Ajori 2013.
Methods | 80 women randomised to either verum (n = 40) or sham (n = 40) acupuncture | |
Participants | 80 women with gestational age between 38 and 42 weeks presenting to Tajrish Hospital in Tehran, Iran. Women were included if they had cephalic presentation, cervical dilatation less than 3 cm, intact membrane, and no signs of labour. Women were excluded if they had previous caesarean section or incision of the uterus, multiple pregnancy, malformation of pelvis, skin infections, anticoagulant drug use, psychological disorders, previous inability to tolerate acupuncture, intrauterine growth restriction, suspected macrosomia, indications of emergency termination of pregnancy by induction or caesarean section before onset of labour as described by the American College of Obstetricians and Gynecologists (ACOG), and request of elective termination of pregnancy before 42 weeks of gestation. | |
Interventions | True acupuncture points included which were located on the Spleen 6 (on the inner ankle), Large intestine 4 (in the webbing between thumb and forefinger) and Bladder 67 (on the outer edge of the little toe), and needles were advanced or manipulated until ‘de qi’ was stimulated. Needles were inserted at all points bilaterally and retained for 30 minutes for both groups. Manual stimulation was provided during the time. The procedure was administered up to a maximum of 2 times over a 1‐week period (every 3 days) and routine prenatal care was continued. Sham acupuncture points included non‐acupuncture points in the hands and legs, and insertion was shallow. |
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Outcomes | The primary outcome was initiation of labour, defined as active labour (3 contractions in 10‐minute interval with cervical dilatation 4 to 5 cm) or rupture of membranes. The time from entry (first acupuncture treatment) to delivery, mode of delivery, fetal and maternal outcome, and Apgar scores at 1 and 5 minutes were recorded. | |
Notes | Study duration 2010 to 2011 Funding: not reported Conflicts of Interest: none |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated random numbers used. |
Allocation concealment (selection bias) | Low risk | Allocation concealed within sealed envelopes. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Participants blinded. Acupuncturist not blinded however this should not have influenced the outcome measures recorded. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Both outcome assessor and statistician were blinded as to randomisation. All the participants were evaluated for outcomes by 1 gynaecologist. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Dropout rate low, 2 women discontinued in the verum group, 3 women in the sham group, therefore similar across both groups with no group‐specific differences in the reason for dropout. |
Selective reporting (reporting bias) | Low risk | No study protocol published but prospective trial registration showed all outcomes were reported. |
Other bias | Unclear risk | Insufficent reporting to judge. |