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Acupuncture for induction of labour

  1. Caroline A Smith1,*,
  2. Caroline A Crowther2,3,
  3. Suzanne J Grant1

Editorial Group: Cochrane Pregnancy and Childbirth Group

Published Online: 15 AUG 2013

Assessed as up-to-date: 14 DEC 2012

DOI: 10.1002/14651858.CD002962.pub3


How to Cite

Smith CA, Crowther CA, Grant SJ. Acupuncture for induction of labour. Cochrane Database of Systematic Reviews 2013, Issue 8. Art. No.: CD002962. DOI: 10.1002/14651858.CD002962.pub3.

Author Information

  1. 1

    University of Western Sydney, Center for Complementary Medicine Research, Sydney, New South Wales, Australia

  2. 2

    The University of Adelaide, ARCH: Australian Research Centre for Health of Women and Babies, The Robinson Institute, Discipline of Obstetrics and Gynaecology, Adelaide, South Australia, Australia

  3. 3

    The University of Auckland, Liggins Institute, Auckland, New Zealand

*Caroline A Smith, Center for Complementary Medicine Research, University of Western Sydney, Locked Bag 1797, Sydney, New South Wales, 2751, Australia. caroline.smith@uws.edu.au.

Publication History

  1. Publication Status: New search for studies and content updated (conclusions changed)
  2. Published Online: 15 AUG 2013

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Characteristics of included studies [ordered by study ID]
Asher 2009

Methods89 women were randomised to 3 groups true acupuncture (TCM) (n = 30), sham (n = 29), control (n = 30). Sample size was determined by 30 participants per group to provide 80% power to detect a 3-day difference between groups.


ParticipantsThe trial took place at a medical centre in North Carolina, USA. Women included were nulliparous, between 38 and 41 weeks of gestation, able to communicate in English, and at least 18 years old. Exclusion criteria included uncertain dating, transportation difficulties, breech presentation, or a previous inability to tolerate acupuncture.


InterventionsThe true acupuncture group received needles bilaterally at LI4, SP6, UB32, and UB54 alongside routine prenatal care. Needles were manually stimulated until de qi was attained and retained for 30 minutes. Treatments were administered for up to a maximum of 5 treatments over a 2-week period. Acupuncture was performed by 2 licensed acupuncturists. Needles were Seirin J-type (0.16 mm x 30 mm for hand and leg points, 0.24 mm x 40 mm for back points).

The sham acupuncture group received invasive shallow needle insertion at non-acupuncture points on the hands, legs, and lower back, bilaterally, alongside routine prenatal care. Needles were retained for 30 minutes.

Patients enrolled in the true acupuncture or sham acupuncture group received treatment within 30 minutes of enrolment.

The control group received routine prenatal care only.


OutcomesThe primary outcome measure was time from enrolment (first acupuncture treatment) to time of delivery.

Secondary outcomes were rates of inpatient induction for post-term pregnancy, spontaneous rupture of membranes, caesarean section, assisted delivery, chorioamnionitis, endometritis, postpartum haemorrhage or uterine atony, maternal length of stay, intrapartum fetal distress, and neonatal outcomes (e.g. Apgar scores, post-delivery oxygen requirement).


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskComputer-generated numbers using Stata (v8, Statacorp, College Station, TX) in equal blocks of 2 and 4.

Allocation concealment (selection bias)Low riskConsecutively numbered, sealed, manila envelopes containing the study arm assignment were opened by the principal investigator for each participant after all entry criteria were confirmed.

Blinding of participants and personnel (performance bias)
All outcomes
Low riskPrenatal care providers and participants were masked to the treatment arm assignment if they were receiving acupuncture (TCM or sham acupuncture) but not if they were in the usual care group.

Blinding of outcome assessment (detection bias)
All outcomes
Low riskAll charts were reviewed by an investigator who was blinded to treatment arm assignment throughout the data abstraction process.

Incomplete outcome data (attrition bias)
All outcomes
Low risk1 woman in the sham group refused any treatments, 1 woman in the routine care group received acupuncture outside of the study.  All participants were analysed.

Selective reporting (reporting bias)Unclear riskNo study protocol available.

Other biasLow riskNo imbalance at randomisation.

Gaudernack 2006

MethodsSingle-blind, randomised controlled trial of acupuncture versus standard care.


Participants100 Norwegian women were randomised, 48 to the acupuncture group and 52 to the control group. The trial was undertaken in Norway, and included women with a singleton pregnancy, with spontaneous rupture of membranes, cephalic presentation and at term. Women were excluded if contractions were occurring at least every 10 minutes, lasting more than 30 seconds.


InterventionsThe acupuncture intervention included stimulation of acupuncture points LR3, ST36, CV4; in addition, acupuncture points were administered according to the TCM diagnosis. Total of 9 points used. Needles were retained for 20 minutes. Following treatment women left the hospital to await onset of labour.

