (20 x 15 mg mini‐bolus doses) within a 1‐hr period (n = 50, 52 babies).
The treatment was concurrent with MgSO4 infusion (4 g bolus IV over 15 min then 2 g per hr infusion for 24 h) at the commencement of treatment).
Outcomes Caesarean section rate; perinatal deaths; Apgar < 7 at 5 min; RDS; neonatal hypoglycaemia; neonatal ventilation.
Notes Antenatal and postnatal women with severe hypertension were included, but we have included the outcome data for the antenatal group.
 
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Method of sequence generation not described.
Allocation concealment (selection bias) Low risk “Patients were randomised by sequential selection of numbered opaque envelopes containing a randomised allocation.”
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Different regimens.
Blinding of outcome assessment (detection bias) 
 All outcomes High risk Different regimens.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Analysis by intention‐to‐treat. Protocol violations described. Study flow diagram clearly documented. No‐one lost to follow‐up or excluded from analysis.
Selective reporting (reporting bias) Low risk All expected outcomes reported.
Other bias Low risk None apparent. Baseline characteristics similar.