Methods | RCT 2-arm parallel group design. | |
Participants | Stockholm Sweden, hospital setting. 20 healthy nulliparous women in active labour after spontaneous rupture of the membranes, cephalic presentation. No exclusion criteria specified |
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Interventions | Experimental: 0.05 mg/kg IV morphine up to 3 doses (max 0.15 mg/kg body weight) Control: 0.5 mg/kg IV pethidine up to 3 doses (max 1.5 mg/kg body weight) Both groups had continuous FHR monitoring. |
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Outcomes | Sedation rates; CS, nausea and vomiting. | |
Notes | ||
Risk of bias | ||
Bias | Authors’ judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | “assigned at random.” |
Allocation concealment (selection bias) | Low risk | Coded ampoules provided by pharmacy. |
Blinding (performance bias and detection bias) Women |
Low risk | Described as double blind; pharmacy provided identical coded ampoules |
Blinding (performance bias and detection bias) Clinical staff |
Low risk | Described as double blind; pharmacy provided identical coded ampoules |
Blinding (performance bias and detection bias) Outcome assessor |
Unclear risk | Unclear. |
Incomplete outcome data (attrition bias) All outcomes |
Low risk | No apparent loss to follow-up. |
Selective reporting (reporting bias) | Unclear risk | Unclear. |
Other bias | Unclear risk | Small sample and no clear information that groups were comparable at baseline. Range of cervical dilations at recruitment between 4 and 9 cm |