Women in the control group received conventional medical treatment including prostaglandins and or oxytocin.


OutcomesOxytocin augmentation, use of other induction agents, time from trial intervention to the birth of the baby, epidural analgesia, instrumental vaginal delivery, maternal side-effects (infection), bleeding, tears, birthweight and Apgar score < 7 at 5 minutes.


NotesThere was no power calculation.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskThe trial generated a computer-generated, randomisation schedule.

Allocation concealment (selection bias)Low riskRandomisation was concealed in sealed envelopes. Allocation was undertaken by the midwife.

Blinding of participants and personnel (performance bias)
All outcomes
High riskIt was not feasible for women and therapist to be blind to group allocation.

Blinding of outcome assessment (detection bias)
All outcomes
Low riskIt was unclear if the outcome assessor and analyst were blind to group allocation.

Incomplete outcome data (attrition bias)
All outcomes
Low risk5 women excluded from analysis in the acupuncture group, 1 due to wrong treatment allocation and 4 had caesarean delivery. 4 women were excluded from the control due to caesarean delivery.

Selective reporting (reporting bias)Unclear riskNo study protocol available.

Other biasUnclear riskIntention-to-treat not reported. Baseline characteristics not reported.

Gaudet 2008

Methods16 participants were randomised to receive either true acupuncture or sham acupuncture.


ParticipantsThe 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 patients 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, patients underwent an ultrasound to complete a biophysical profile and an amniotic fluid index. Patients were randomised if they had a biophysical profile score of 8/8 and a normal amniotic fluid index.


Interventions2 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. Patients received electro-stimulation on 4 points at 1-2 Hz for 30-45 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 encourage to apply acupressure every few hours for approximately 3 to 5 minutes, at the most important sites (LI4 and SP6 or corresponding sham sites).


OutcomesThe 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.


NotesIntention-to-treat analysis conducted.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskRandomisation was performed using a table of random numbers.

Allocation concealment (selection bias)Low riskSequentially numbered sealed opaque numbers.

Blinding of participants and personnel (performance bias)
All outcomes
Low riskParticipants 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 riskThe trial researchers were blinded.

Incomplete outcome data (attrition bias)
All outcomes
Low riskNo participants lost.

Selective reporting (reporting bias)Unclear riskNo study protocol available.

Other biasLow riskNo difference in baseline characteristics.

Gribel 2011

Methods72 multiparous or nulliparous pregnant women were randomised to receive either acupuncture or misoprostol.


ParticipantsThe study took place in a maternity hospital in Brazil. Women were included if they had a Bishop score < 7, single cephalic presentation with gestational age confirmed by ultrasound, with normal ranges for reactive cardiotocography, amniotic fluid volume, blood pressure (< 110 and < 160 mmHg), controlled diabetes, and estimated fetal weight. Women with contraindications for vaginal delivery.


InterventionsThe acupuncture group received acupuncture at :LI4, ST36, LR3, SP6, UB23 and UB32. Points were bilaterally electro-stimulated using two distinct frequencies (5 and 50 Hz) that alternated every 7 pulses for 30 minutes. Electro-acupuncture was performed using a (DIAN series # NS AH1405) pulse generator. The electric current intensity was slowly increased until it could be felt by each patient, although without discomfort (30 min) in the ventral (in lied down position with 30_ dorsal elevation) and in the dorsal points (in the sit down position). Stimulation was performed every 7 hours in 1 to up to 3 sessions in a 24 hour period of hospitalisation to all 6 points. Needles were 0.25 x 30. Only 1 physician, with 10 years experience in providing acupuncture to pregnant women, provided the acupuncture.

The control group received misoprostol (25 mg intravaginally; every 6 hours; up to 4 tablets) within 24 hours.


OutcomesPrimary outcome: successful induction of vaginal delivery within 24 hours.

Secondary outcomes: labour induction; induction and labour duration, caesarian section rate; and initial and final Bishop score (defined as the scores at the end of the protocol, or at the beginning of labour). Labour was defined as 2 to 3 30-40 duration, contractions every 10 minutes for more than 60 minutes, with a 2 or 3 cm dilation of cervix in multiparous or nulliparous women, patient satisfaction.


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskComputer-generated, Internet-based block randomisation.

Allocation concealment (selection bias)Low riskSealed envelopes were used.

Blinding of participants and personnel (performance bias)
All outcomes
High riskParticipants and clinicians were not blinded.

Blinding of outcome assessment (detection bias)
All outcomes
Low riskOutcome assessors were blinded (information attained through email correspondence with the author).

