Smith 2008.
Methods | Randomised controlled trial of acupuncture versus sham acupuncture sessions to estimate the effectiveness of acupuncture to induce labour. | |
Participants | The study took place in a Women's and Children's Hospital in Australia between 1998 and 2005. 364 women aged greater than 16 years with a singleton pregnancy and cephalic presentation scheduled for a post‐term induction were recruited to the study. Women were excluded if they were in active labour with regular uterine contractions, if there were contraindications to labour or vaginal birth, or if they presented with spontaneous pre‐labour rupture of membranes. | |
Interventions | The acupuncture group received acupuncture at LI4, SP6, UB31, UB32, ST36, and LR3. Any underlying pathology from a TCM framework was examined and treated with additional points, e.g. KI7, UB20, UB21, LR3. Needles were retained for 30 to 40 minutes with strong stimulation and de qi. Seirin 1‐2 inch needles were used with a 32 gauge (0.25 mm) diameter. The sham group received the same treatment in terms of timing and duration, but with minimal insertion and stimulation. Sham points were selected on the sacral area, hand, foot, a point below the knee, and lower leg, at points that were not acupuncture points. Treatments were administered over a 2‐day period before the planned induction. |
|
Outcomes | The primary outcome was the need for induction, a reduction in the need for prostaglandins, oxytocin, and artificial rupture of membranes, change in Bishop's score, time of intervention to time of delivery, and length of active labour. Secondary: methods of pain relief, mode of birth, Apgar scores less than 7 at 5 minutes, admission of the mother and neonate from the labour ward to the postnatal ward together, meconium, nonreassuring fetal heart rate tracing, neonatal jaundice requiring phototherapy, neonatal seizures, acceptability of treatment by the mother, Bishop's score, labour agentry scale of control in childbirth, likes and dislikes regarding participation in the trial. |
|
Notes | Intention‐to‐treat analysis was conducted. Sample size calculation reported. Study duration May 1998 to February 2005 Funding: Australian National Health and Medical Research Council, the Women’s and Children’s Hospital Foundation, Adelaide, Australia. Conflicts of Interest: not reported |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | A computer‐generated randomisation schedule created by an independent statistician in variable block size and stratified by parity (nulliparous and multiparous) and incorporated into a telephone randomisation service. |
Allocation concealment (selection bias) | Low risk | A central telephone randomisation service was available 7 days a week at the recruiting hospital. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Participants were blinded to allocation by use of sham control. Caregivers were blind to the women's study group. The treatment allocation was known only to the acupuncturist administering the intervention. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Data collection was done by someone not involved in the administration of the intervention and the analyst was blind until the end of data analysis. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All participants received at least 1 session in both groups, 11 participants in the acupuncture group received only 1 treatment and 15 women in the sham acupuncture group. Reasons given were problems with childcare, feeling too tired, and lack of transportation to the trial centre. All participants were included in the analysis. |
Selective reporting (reporting bias) | Low risk | All outcomes reported as per trial registration. |
Other bias | Low risk | Women in the sham group were older and there were also differences in the categorisation of the Bishop's score. The authors adjusted the primary outcomes for maternal age and the raw Bishop's score. |