India 2013a.
Methods | Allocation concealment: not described, quote: "...prospective randomized study,.." no further details. Two arms | |
Participants | 120 pre‐eclamptic women after 20 weeks of gestation with BP more than 140/90 mmHg on 2 separate occasion 6 hrs apart, proteinuria +1 dipstick in 2 midstream samples collected 4 hrs apart. Singleton with vertex presentation. Excluded: diabetes, Rh isoimmunisation, multi‐fetal pregnancy, thyrotoxicosis, cardiac disease, chronic HT, renal disease, bronchial asthma, antepartum haemorrhage, malnutrition, poli‐hydramnios, already receiving antihypertensive drugs. |
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Interventions | Exp: oral labetalol 100 mg 3 times a day. (90 women) Control: oral methyldopa 250 mg 3 times a day. (90 women) |
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Outcomes | Women: response in lowering BP over a period of 7 days, blood urea and serum creatinine, platelet count, mode of onset of labour, gestational age at delivery, mode of delivery, side‐effects. Babies: birthweight, stillbirth, preterm delivery, Apgar score, RDS, jaundice, bradycardia, hypoglycaemia, need for NICU. |
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Notes | Method for measuring BP not mentioned. 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) | Low risk | Computer‐generated sequence of random numbers. |
Allocation concealment (selection bias) | Unclear risk | Not described. Quote:"...prospective randomized study,.." no further details. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Not described. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not described. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No. |
Selective reporting (reporting bias) | Unclear risk | Assessment from published study report. |
Other bias | Unclear risk | Groups appear comparable at baseline. No information about funding source. Declaration of interests not described. |