Incomplete outcome data (attrition bias)
All outcomes
Low risk3 patients from the misoprostol group were excluded, 2 refused to participate and 1 used a dosage different to the study protocol. 2 patients were excluded from the acupuncture group as they used misoprostol during their hospital stay. These participants excluded after randomisation were not included in the final analysis.

Selective reporting (reporting bias)Unclear riskNo study protocol available.

Other biasLow riskNo imbalance at randomisation.

Harper 2006

MethodsSingle-blind, randomised controlled trial of acupuncture versus standard care. Group assignment was made by the principal investigator after entry criteria were confirmed.


Participants56 women were randomised to the trial. The trial was undertaken in an outpatient clinic at the University of North Carolina, USA. Women were included if they were primiparous, with a Bishops score < 7, between 39 and 4 days to 41 weeks, with a cephalic presentation. Women were excluded if they had a contraindication to vaginal delivery, uncertain dating or an inability to tolerate acupuncture.


InterventionsThe intervention group involved acupuncture administered for 3 out of 4 consecutive days from the first day of enrolment. A Licensed TCM acupuncturist administered the acupuncture. Acupuncture was administered bilaterally to LI4, SP6, UB31 and 32. Electro-acupuncture was administered to the sacrum UB31 and 32 points with current at 2Hz during the 30-minute treatment. needles retained for 30 minutes.

The control group received routine care (not specified).


OutcomesCaesarean section, cervical change, time from administration of acupuncture to delivery, mode of delivery spontaneous onset of labour, neonatal complications.


NotesPre trial power analysis undertaken.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskThe trial generated a computer-generated randomisation schedule.

Allocation concealment (selection bias)Low riskRandomisation was concealed in sealed envelopes.

Blinding of participants and personnel (performance bias)
All outcomes
High riskIt was not feasible for women and therapist to be blind to group allocation.

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskIt was unclear if the outcome assessor and analyst were blind to group allocation.

Incomplete outcome data (attrition bias)
All outcomes
Low riskNo losses to follow-up.

Selective reporting (reporting bias)Unclear riskNo study protocol available.

Other biasLow riskNo imbalance at randomisation.

Long 1994

MethodsThis trial compared pregnant women receiving auricular acupressure and rivanol with a control group who received rivanol only.


Participants400 women were recruited from China. No other details provided.


InterventionsAuricular acupuncture was applied to points: Inner genitals, Sympathetic, Shenmen, Liver, Yuanzhong and Adrenal gland, using a white mustard seed or a pill with adhesive plaster. The points were pressed by the woman until the points felt warm, distention and a numb sensation was generated. The control group received 1% rivanol.


OutcomesTime to induce labour, amount of bleeding, length of labour, and mental state of woman.


NotesContact was attempted with the author, advised the author had retired, and no contact could be established.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskWomen were equally divided into the 2 groups, no further details provide.

Allocation concealment (selection bias)Unclear riskNot stated.

Blinding of participants and personnel (performance bias)
All outcomes
High riskWomen would not be blind to their group allocation.

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskNot stated.

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskNot stated.

Selective reporting (reporting bias)Unclear riskNot stated.

Other biasUnclear riskNot stated.

Mackenzie 2011

MethodsThis was a double-blind manual, electro- and sham acupuncture study comparing acupuncture with a control group for analgesia for labour induction.


ParticipantsNulliparous women from the United Kingdon with a singleton pregnancy and fetal cephalic presentation with intact membranes undergoing labour induction using vaginal prostaglandins and low amniotomy were eligible for the study. Women with a previous experience of acupuncture were excluded.


Interventions105 women were randomised to receive manual acupuncture, electro-acupuncture or sham acupuncture or sham electro-acupuncture or no treatment. In the manual acupuncture and electro-acupuncture group the following points were needled: LI4, SP6, UB60, UB67. Serin needles (0.20 x 30-0.30 x 50 mm) were inserted to a depth of 15-20 mm with de qi sensation attained. In the manual group needles were stimulated intermittently and irregularly by hand for 30 minutes. In the electro-acupuncture group, points were stimulated by an electrical stimulator with 2-Hz pulses of 0.5 millisecond duration for 30 minutes, sufficient to cause non-painful muscle contractions. In the sham acupuncture group, needles were inserted at sites adjacent to the specific acupuncture points to a depth of 1-1.5 mm only and insufficient to provoke an unusual sensation. The sham electro-acupuncture group were connected to a electrical stimulator but the current was not activated.

Intrapartum care was provided by the routine delivery suite staff. Subsequent pain management including aromatherapy, TENS and parenteral opioids, and regional blockade was provided when requested or recommended by the attending midwife or obstetrician.


OutcomesThe primary outcome was the rate of intrapartum epidural analgesia requirement. Other outcomes included caesarean section, instrumental deliver, length of labour, Apgar scores.


