Iran 2011.
Methods | Randomised controlled trial. Women’s Hospital, Tehran, Iran. | |
Participants | 50 pregnant women admitted for labour diagnosed with severe PE or chronic hypertension superimposed by PE, of at least 24 weeks' gestation. Hypertensive emergency was defined as measured sustained SBP ≥ 170 mmHg or DBP ≥ 105 mmHg. Exclusion criteria: women diagnosed with heart disease or severe renal impairment or cerebrovascular accident. |
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Interventions | Oral nifedipine 10 mg capsules, administered initially at a dose of 10 mg, then 20 mg, with intervals of 20 min up to a maximum of 5 doses or when desired BP (150/90‐100) achieved (n = 25). IV hydralazine 5 mg, administered initially at 5 mg and repeated in 10 mg doses, up to maximum of 5 injections in intervals of 20 min. IV hydration were all set at rate of 125 mg/h (n = 25). |
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Outcomes | Primary: time and frequency of doses to achieve target BP. Secondary: urinary output; maternal (headache; hypotension; flushing; nausea) and neonatal side‐effects (fetal heart rate abnormalities; neonatal Apgar score). |
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Notes | All women received prophylactic infusion of MgSO4 continually to avoid convulsion. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Referred to a random number table “We dispensed either nifedipine or hydralazine according to a random number table”. |
Allocation concealment (selection bias) | Unclear risk | Not described. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | No blinding, “It was not possible for us to blind the study, because there was no placebo group due to ethical considerations”. |
Blinding of outcome assessment (detection bias) All outcomes | High risk | No blinding, “It was not possible for us to blind the study, because there was no placebo group due to ethical considerations.”. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No mention of loss to follow‐up. |
Selective reporting (reporting bias) | Low risk | All expected outcomes fully reported upon. |
Other bias | Low risk | None apparent. Baseline characteristics of 2 groups similar. |