Vixner 2014.
Methods | 3‐armed, randomised controlled trial. | |
Participants | 303 nulliparas, normal singleton pregnancies, cephalic presentation, 37 + 0 to 41 + 6 gestational age, expressed need for labour pain relief, admitted to delivery ward in active or latent phase of labour, spontaneous onset of labour. Sufficient Swedish for consent. | |
Interventions | 1. Manual acupuncture: MA group ‐ needles were inserted and stimulated manually until DeQi achieved and thereafter stimulated at 10‐minute intervals. 2. Electro‐acupuncture: EA group, needles were inserted and first stimulated manually until DeQi achieved, then 8 of the local needles were connected to an electrical stimulator which was set at a high frequency (80 Hz) stimulation. The decision regarding which local needles were to be connected to the stimulator was made by the midwife. The woman adjusted the intensity of the electrical stimulation herself to a level just under the pain threshold. The remaining needles were stimulated manually every ten minutes by the midwife until DeQi was achieved. The women in the EA group received a combination of electrical and manual stimulation. MA or EA treatment was repeated after 2 hours, and thereafter made available on request. After the first treatment with acupuncture, women in the MA end EA groups had access to all the other pharmacological and non‐pharmacological methods of pain relief available on the delivery wards. After randomisation and when requesting pain relief, women in the MA and EA groups were treated with 13–21 needles, at 3 bilateral distal points and 4–8 bilateral local points, all within the same somatic area as the cervix and uterus. The local points were chosen with regard to the pain location. The needles were removed after 40 minutes. 3. Control group: usual care: women had access to all forms of pain relief with the exception of acupuncture, and the choice of which pain relief that was used was made by the woman and the midwife together. Pain relief included pharmacological analgesia (NO2, EDB, morphine), SWI, TENS. |
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Outcomes | Outcomes: primary: women’s self‐assessment of labour pain. Secondary: experience of relaxation, use of epidural analgesia, satisfaction with pain relief. Outcomes reported in trial design paper also include: labour outcomes: mode of birth, pain relief, augmentation of labour, duration of labour and perineal trauma. Negative side effects, experience of midwife support, pro‐inflammatory cytokines (IL‐1, IL‐6, hs‐CRP, TNF‐alpha). Memory of labour and pain and overall childbirth experience. Infant outcomes: Apgar score, pH, BE, neonatal transfer. |
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Notes | Study duration: November 2008 to October 2011. Funding: funded by grants from the Centre for Clinical Research Dalarna, Karolinska Institutet, Uppsala‐Örebro Regional Research Council, University of Skövde, FOU Fyrbodal, Magnus Bergvall. Stiftelse, and Dalarna University, Sweden. Conflict of interest: authors state there are no conflicts of interest. Setting: delivery wards at 2 Swedish hospitals. Country: Sweden. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated randomisation sequence. The randomisation was conducted in blocks with the length of 9, 12 and 15 which varied randomly. |
Allocation concealment (selection bias) | Low risk | Opaque sealed envelopes. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | No blinding. |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Not blinded. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | MA group: 99 randomised – 16 did not receive MA; 19 did not receive MA according to study design (3 did not fulfilled inclusion criteria; 13 received < 7 needles; 9 had Rx < 40 minutes). N = 64 received MA according to study design. EA group: 103 randomised ‐ 16 did not receive EA; 35 did not receive MA according to study design (5 did not fulfilled inclusion criteria; 14 received < 7 needles; 16 had Rx < 40 minutes). N = 52 received MA according to study design. SC group: 101 randomised ‐ 18 did not receive SC; 8 did not receive SC according to study design (8 did not fulfilled inclusion criteria). N = 75 received SC according to study design MA group: ITT n = 83; PP n = 64 EA group: ITT n = 87; PP n = 52 SC group: ITT n = 83; PP n = 75 |
Selective reporting (reporting bias) | Low risk | Trial protocol published. Some outcomes on blood sampling not reported. |
Other bias | Unclear risk | No baseline imbalances. |
APG: acupressure group ITT: intention to treat LMP: last menstrual period SCG: standard care group SWI: sterile water injections TENS: transcutaneous electrical nerve stimulation TG: touch group VAS: visual analogue scale