Methods | RCT with block randomisation. | |
Participants | Setting: outpatient clinic in North Carolina USA. 56 women randomised Inclusion criteria: primiparous women at term (39 weeks and 4 days to 41 weeks) with singleton, cephalic, pregnancy and Bishop score < 7 Exclusion criteria: cannot tolerate acupuncture, uncertain dates, breech presentation, placenta praevia, contraindication to vaginal delivery |
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Interventions | Cervical examination and ultrasound at recruitment. Intervention group: acupuncture + routine care on 3 of 4 consecutive days, visits also included fetal monitoring, treatment by trained acupuncturist to hands, legs and lower back and low voltage stimulation Comparison group: routine care with follow up after 3 or 4 days |
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Outcomes | Vaginal delivery not achieved in 24 hrs, additional induction agents required. CS, mean time to delivery | |
Notes | ||
Risk of bias | ||
Item | Authors’ judgement | Description |
Adequate sequence generation? | Yes | Computer generated sequence in balanced blocks of 2 or 4. |
Allocation concealment? | Yes | Sealed, opaque, sequentially numbered envelopes. |
Blinding? Women |
No | Blinding not feasible. |
Blinding? Clinical staff |
No | |
Blinding? Outcome assessor |
No | |
Incomplete outcome data addressed? All outcomes |
Unclear | Data were available for all women randomised but denominators were not clear for some outcomes |
Free of other bias? | Unclear | Women receiving acupuncture attended for 3 additional visits where other interventions occurred as well as acupuncture that may have affected outcomes |