Gaudet 2008.
Methods | 16 participants were randomised to receive either true acupuncture or sham acupuncture. | |
Participants | The study took place in an obstetrics clinics in Canada. Women who were 39 + 0 and 40 + 3 weeks' gestation were approached. Inclusion criteria included nulliparity, an uncomplicated singleton gestation, provision of informed consent, a Bishop’s score of < 7 prior to randomisation, and reassuring fetal status. All interested participants underwent a digital cervical examination by the research nurse prior to randomisation in order to determine the Bishop’s score. If the Bishop’s score was < 7, participants underwent an ultrasound to complete a biophysical profile and an amniotic fluid index. Participants were randomised if they had a biophysical profile score of 8/8 and a normal amniotic fluid index. | |
Interventions | 2 appointments for acupuncture sessions were arranged, the first within 2 to 3 days, and the second within 1 week, with an accredited physiotherapist acupuncturist. The true acupuncture group received electro‐acupuncture at SP6, ST43 and UB60 with manual stimulation of LI4. Participants received electro‐stimulation on 4 points at 1‐2 Hz for 30 to 45 minutes. The sham acupuncture group received acupuncture at sites adjacent to the acupuncture sites. These were not known to have an effect on initiation of labour or to be located on actual acupuncture meridians. The sites used were SP6+, LI4+, ST43+, BL60+ and GB36+. The locations were SP6+: above the anterior ankle joint line slightly lateral to the border of the tibia, LI4+: in the centre of the anatomical snuff box (located between the 1st and 2nd metacarpal bones), ST43+: at the joint line of the ankle superior to the web space of the 3rd and 4th metatarsal bones, BL60+: inferior and posterior to the fibula head, and GB36+: also inferior and posterior to the fibula head. Sham sites were stimulated in the same order as the true acupuncture sites. Electro‐stimulation was applied as in the treatment group. Both groups were instructed in acupressure and encouraged to apply acupressure every few hours for approximately 3 to 5 minutes, at the most important sites (LI4 and SP6, or corresponding sham sites). |
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Outcomes | The primary outcome was time from first acupuncture treatment to delivery. Secondary outcomes included the need for standard methods for induction of labour, duration of active labour, the need for standard pain relief, and the incidence of non‐reassuring fetal heart rate in labour. | |
Notes | Intention‐to‐treat analysis conducted. Study duration February 2004 to October 2005 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) | Low risk | Randomisation was performed using a table of random numbers. |
Allocation concealment (selection bias) | Low risk | Sequentially numbered sealed opaque numbers. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Participants blinded using sham acupuncture, clinicians administering the treatment not able to be blinded but were blinded to all obstetrical parameters. The obstetric care providers were blinded. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | The trial researchers were blinded. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No participants lost. |
Selective reporting (reporting bias) | Unclear risk | No study protocol available. |
Other bias | Low risk | No difference in baseline characteristics. |