Borup 2009.
Methods | Randomised trial of acupuncture, TENS or traditional analgesics. | |
Participants | 607 healthy, Danish‐speaking women in labour with a normal singleton pregnancy who were giving birth at term (37‐42 completed weeks) and with a fetus in cephalic presentation were eligible for the study. Women were recruited from a university hospital. Women were excluded if they had medical complications, or already received analgesics in labour. | |
Interventions | Acupuncture group: acupuncture was administered by midwives who had completed a 5‐day course in Western techniques of obstetric acupuncture, and received at least 6 months' clinical training using acupuncture during labour. Treatment was individualised, according to location of pain and woman’s mobility, needles used of 3 depths 0.20 mm x 15 mm, 0.30 mm x 30 mm, 0.35 mm x 50 mm. Duration of needling 30‐120 minutes and could be repeated. Needles removed if woman uncomfortable or if obstetric pathology. Supplementary analgesics provided on request as per control group. Acupuncture points included BL 23, 24, 25, 26, 31‐34, 36, 60, CV20 and sishongong, ear points uterus, shenmen, endocrine, EX‐HN3 yintang, LR3, SP6, SP9, ST36, GB34, HT7, PC6, LI10,11, LU7, LI 4. Control group: traditional analgesics: women randomised to the traditional group could choose among all analgesic methods available (sterile water papules, nitrous oxide, warm tub bath, pethidine, and epidural analgesia). |
|
Outcomes | Need for pharmacological pain relief, pain intensity, overall experience and satisfaction, duration of labour, use of oxytocin, mode of birth, postpartum haemorrhage, Apgar score, umbilical cord pH. | |
Notes | Study duration: 1 March 2002 to 29 February 2004. Conflicts of interest: none stated. Employment declared in public health and research institutions. Funding: study sponsored by the Asse and Ejnar Danielsen's Foundation, Kgs, Lyngby, Dnemark; Knowledge and Research Cener for Alternative medicine, Aarhus, Denmark; Sophus Jacobsen Foundation, Capenhagen, Denmar; The Danish Midwifery Organisation, Copenhangen, Denmark; Lundbeck Foundation, Copenhagen, Denmark; Mads Clausens Foundation, Nordborg, Denmark; Hede Nielsen Foundation, Horsens, Denmark; The Research Fund at Aarhus University Hosptial, Aarhus, Denmark; Else and Mogens Wedell‐Wedellsborgs Foundation, Copenhagen, Denmark; and King Christian the 10th Foundation, Copenhagen, Denmark. Setting: maternity hospital. Country: Denmark. |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated sequence, with randomisation in a ratio of 2:1. |
Allocation concealment (selection bias) | Low risk | Central randomisation voice response. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Women, midwife acupuncturists were not blinded to their group allocation. Interventions were substantially different and obvious to an observer. |
Blinding of outcome assessment (detection bias) All outcomes | High risk | It was unclear if the outcome assessor or analyst was blinded to group allocation. Outcomes would be recorded by staff providing care who would be aware of the intervention. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Data were missing from 8%, with the reasons similar between groups: no project midwife available, did not want the allocated treatment, rapid progression of labour, other reasons. |
Selective reporting (reporting bias) | Unclear risk | The study protocol is not available but the study reports the expected outcomes. |
Other bias | Low risk | The study appears free of other biases. |