Andersen 2013.
Methods | Randomised controlled trial | |
Participants |
Setting: delivery wards at Hvidovre University Hospital, Odense University Hospital & Roskilde University Hospital, Denmark. Duration of study: 1 January 2007 – 31 November 2009 Inclusion criteria: “Healthy women with an uncomplicated spontaneous singleton pregnancy, a cephalic presentation, intact fetal membranes and with Danish spoken” “pregnancy week 41+2‐41+4”. “whenever an acupuncture certified midwife was available” “Gestational ages were estimated using fetometric ultrasound parameters obtained before 22 weeks of gestation”. Page 556 Exclusion criteria: “Women treated with any kind of acupuncture and women treated with sweeping of the fetal membranes within the last 2 weeks before the study were excluded”. Page 556 Parity: mixed, both primiparous and multiparous women included in this study Bishop score: median/mean Bishop score recorded |
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Interventions | “Women in the active groups were treated twice during 41+3‐41+5 weeks of pregnancy or on the nearest working day”. “The women in the control group received the usual control with CTG during week 41+3” “certified acupuncturists performed the acupuncture. Experienced midwives performed the sweeping of the fetal membranes” Page 556 Acupuncture (n = 104): acupuncture needles placed bi‐laterally at points LI4 (Augmentation of uterus contractions), ST 36 (Improves strength of the body, immune system and nutrient uptake), LR 3 (calming, reduces pain), BL 60 (augmentation of contractions), BL 31, BL 32, GV 20 (mental calming), SP 6. Electrical stimulation performed at points BL31(has impact on gynaecologic organs), BL 32 (has impact on gynaecologic organs) and SP6 (induction of labour, augmentation of contractions, and has an effect on difficult births combined with LI 4 and LR 3. Needles were left in place for at least 30 minutes. Stimulation was performed at a frequency of 8 0 Hz medium. Page 556 Sweeping (n = 103): “performed by circulating the investigating fingers three 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” Page 556 Acupuncture and sweeping (n = 100): “treated twice during 41+3‐41+5 weeks of pregnancy or on the nearest working day”. Page 556 Control (n = 100): “Usual control with CTG during week 41+3” “In women not delivered by week 42+0, a midwife blinded regarding which group the woman was allocated to induced labour on the nearest working day” page 556 |
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Outcomes | Spontaneous onset of labour Caesarean section Instrumental vaginal delivery Epidural analgesia PPH (as defined by the trial authors) Apgar score less than 7 at 5 minutes Augmentation pH < 7.05 |
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Notes |
Trial authors’ declaration of interest: none declared Funding: not reported Consent: “written consent” given. page 556 Ethical approval: “Danish Scientific Ethical Committee approved the research” Page 556 Email with request for further information sent 28 July 2017. Resent 20 September 2017. No reply to date. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | “computer‐randomization system accessible through a telephone line (voice response)” Page 556 “two women were not randomised because of difficulties with the telephone connection to the computer randomisation system” Page 556 |
Allocation concealment (selection bias) | Low risk | “computer‐randomization system accessible through a telephone line (voice response)” Page 556 |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Participants: “Randomization was performed just before (the same day) the treatment was initiated” “Treatment could not be hidden from the pregnant women” Page 556 Personnel: allocation only blinded to midwife performing induction of labour if woman not in spontaneous labour at 42+0 weeks' gestation. “However women “occasionally might have told the midwife” their allocated group. Page 556. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not reported. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No evidence of attrition bias. 10 women were excluded post randomisation. “4 women declined further participation when informed of group” N = 4 women discontinued (n = 3) or did not receive (n = 1) intervention because of staff shortages, page 556. < 20% |
Selective reporting (reporting bias) | Low risk | No evidence of selective reporting bias. No protocol available. |
Other bias | Low risk | No protocol available.N = 4 women discontinued (n = 3) or did not receive (n = 1) intervention because of staff shortages, page 556. |