| Methods |
Consecutively numbered sealed opaque envelopes. |
| Participants |
27 women at 28‐42 weeks with severe PE (BP 150 mmHg or more, 2/3+ protein), and 1 or more of epigastric pain, convulsions, headache. No chronic hypertension, or renal or cardiac disease. |
| Interventions |
Hydralazine: 5 mg IV. Repeated every 20 min if DBP 110 mmHg or more, max x 3. If BP not controlled, chlorpromazine 12.5 mg IV plus 12.5 mg IM x 2.
Nifedipine: 10 mg sl. Repeated every 20 min if DBP 110 mmHg or more, max x 3. If BP not controlled, chlorpromazine 12.5 mg IV plus 12.5 mg IM x 2. |
| Outcomes |
Woman: control of BP, days in hospital (mean).
Baby: Apgar at 1 and 5 min (mean). |
| Notes |
All women had a diazepam infusion for 24 hr after delivery. Data not included in analysis. Mean hospital stay (days): for nifedipine n = 13, 5.5 SD [2.1] and for hydralazine n = 14, 6.0 [2.2]. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
“The process of randomisation was carried out using numbered permutation blocks of 6; using a table of random numbers ....” |
| Allocation concealment (selection bias) |
Low risk |
A ‐ Adequate. “..the blocks were selected and the allocation sealed in opaque envelopes and numbered progressive order.” |
| Blinding of participants and personnel (performance bias)
All outcomes |
High risk |
Not reported, but regimens different. |
| Blinding of outcome assessment (detection bias)
All outcomes |
High risk |
Not reported, but regimens different. |
| Incomplete outcome data (attrition bias)
All outcomes |
Unclear risk |
Unclear, article in Spanish and can not tell from translation. |
| Selective reporting (reporting bias) |
Unclear risk |
Unclear, article in Spanish and can not tell from translation. |
| Other bias |
Unclear risk |
Unclear, article in Spanish and can not tell from translation. |