NotesA power calculation was done based on the reduction in epidural rates.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskRandom numbers were generated using a computer program (RALLOC, Stata Corporation, Singleton, TX, USA) and randomisation was stratified by the acupuncturist.

Allocation concealment (selection bias)Low riskAllocations were concealed in numbered sealed opaque envelopes opened only after consent and immediately before treatment.

Blinding of participants and personnel (performance bias)
All outcomes
High riskStudy allocation was concealed from all except the acupuncturist, who was not involved with intrapartum management (double blind).

Women randomised to the ‘no-treatment’ control group were aware of their treatment group (single blind).

Great care was taken to conceal treatment allocation from those providing intrapartum care

Blinding of outcome assessment (detection bias)
All outcomes
Low riskAttempts to ensure outcome assessment was blind to group allocation.

The randomisation code was only revealed after completion of the clinical study.

                                                         

Incomplete outcome data (attrition bias)
All outcomes
Low riskAll participant data were included in the analysis. 2 protocol violations, 1 woman randomised to control group received acupuncture, and a second woman was randomised to electro-acupuncture but withdrew from the study before the acupuncture was administered.

Selective reporting (reporting bias)Low riskAll outcomes reported as per outcomes stated on trial registry.

Other biasLow riskNo imbalance at randomisation.

Martinez 2004

MethodsAcupuncture versus no treatment to examine the effect on uterine contractions.


ParticipantsThe Obstetrics Out-patient Department of the university hospital in the Phillipines.

50 pregnant women who were term, singleton, not in labour, and with uncomplicated course of pregnancy were included in the study. Exclusion criteria: women who were in the active phase of labour, who had previous caesarean section, premature rupture of membranes, concomitant medical illness, or allergy to metals, such as chromium or zinc.


InterventionsSpleen 6 (point Sanyinjiao) is on the lower leg approximately 3 inches proximal to the centre of the medial malleolus was stimulated bilaterally. SP6 was pierced on both sides of the lower extremities.  Two minutes were allotted for each patient for the insertion of the acupuncture needle. The control group received no intervention.


OutcomesThe frequency, intensity, duration, and interval of uterine contractions were measured for 20 minutes. No outcomes relevant to the review were reported.


NotesThe trial did not report on any outcomes relevant to this review.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskNot reported.

Allocation concealment (selection bias)Unclear riskNot reported.

Blinding of participants and personnel (performance bias)
All outcomes
High riskPartcipant and clinician not blinded.

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskNot reported.

Incomplete outcome data (attrition bias)
All outcomes
Low riskComplete data, no losses.

Selective reporting (reporting bias)Low riskSingle outcome collected relating to uterine contractions.

Other biasUnclear riskNo imbalance at randomisation.

Modlock 2010

MethodsAcupuncture versus sham non invasive acupuncture.


ParticipantsThe study was undertaken in Aarhus University Hospital, and Herning Hospital, Denmark, 1/2/2007-31/5/2008.

125 healthy pregnant women at gestational week 41+6 were recruited to the study.

 

Exclusion criteria: woman did not speak or understand the Danish language; multiple pregnancy; PROM or contractions at 4- to 5-minute intervals and increasing in intensity; previous caesarean section; diseases of the mother or unborn child (diabetes, pre-eclampsia, diseases of the heart, liver or kidneys, HIV/AIDS, malformation of the pelvis, psychological disorders, intrauterine growth restriction, hydrocephalus, suspected macrosomia, fetal malposition, antepartum stillbirth, treatment with anticoagulants, skin infections, allergy to metal, or major complications at previous delivery such as low Apgar score.


InterventionsAcupuncture was administered to points BL67, LI4, SP6, GV20.

The control used the park sham needle (non invasive) at real acupuncture points BL67, LI4, SP6, GV20.

The Park supporting device was used to hold the needle in place for both groups.

The intervention was delivered by trained midwives. The intervention was administered over 30 minutes, needles were stimulated every 10 minutes. Treatment commenced at 8.00am, and if the primary endpoint had not occurred by this time the treatment was repeated at 2.30pm


OutcomesThe primary outcome was achieved if the participant had undergone delivery or was in active labour, defined as rupture of fetal membranes and/or contractions at 4- to 5-minute (or more frequent) intervals and increasing in intensity within 24 hours.

 

Secondary outcomes were: the cervical dilatation was sufficient for amniotomy, cervical length and dilatation, length of labour, time from randomisation to start of active labour, postpartum bleeding, use of epidural, augmentation of contractions and instrumental delivery, as well as neonatal outcomes such as Apgar score and umbilical pH value when available.


NotesPower analysis undertaken.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskCentral computer-generated.

Allocation concealment (selection bias)Low riskPhone service.

Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskAcupuncturist not blind.

Blinding failed in 6 cases, 2 informed by partners (evenly distributed by group). 4 randomisations and administration of treatment was undertaken by the same midwife. Most women did not know which group they were in.

