Netherlands 1989.
Methods | Coded packages containing trial drug allocated according to a randomisation list. | |
Participants | 10 primigravid women with chronic hypertension and a positive angiotensin II sensitivity test at 26 weeks' gestation. No proteinuria, BP < 90 mmHg diastolic, serum creatinine < 70 umol/L and an adequately grown fetus. | |
Interventions | Exp: aspirin 60 mg. Control: placebo. | |
Outcomes | Women: GH (rise in DBP of 20 mmHg or more); PE (hypertension as before plus proteinuria >/= 500 mg/L); caesarean section. Babies: birthweight < 10th centile. | |
Notes | All women had methyl dopa. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Randomisation list |
Allocation concealment (selection bias) | Unclear risk | Coded packs of tablets, no further information available. |
Blinding (performance bias and detection bias) All outcomes | Low risk | Quote: "placebo‐controlled double‐blind" |
Incomplete outcome data (attrition bias) All outcomes | Low risk | It appears that all 10 patients were successfully followed up. |
Selective reporting (reporting bias) | Low risk | Protocol not available, however it appears that all expected outcomes were reported. |
Other bias | Unclear risk | Information on baseline characteristics not presented and compared for all participants. Small sample size. |