Italy 1999.
Methods | Allocation concealment: consecutive‐numbered, opaque, sealed envelopes. 3‐arm study. 6 women (17%) left the study due to side‐effects (2 women) or mother's or baby's worsening conditions (4). Three arms | |
Participants | 36 women with singleton pregnancy, gestation > 24 weeks and PIH or PE (BP 140/90 mmHg or more, PE if proteinuria > 300 mg/24 hr). Excluded: fetal abnormalities or chromosomal disorders, renal or hepatic disease, chronic HT. | |
Interventions | Exp (1): transdermal GTN 10 mg continuously 24 hr/day (12 women). Exp (2): transdermal GTN 10 mg intermittently for 16 hrs/day.(12 women) Control: oral nifedipine 40 mg/day orally. (12 women) | |
Outcomes | Women: caesarean section, BP (mean), stopped drug due to side‐effects, severe HT, proteinuria/PE. Babies: birthweight, fetal/neonatal deaths, preterm birth, IUGR, gestation at birth (mean). | |
Notes | Korotkoff phase IV used for DBP. In the analysis the 2 GTN arms have been combined. 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 opaque sealed envelopes (personal communication). |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Open‐label trial. |
Blinding of outcome assessment (detection bias) All outcomes | High risk | No. |
Incomplete outcome data (attrition bias) All outcomes | High risk | 6 withdrawals (16.6%). 3 in group 1, 1 in group 2 and 2 in group 3. |
Selective reporting (reporting bias) | Low risk | Additional data provided by authors. |
Other bias | Unclear risk | No information about funding source. Declaration of interests not described. |