Blinding of outcome assessment (detection bias)
All outcomes
Low riskPrincipal investigator and nurses gathering data were blind to group allocation.

Incomplete outcome data (attrition bias)
All outcomes
Low risk1 lost to follow-up in the acupuncture group, and 2 lost to follow-up in the control group. 12 protocol violations in the acupuncture group, and 7 in the control group.

Selective reporting (reporting bias)Low riskAll outcomes reported as per entry on trial registry.

Other biasLow riskNo imbalance at randomisation.

Rabl 2001

Methods Women were randomised to acupuncture or no acupuncture.


Participants56 women were randomised to the trial in Austria. Inclusion criteria were EDC confirmed by ultrasound, uncomplicated pregnancy, singleton pregnancy with cephalic presentation. Exclusion criteria were cervical dilatation greater than 3 cm, premature rupture of membranes, previous caesarean section, maternal complications, e.g. pre-eclampsia, fetal growth retardation. Women were randomised at term.


InterventionsAll women were examined at term and at 2-day intervals thereafter. Fetal heart rate was monitored, the cervical length was measured by ultrasound, cervical mucus was obtained for fetal fibronectin test and the cervical status was assessed for the Bishops score. Women received acupuncture at term and at 2-day intervals thereafter.

Acupuncture points - LI4, and SP6 were bilaterally inserted. De qi needling sensation was achieved. Needles were left in for 20 minutes. If the woman was undelivered 10 days after her EDC labour was induced.

The control group received routine care.


OutcomesThe change in cervical length over time, time from the first fibronectin test to delivery, time period from EDC to time of delivery, number of postdate indications, length of first and second stage of labour, need for oxytocin augmentation and mode of delivery.


NotesNo sample-size calculation. Eleven (20%) women were excluded and follow-up data were not available on these women. Intention-to-treat analysis was reported.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskThe trial used a central randomisation service, with computer-generated sequence of random numbers.

Allocation concealment (selection bias)Low riskComputer generation.

Blinding of participants and personnel (performance bias)
All outcomes
High riskThe study participants were not blind to their group allocation. The care providers were blind to the woman’s study group.

Blinding of outcome assessment (detection bias)
All outcomes
High riskThe outcome assessors and statistician were not blind to group allocation.

Incomplete outcome data (attrition bias)
All outcomes
High riskThere were 11 (20%) post-randomisation exclusions and losses to follow-up.

Selective reporting (reporting bias)Unclear riskNo study protocol available.

Other biasUnclear riskLimited reporting, and unable to assess.

Romer 2000

MethodsRandomised controlled trial of acupuncture,and control using non specific acupuncture to examine the effect on cervical maturation and duration of labour. A non-randomised usual care group was recruited to the study.


Participants553 women were randomised to the trial at a Uni-centre hospital in Mannheim, Germany. Women were primiparous, with exclusion criteria stated as multiple pregnancy, placenta previa, planned caesarean section, any bleeding after 28 weeks, and any coagulation disorder.


InterventionsAcupuncture was administered weekly from 36 weeks until delivery. For the treatment group, fixed acu-points were administered including: ST36, SP6, GB34, BL67.Control acupuncture used non specific acupuncture including GC20, PC6, HT7. Points were needled using tonifying techniques, with a treatment duration of 20 minutes.


OutcomesBishop score, length of cervix, duration of labour.


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskBlock randomisation using random table numbers.

Allocation concealment (selection bias)Unclear riskNo other details available.

Blinding of participants and personnel (performance bias)
All outcomes
Low riskParticipants allocated to acupuncture or the non specific acupuncture group were blind to their group allocation.

Blinding of outcome assessment (detection bias)
All outcomes
Low riskOutcome assessor blind to group allocation.

Incomplete outcome data (attrition bias)
All outcomes
Low riskThere were no drop outs.

Selective reporting (reporting bias)Unclear riskNo details available.

Other biasUnclear riskNo details available.

Selmer-Olsen 2007

MethodsThis was a randomised controlled trial to assess the effect of acupuncture on the onset of labour and the need for induction after prelabour rupture of membranes. Women were randomised to receive acupuncture or standard care.


ParticipantsThe study took place in a hospital in Norway between 2004 and 2006. 106 women were included who were nulliparous with an uneventful singleton cephalic pregnancy between 37 and 42 weeks, with confirmed rupture of membranes without contractions of the uterus.


InterventionsAll women in the acupuncture group were needled at CV4. There were than diagnosed into 3 TCM categories based on their constitution. For Spleen qi deficiency, points were UB20, SP6 and ST36. For Liver qi stagnation, points were UB18, LR3, and LI4. For Kidney qi deficiency, points were UB23 and KI3. The following additional points could be used when appropriate, GVl 4, GV20, HT7, UB15, LU7, UB32, PC6, TH6. De qi was attained on all points. All Bladder channel points were needled bilaterally, the rest unilaterally. Single use needles (length: 2.5 and 4 cm) were retained for 30 minutes. Women were offered an additional treatment the following day if they were not in labour.

