Methods | RCT 2-arm parallel group design. | |
Participants | Setting: UK hospital. 100 women in labour at term gestation with uncomplicated pregnancy |
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Interventions | Experimental: Meptazinol 1.8 mg/kg body weight (N = 50). Control: pethidine 1.8 mg/kg body weight (N = 50). All participants received promethazine 12.5 mg with first injection |
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Outcomes | Primary: newborn effects: Apgar score at 1 and 3 min. | |
Notes | If additional analgesia required, a repeat injection could be administered 3 hourly 6/50 women from each arm received a second dose at a 3-hourly interval | |
Risk of bias | ||
Bias | Authors’ judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not reported. |
Allocation concealment (selection bias) | Unclear risk | Not reported. |
Blinding (performance bias and detection bias) Women |
Unclear risk | States double blind but method not described. |
Blinding (performance bias and detection bias) Clinical staff |
Unclear risk | States double blind but method not described. |
Blinding (performance bias and detection bias) Outcome assessor |
Unclear risk | States double blind but method not described. |
Incomplete outcome data (attrition bias) All outcomes |
High risk | 5 babies excluded from analysis due to heart defects and fetal distress |
Selective reporting (reporting bias) | Unclear risk | Unclear. |
Other bias | Unclear risk | Balanced for parity, weight and size of baby at baseline. |