Andersen 2013.
Methods | 407 women were randomly assigned to acupuncture (n = 100), acupuncture + sweeping of fetal membranes (n = 103), sweeping of fetal membranes (n = 100) or usual care (n = 100). | |
Participants | 407 women at 41 + 2 to 41 + 4 weeks gestational age, presenting at Hvidovre University Hospital, Odense University Hospital, Odense, and Roskilde University Hospital, Roskilde, Denmark, from 1 January 2007 to 31 November 2009. Women were included if they had an uncomplicated spontaneous singleton pregnancy, a cephalic presentation, intact fetal membranes, and with Danish spoken. Women were excluded if they had used any kind of acupuncture or had sweeping of the fetal membranes within the last 2 weeks. | |
Interventions | All active groups received usual routine care along with CTG monitoring. The women in the active groups were treated twice during 41 + 3 and 41 + 5 weeks of pregnancy or on the nearest working day. Acupuncture group: the acupuncture needles were placed bilaterally at points LI4, ST36, LR3, BL60, BL31 and BL32. 1 needle was placed at GV20 and 2 needles at right SP6. Electrical stimulation was performed at points BL31 and BL32 bilaterally and at right SP6. The needles were left in place for at least 30 min. Stimulation was performed at a frequency of 80 Hz medium. The needles used were Carbo acupuncture needles (Suzhou Sen Sen, SuZhou, Jiangsu, China), 0.30 x 50 mm at BL31 and BL32 and 0.25 × 25 mm at the remaining points. Sweeping of the fetal membranes was performed by circulating the fingers 3 times between the lower membranes and their attachment to the cervix, separating membranes and the cervix as much as possible. If membrane sweeping was not possible because of a closed cervix, cervical massage was performed by moving the cervix in relation to the pregnancy. The women in the usual care group received the usual CTG during week 41 + 3. |
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Outcomes | Spontanous labour, type of delivery (NVD, caesarean section), blood loss, oxytocin augmentation, epidural rate, neonatal outcomes: Apgar score < 7 and NICU admission. | |
Notes | Acupuncture + sweeping of membranes group was not eligible for comparison in this review. Study duration 1 January 2007 to 30 November 2009 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 | Telephone‐based computer‐randomisation system used. |
Allocation concealment (selection bias) | Low risk | Central randomisation via telephone system. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Not possible for participants to be blinded, however this was unlikely to affect primary or secondary outcome measures. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | The midwives, completing the assessment forms for the trial at labour or induction, were blinded to group allocation. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Dropout rates low (< 5%). Dropout rates not defined between groups, however no evidence of a difference between groups for declining to proceed with intervention. |
Selective reporting (reporting bias) | Unclear risk | No study protocol or prospective trial registration provided. |
Other bias | Low risk | Sample size calculation provided and groups balanced at baseline. |