Methods |
'Randomised', no further information. 5 women excluded from chlorpromazine group because they received another antihypertensive. CFU ‐ B, blinding C. |
Participants |
60 women with severe PE or eclampsia. Excluded if cardiopathy, diabetes, isoimmunisation, twin pregnancy, or antihypertensive in 48 hr before trial entry. |
Interventions |
Chlorpromazine: 12.5 mg IV and 12.5 mg IM. 12.5 mg IV repeated every 30 min, to a total of 50 mg, until BP controlled or an additional antihypertensive.
Nifedipine: 10 mg sl, repeated every 30 min to a max of 4 doses until BP controlled or an additional antihypertensive. |
Outcomes |
Woman: eclampsia, additional antihypertensive, caesarean section.
Baby: gestation at delivery (mean). |
Notes |
All women received phenytoin. |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Low risk |
“The randomised assignment took place using permutation blocks and random number tables.” |
Allocation concealment (selection bias) |
Unclear risk |
B ‐ Unclear. States “...the scheme for each patient in a sealed envelope identified with a number” ‐ but no information whether envelopes were sequentially numbered or opaque. |
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 |
60 women were randomised, but 5 women in the chlorpromazine group were excluded from the analysis as they received other medications, reducing this group to 25. Don't appear to present any data on these 5 women ‐ though this was from a 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. |