Hantoushzadeh 2007.
Methods | Single‐blind randomised controlled trial of acupuncture versus placebo acupuncture using sham needling. Duation: February to September 2005. Setting: government general hospital, Tehran, Iran. |
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Participants | 150 women with a singleton pregnancy, at term (37 weeks), nulliparous, parturient and in spontaneous active labour. Exclusion criteria: presence of medical or surgical disease, indication for caesarean section, pace‐maker, emphysema, history of anticoagulation, HIV, HCV or HBV infection, pregnancy‐related complications, e.g. chorioamnionitis, placental abruption, placenta praevia and pre‐eclampsia/eclampsia, cervical dilation > 6 cm. | |
Interventions | The study group received acupuncture administered by the study investigator, who was trained to practice acupuncture. Points were selected bilaterally according to parturient symptoms, and needles were inserted at 45 degree or perpendicularly with a depth that depended on the thickness of the subcutaneous fat. The selection of points was done according to acupuncture principles and was subject to variation from patient to patient. Needles were manually stimulated until the de chi sensation (sensation of warmth, numbness, tingling, or heaviness) was achieved. The needles were not taped and were removed either when delivery occurred or the patient herself asked to do so or when the effect terminated or there was no effect. The following points and there indication were reported as follows: LI4‐ analgesia, BL32‐back pain, BL60 back pain, SP6 severe pain during contractions, ST36 general pain, LR3 analgesia, GB34 cervical rigidity, HT7 anxiety, nervousness. The control group received minimal acupuncture which involved insertion of acupuncture needles away from true acupuncture points. Participants were not asked about de qi and the needles were manually stimulated for about 20 minutes. Both groups received care from health providers, routine analgesia was not available. |
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Outcomes | Pain scores measured using VAS scale 0‐100, at beginning, 30 minutes, 60 minutes, 120 minutes, then every hour until end of labour. Duration of active labour, amount of oxytocin used, vaginal birth, birthweight, Apgar score at 1 minute, acceptability of acupuncture. |
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Notes | Study duration: February 2005 to September 2005. Funding: Vali Asr Research Centre for Reproductive Health. Conflict of interest: not stated. Setting: maternity hospital. Country: Iran. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer generated. |
Allocation concealment (selection bias) | Low risk | Sealed opaque envelopes. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Partcipants blinded to group allocation (assessment of intact blinding not reported), administering clinician unblinded, care provider unclear. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Outcome assessor blinded. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 5 losses in the acupuncture group: 3 caesarean section, 2 labour stopped. 1 loss in the control group caesarean section. No ITT. |
Selective reporting (reporting bias) | Unclear risk | Protocol not available. |
Other bias | High risk | Partcipants in the control group had significantly lower pain scores before intervention commenced. |