France 1987.
Methods | Allocation concealment: quote "blinded envelopes". Stratified in blocks of 10 at each clinic. Multicentre, 12 hospitals. Withdrawals: 12 women (6%). 5 labetalol (3 lost to follow‐up and 2 given methyldopa) and 7 methyldopa (all lost to follow‐up). Two arms | |
Participants | 188 women with singleton pregnancy at 12 to 34 weeks' gestation, booked < 20 weeks and DBP >/= 90 mmHg. Excluded: previous antihypertensive treatment this pregnancy, diabetes, depression, contraindication to beta blockers. | |
Interventions | Exp: oral labetalol 200 mg x 2/day to 600 mg x 2/day. (96 women) Control: oral methyldopa 250 mg x 2/day to 750 mg x 2/day. (92 women) | |
Outcomes | Women: proteinuria (> 2+ or 0.5 g/L), admission to hospital, caesarean section, elective delivery, additional antihypertensive, side‐effects, changed drugs due to side‐effects. Babies: stillbirth, neonatal death, admission to SCBU, SGA (< 5th centile, excludes stillbirths), preterm delivery (< 37 weeks), 5 mins Apgar < 8. | |
Notes | Korotkoff phase IV used for DBP. Funding: funded by industry. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "...stratified blocks of ten at each clinic..." |
Allocation concealment (selection bias) | Low risk | Blinded envelopes. |
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 | Low risk | 12 women (6.4%) excluded from analysis: 10 lost to follow‐up (3 from labetalol and 7 from methyldopa group), and 2 quote: "protocol violation". |
Selective reporting (reporting bias) | Unclear risk | Assessment from published study report. |
Other bias | High risk | Groups appear comparable at baseline. Funded by industry. |