Tremeau 1992.
Methods | Randomised controlled trial examining the effect of acupuncture on cervical maturation. Parallel design of acupuncture versus usual care and sham acupuncture. | |
Participants | 128 women met the entry criteria and were randomised. Participants were recruited from a maternity hospital in France. Women were 37 to 38 weeks pregnant with a Bishop's score of less than 4. Exclusion criteria included: at risk of premature delivery, planned caesarean section, placenta previa, and receiving concurrent treatments such as yoga, homeopathy, acupuncture. | |
Interventions | Acupuncture points were selected based on those used to increase cervical maturation including: CV2, CV3, CV4, Liv3, BL60, GB34, ST36, LI4, SP6, BL67. The acupuncture control was pricked with needles at sites 1 cm from the bilateral acupoint, and 1 cm from the mid‐line points, and a third group received usual care. 3 treatment sessions were administered, with electro‐stimulation for 20 minutes. |
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Outcomes | The Bishop's score was assessed 48 hours after the last acupuncture session, duration of labour, and time to 2 cm cervical dilatation. | |
Notes | Study duration 1st February to 30th October 1990 Funding: not reported Conflicts of Interest: not reported |
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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 of participants and personnel (performance bias) All outcomes | Unclear risk | No details were reported on whether the integrity of blinding between acupuncture and the sham group was maintained. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | The outcome assessment was undertaken by a clinician blind to group. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | 16% of women did not complete the protocol due to spontaneous labour before the second examination, 2 women declined the second examination, and 1 woman did not return for acupuncture. |
Selective reporting (reporting bias) | Unclear risk | Limited reporting and unable to assess. |
Other bias | Low risk | No imbalance in baseline characteristics. |
ACOG:American College of Obstetricians and Gynecologists AIDS: Acquired Immune Deficiency Syndrome CTG: Cardiotocography DAU: Day Assessment Unit EDC: estimated date of confinement HIV: Human Immunodeficiency min: Minute NICU: Neonatal Intensive Care NST: Non Stress Test NVD: Normal Vaginal Delivery pH: potentia hydrogenii PROM: premature rupture of membranes TCM: traditional Chinese medicine TENS: transcutaneous nerve stimulation