Methods | RCT. | |
Participants | 70 women in established labour admitted to a hospital in Norway for delivery Inclusion criteria: cervical dilation 4 cm or more, expected to have normal birth, at term after a normal pregnancy |
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Interventions | Intervention group: TENS to lower back. Comparison group: placebo TENS of identical appearance. Conventional drugs available to both groups. |
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Outcomes | Women’s views of pain relief and use of other analgesics. | |
Notes | ||
Risk of bias | ||
Bias | Authors’ judgement | Support for judgement |
Random sequence generation (selection bias) | High risk | Not described. |
Allocation concealment (selection bias) | High risk | Coin tossed after recruitment to decide group allocation. |
Blinding (performance bias and detection bias) Participants |
Unclear risk | Placebo device, but not clear whether it was convincing to women and staff |
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 | No apparent loss to follow up. |
Other bias | Unclear risk | Some baseline imbalance between groups with more primiparous women in the intervention group |