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). |
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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. |
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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. |