The control group received standard care. Standard care for nulliparas was expectant management at home for approximately 48 hours if cardiotocogram, temperature and amniotic fluid are normal, checked on a daily basis. To avoid infection, no digital examination was performed before onset of labour or induction.


OutcomesTime from PROM to active phase of labour. The active phase of labour was defined as a cervix dilatation of 3 cm and at least 2 uterine contractions in 10 minutes. The incidence of induction and additional outcomes of birth (Apgar score, epidural, oxytocin, caesarian sections, instrumental delivery) were reported. Self-reported physical well-being was registered using a 100-mm Visual Analogue Scale at randomisation and when they reached the active phase.


NotesIt is unclear who conducted the differential diagnosis to determine treatment and what instrument was used to guide the diagnosis and maximise inter-rater reliability.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskInternet based block randomisation.

Allocation concealment (selection bias)Low riskConcealed centrally.

Blinding of participants and personnel (performance bias)
All outcomes
High riskParticipants and clinicians were not blinded.

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskIt was not stated if assessors were blinded.

Incomplete outcome data (attrition bias)
All outcomes
High risk5 participants were lost to follow-up, and 1 participant refused further participation. 4 participants were excluded after randomisation, 1 had meconium-stained waters, 1 did not return questionnaire, 2 had intact membranes. These participants were not included in the analysis.

Selective reporting (reporting bias)High riskThe outcomes of Apgar score, epidural, instrumental delivery, caesarean sections, inductions, dilatation, oxytocin were reported but no between group analysis was conducted.

Other biasUnclear riskBaseline characteristics were not reported.

Smith 2008

Methods Randomised controlled trial of acupuncture versus sham acupuncture sessions to estimate the effectiveness of acupuncture to induce labour.


ParticipantsThe 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, or if there were contraindications to labour or vaginal birth, or if they presented with spontaneous prelabour rupture of membranes.


InterventionsThe acupuncture group received acupuncture at LI4, SP6, UB31, UB32, ST36 and LR3. Any underlying pathology from a TCM framework was examined and treated with addition points, e.g. KI7, UB20, UB21, LR3. Needles were retained for 30-40 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.


OutcomesThe primary outcome was the need for induction, a reduction in the need for prostaglandins, oxytocin, and artificial rupture of membranes, change in Bishop 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, non-reassuring fetal heart rate tracing, neonatal jaundice requiring phototherapy, neonatal seizures, acceptability of treatment by the mother, Bishop score, labour agentry scale of control in childbirth, likes and dislikes regarding participation in the trial.


NotesIntention-to-treat analysis was conducted. Sample size calculation reported.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskA 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 riskA central telephone randomisation service was available 7 days a week at the recruiting hospital.

Blinding of participants and personnel (performance bias)
All outcomes
Low riskParticipants 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 riskData 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 riskAll patients 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 riskAll outcomes reported as per trial registration.

Other biasLow risk Women in the sham group were older and there were also differences in the categorisation of the Bishop score.  The authors adjusted the primary outcomes for maternal age and the raw Bishop score.

Tremeau 1992

MethodsRandomised controlled trial examining the effect of acupuncture on cervical maturation. Parallel design of acupuncture versus usual care and sham acupuncture.


Participants128 women met the entry criteria and were randomised. Participants were recruited from a maternity hospital in France. Women were 37-38 weeks pregnant with a Bishops score of less than 4. Exclusion criteria included; at risk of premature delivery, planned caesarean section, placenta previa, receiving concurrent treatments such as yoga, homeopathy, acupuncture.


InterventionsAcupuncture points were selected based on those used to increase cervical maturation including: CV2, CV3, CV4, Liv3, BL60, GB34, ST36, LI4, SP6, BL67. The acupuncture control was pricked with needles at sites 1 cm from the bilateral acu-point, and 1 cm from the med line points, and a third group received usual care.

Three treatment sessions were administered, with electro-stimulation for 20 minutes.


OutcomesThe Bishops score was assessed 48 hours after the last acupuncture session, duration of labour, time to 2 cm cervical dilatation.


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskTable of random numbers.

Allocation concealment (selection bias)Unclear riskNot reported.

Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskNo details were reported on whether the integrity of blinding between acupuncture and the sham group was maintained.

Blinding of outcome assessment (detection bias)
All outcomes
Low riskThe outcome assessment was undertaken by a clinician blind to group.

