Brazil 2000a.
| Methods | Allocation concealment: trial drug supplied by pharmacy in packs with serial numbers. Withdrawals: 15 women (7.5%) excluded from the analysis (5 delivered in other hospitals, 9 dropped out of the study or failed to comply with treatment, 1 due to side‐effects). Two arms | |
| Participants | 199 singleton pregnant women with mild/moderate chronic HT (DBP > 90 mmHg and =/< 110 mmHg before 20 weeks' gestation, or with history of chronic HT), before 25 weeks' gestation and giving informed consent. Excluded: renal, cardiac or hepatic disease, IUGR diagnosed before trial entry, alcohol/drug abuse. | |
| Interventions | Exp: oral verapamil 240 mg x 3/day. (90 women) Control: oral placebo. (94 women) | |
| Outcomes | Women: BP, heart rate, severe HT, superimposed PE, side‐effects, mode of delivery. Babies: birthweight, gestational age, SGA, Apgar score, jaundice, hypoglycaemia, mortality. | |
| Notes | Korotkoff phase IV used for DBP. Main report in Portuguese, presented as a Doctoral Thesis. Additional data provided by authors. Funding: no information about funding source. Declaration of interests not described. |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Not described. |
| Allocation concealment (selection bias) | Low risk | Consecutive numbered treatment packs containing the study drug or placebo. |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Double‐blind, only pharmacist providing treatment packs aware of the codes. |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Double‐blind, only pharmacist providing treatment packs aware of the codes. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | 15 withdrawals (7.5%): 5 women delivered in other hospitals, 10 withdrew consent (1 due to side‐effects). |
| Selective reporting (reporting bias) | Unclear risk | Assessment from published study thesis. |
| Other bias | Unclear risk | Groups appear comparable at baseline. No information about funding source. Declaration of interests not described. |