Methods | RCT, 2-arm parallel groups. | |
Participants | Setting: UK hospital. 46 women (20 primiparous and 14 multiparous women included in the analyses). Uncomplicated pregnancy Exclusions: first stage of labour > 12 hr, second stage > 1 hr, body weight <45 kg, multiple pregnancy, non-vertex presentation, preterm or postmature labour, previous caesarean section, birth weight outside the 5th and 95th centiles for gestational age, congenital fetal abnormality |
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Interventions | Experimental: IM meptazinol 1.5 mg/kg body weight plus 10 mg metoclopramide hydrochloride (N = 17) Control: IM pethidine 1.5 mg/kg body weight plus 10 mg metoclopramide hydrochloride (N = 17) |
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Outcomes | Neonatal acid-base balance. Maternal pH pre injection, repeated at head crowning, neonatal pH at 10 and 60 min PN | |
Notes | If additional analgesia required opioid repeated > 3 hrly. Actual dose received by women not reported | |
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 not described. |
Blinding (performance bias and detection bias) Clinical staff |
Unclear risk | States double blind but not described. |
Blinding (performance bias and detection bias) Outcome assessor |
Unclear risk | States double blind but not described. |
Incomplete outcome data (attrition bias) All outcomes |
High risk | 12 women excluded from analysis, reasons for all exclusions not explained |
Selective reporting (reporting bias) | High risk | Reasons why some participant data excluded not explained. 3/12 excluded because problem with pH analyser (meptazinol group) |
Other bias | Low risk | No baseline imbalances. |