Incomplete outcome data (attrition bias)
All outcomes
Unclear risk16% of women did not complete the protocol due to spontaneous labour before the second examination, 2 women declined the second examination and 1 woman did not return for acupuncture.

Selective reporting (reporting bias)Unclear riskLimited reporting unable to assess.

Other biasUnclear riskNo imbalance in baseline characteristics.

 
Characteristics of excluded studies [ordered by study ID]

StudyReason for exclusion

Aghamohammadi 2011This was a randomised double-blind study comparing TENS versus sham TENS on LI4 and SP6 in 64 nulliparous women who were in first stage of active labour. Labour time was found to be significantly shorter in the TENS group as was the need for oxytocin to augment labour. The trial was excluded as it did not meet the inclusion criteria of an acupuncture intervention - no needles were used and it did not have a primary outcome that met our inclusion criteria.

Bo 2006This study evaluated the role of acupuncture primarily during labour on pain relief. No data on induction outcomes were reported.

Dorr 1990The evidence regarding the clinical effectiveness of this technique is limited. This controlled clinical trial undertaken in Czechoslovakia consisted of women between 39 to 43 weeks with a cervical score greater than 5 (with no regular uterine contractions). Sixteen women received acupuncture. In 1 group electrical acupuncture commenced after the discharge of amniotic fluid (up to 4 hours); in the other group, stimulation began 6 or more hours after the discharge of amniotic fluid. Spontaneous vaginal delivery was achieved in 13 women.

Dunn 1989This comparison between electrical acupuncture stimulation or placebo acupuncture assessed the onset of uterine contractions in 20 postdate pregnant women. There was evidence of strong contractions in the treatment group. TENS does not meet the eligibility criteria for the review.

Kubista 1974This study reported on 60 pregnant women who received acupuncture (ST36, KI8, GB34 and UB 62) compared to a control of 60 pregnant women from the same clinic with a primary outcome of length of labour. The study was not randomised.

Li 1996This study was a quasi-randomised trial and was excluded.

Lyngso 2010This trial included women who were already in labour and was therefore excluded.

So 1979A controlled clinical trial was undertaken at a hospital in Hong Kong. 60 women were allocated to 3 groups: electro-acupuncture (stimulation of SP6 and LI4); acupuncture at these same points on 1 side of the body only; and thirdly, sham acupuncture. No data were available on the results of the trial.

 
Characteristics of studies awaiting assessment [ordered by study ID]
Liu 2012

MethodsSingle blind randomised controlled trial of electro-acupuncture on labour.

Participants38 women.

InterventionsWomen randomised to electro-acupuncture, 37 to sham acupuncture and 36 to a control.

OutcomesBlood pressure, heart rate, postpartum bleeding, Apgar score, length of labour.

NotesChinese manuscript, awaiting translation.

 
Characteristics of ongoing studies [ordered by study ID]
Fabio 2007

Trial name or titleEfficacy of acupuncture on induction of labour.

MethodsRandomised controlled trial.

ParticipantsWomen at 40 + 2 - 40 + 4 gestational age.

InterventionsAcupuncture versus placebo. Acupuncture administered daily from 40 + 4 for 7 days.

OutcomesTo evaluate the efficacy of acupuncture administered daily from 40 weeks + 4 days of gestation for induction of labour respect with placebo, to evaluate safety of acupuncture.

Starting dateNovember 2007. Completed January 2009.

Contact informationFacchinetti Fabio, University of Modena and Reggio Emilia, Italy.

NotesThe purpose of this study is to evaluate the efficacy and safety of acupuncture for the induction of labour in pregnant women at the 40 weeks + 4 days of gestation.

 
Comparison 1. Acupuncture versus control

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Caesarean section9Risk Ratio (M-H, Random, 95% CI)Subtotals only

