He 2002.
Methods | Randomisation by computer. No blinding. No mention of power calculation or intention‐to‐treat analysis. | |
Participants | China. 60 pregnant women in preterm labour (defined as contracting every 5‐10 minutes lasting 30 seconds with cervix more than 2 cm dilated) between 28 and 37 weeks with intact membranes. No comment on multiple pregnancies. Not blinded. No power calculation mentioned and no intention‐to‐treat analysis mentioned. | |
Interventions | 1. GTN patch 5 mg/24 hrs with another patch added every hr until contractions stopped or 25 mg maximum dose reached. Patches changed every 24 hrs (n = 30). 2. Magnesium sulphate and salbutamol, no doses stated (n = 30). |
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Outcomes | Percentage of women in whom contractions stopped, days delay of labour, pre and post‐treatment corticotrophin releasing hormone levels. | |
Notes | No information on whether women got steroids and/or antibiotic therapy. Translated by Cochrane. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated sequence. |
Allocation concealment (selection bias) | Unclear risk | Not described. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | No blinding. |
Blinding of outcome assessment (detection bias) All outcomes | High risk | No blinding. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Insufficient reporting of attrition and exclusions to permit judgement, e.g. number randomised not stated or no reasons for missing data provided. |
Selective reporting (reporting bias) | Unclear risk | Insufficient information to permit a judgement. |
Other bias | Unclear risk | Not addressed in translation. |