Methods | RCT. | |
Participants | 40 women attending a Boston (USA) hospital. Inclusion criteria: women in active, spontaneous labour with singleton, vertex, term pregnancy, requesting epidural. Cervical dilatation less than 5 cm on recruitment |
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Interventions | All women had a Bupivacaine epidural. Intervention: TENS to lower back. Comparison Group: placebo/inactive TENS. |
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Outcomes | VAS pain scores, use of oxytocin, fetal heart rate, Apgar scores and maternal side effects | |
Notes | ||
Risk of bias | ||
Bias | Authors’ judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | No information provided. |
Allocation concealment (selection bias) | Low risk | “Sequentially numbered, opaque, shuffled envelopes”. |
Blinding (performance bias and detection bias) Participants |
Unclear risk | Described as double-blind trial. TENS machines were in pouches so women could not see if they were on or off |
Blinding (performance bias and detection bias) Clinical staff |
Unclear risk | Unclear. |
Blinding (performance bias and detection bias) Outcome assessor |
Unclear risk | Unclear. |
Incomplete outcome data (attrition bias) All outcomes |
Low risk | All women included in the analysis. |
Other bias | Unclear risk | Some baseline differences, 7/20 women in the intervention group and 3/20 in the control group had opiate analgesia before entry to the study |