    1.1 Acupuncture versus sham control
6654Risk Ratio (M-H, Random, 95% CI)0.95 [0.69, 1.30]

    1.2 Acupuncture versus usual care
6361Risk Ratio (M-H, Random, 95% CI)0.69 [0.40, 1.20]

 2 Neontal seizure1Risk Ratio (M-H, Fixed, 95% CI)Subtotals only

    2.1 Acupuncture versus sham
1364Risk Ratio (M-H, Fixed, 95% CI)1.01 [0.06, 16.04]

 3 Cervical maturity within 24 hours (Bishop score)2Mean Difference (IV, Fixed, 95% CI)Subtotals only

    3.1 Acupuncture versus sham acupuncture
1125Mean Difference (IV, Fixed, 95% CI)0.40 [0.11, 0.69]

    3.2 Acupuncture versus usual care
167Mean Difference (IV, Fixed, 95% CI)1.30 [0.11, 2.49]

 4 Oxytocin augmentation7Risk Ratio (M-H, Fixed, 95% CI)Subtotals only

    4.1 Acupuncture versus sham
4833Risk Ratio (M-H, Fixed, 95% CI)0.97 [0.78, 1.21]

    4.2 Acupuncture versus usual care
3257Risk Ratio (M-H, Fixed, 95% CI)1.08 [0.86, 1.34]

 5 Need for epidural8Risk Ratio (M-H, Fixed, 95% CI)Subtotals only

    5.1 Acupuncture versus sham acupuncture
5571Risk Ratio (M-H, Fixed, 95% CI)1.02 [0.88, 1.19]

    5.2 Acupuncture versus usual care
5351Risk Ratio (M-H, Fixed, 95% CI)0.92 [0.77, 1.11]

 6 Instrumental vaginal delivery8Risk Ratio (M-H, Random, 95% CI)Subtotals only

    6.1 Acupuncture versus sham
5610Risk Ratio (M-H, Random, 95% CI)1.19 [0.85, 1.65]

    6.2 Acupuncture versus usual care
5351Risk Ratio (M-H, Random, 95% CI)0.91 [0.50, 1.64]

 7 Meconium-stained liquor1Risk Ratio (M-H, Fixed, 95% CI)Subtotals only

    7.1 Acupuncture versus sham
1364Risk Ratio (M-H, Fixed, 95% CI)0.81 [0.56, 1.16]

 8 Apgar score less than 76Risk Ratio (M-H, Fixed, 95% CI)Subtotals only

    8.1 Acupuncture versus sham
4559Risk Ratio (M-H, Fixed, 95% CI)0.67 [0.20, 2.21]

    8.2 Acupuncture versus usual care
3242Risk Ratio (M-H, Fixed, 95% CI)0.35 [0.01, 8.48]

 9 Neonatal care admission3Risk Ratio (M-H, Random, 95% CI)Subtotals only

    9.1 Acupuncture versus sham
3141Risk Ratio (M-H, Random, 95% CI)0.82 [0.02, 37.11]

    9.2 Acupuncture versus usual care
145Risk Ratio (M-H, Random, 95% CI)0.65 [0.03, 14.97]

 10 Perinatal death1364Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

    10.1 Acupuncture versus sham
1364Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

 11 Perineal tear191Risk Ratio (M-H, Fixed, 95% CI)1.22 [0.95, 1.56]

    11.1 Acupuncture versus usual care
191Risk Ratio (M-H, Fixed, 95% CI)1.22 [0.95, 1.56]

 12 Maternal infection2Risk Ratio (M-H, Fixed, 95% CI)Subtotals only

    12.1 Acupuncture versus usual care
2136Risk Ratio (M-H, Fixed, 95% CI)1.64 [0.43, 6.32]

    12.2 Acupuncture versus sham
144Risk Ratio (M-H, Fixed, 95% CI)1.29 [0.43, 3.88]

 13 Fetal infection191Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

    13.1 Acupuncture versus usual care
191Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

 14 Postpartum bleeding > 500 mL3Risk Ratio (M-H, Fixed, 95% CI)Subtotals only

    14.1 Acupuncture versus sham
3542Risk Ratio (M-H, Fixed, 95% CI)1.02 [0.67, 1.54]

    14.2 Acupuncture versus usual care
152Risk Ratio (M-H, Fixed, 95% CI)0.5 [0.10, 2.50]

 15 Maternal death1364Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

    15.1 Acupuncture versus sham
1364Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

 16 Time from trial entry to birth of baby (days; hours)3Std. Mean Difference (IV, Random, 95% CI)Subtotals only

    16.1 Acupuncture versus sham acupuncture
261Std. Mean Difference (IV, Random, 95% CI)-0.22 [-0.99, 0.55]

    16.2 Acupuncture versus usual care
2100Std. Mean Difference (IV, Random, 95% CI)0.25 [-0.77, 1.27]

 17 Maternal satisfaction167Risk Ratio (M-H, Fixed, 95% CI)1.29 [0.99, 1.67]

    17.1 Acupuncture versus usual care
167Risk Ratio (M-H, Fixed, 95% CI)1.29 [0.99, 1.67]

 18 Need for induction methods7Risk Ratio (M-H, Random, 95% CI)Subtotals only

    18.1 Acupuncture versus sham
4977Risk Ratio (M-H, Random, 95% CI)1.03 [0.91, 1.16]

    18.2 Acupuncture versus usual care
4259Risk Ratio (M-H, Random, 95% CI)1.00 [0.69, 1.45]

 19 Length of labour4Std. Mean Difference (IV, Random, 95% CI)Subtotals only

    19.1 Acupuncture versus sham
3694Std. Mean Difference (IV, Random, 95% CI)-0.18 [-0.58, 0.23]

    19.2 Acupuncture versus usual care
167Std. Mean Difference (IV, Random, 95% CI)0.67 [0.18, 1.17]