Cochrane Database Syst Rev. 2017 Oct; 2017(10): CD002962. Monitoring Editor: Caroline A Smith, Western Sydney University, National Institute of Complementary Medicine (NICM), Locked Bag 1797, SydneyNew South WalesAustralia, 2751 Western Sydney University, School of Nursing and Midwifery, Locked Bag 1797, PenrithNSWAustralia, 2751 AbstractBackgroundThis is one of a series of reviews of methods of cervical ripening and labour induction. The use of complementary therapies is increasing. Women may look to complementary therapies during pregnancy and childbirth to be used alongside conventional medical practice. Acupuncture involves the insertion of very fine needles into specific points of the body. Acupressure is using the thumbs or fingers to apply pressure to specific points. The limited observational studies to date suggest acupuncture for induction of labour has no known adverse effects to the fetus, and may be effective. However, the evidence regarding the clinical effectiveness of this technique is limited. ObjectivesTo determine, from the best available evidence, the effectiveness and safety of acupuncture and acupressure for third trimester cervical ripening or induction of labour. Search methodsWe searched the Cochrane Pregnancy and Childbirth Group's Trials Register (30 November 2016), PubMed (1966 to 25 November 2016), ProQuest Dissertations & Theses (25 November 2016), CINAHL (25 November 2016), Embase (25 November 2016), the WHO International Clinical Trials Registry Portal (ICTRP) (3 October 2016), and bibliographies of relevant papers. Selection criteriaRandomised controlled trials comparing acupuncture or acupressure, used for third trimester cervical ripening or labour induction, with placebo/no treatment or other methods on a predefined list of labour induction methods. Data collection and analysisTwo review authors independently assessed trials for inclusion and risk of bias, extracted data, and checked them for accuracy. The quality of the evidence was assessed using GRADE. Main resultsThis updated review includes 22 trials, reporting on 3456 women. The trials using manual or electro‐acupuncture were compared with usual care (eight trials, 760 women), sweeping of membranes (one trial, 207 women), or sham controls (seven trials, 729 women). Trials using acupressure were compared with usual care (two trials, 151 women) or sham controls (two trials, 239 women). Many studies had a moderate risk of bias. Overall, few trials reported on primary outcomes. No trial reported vaginal delivery not achieved within 24 hours and uterine hyperstimulation with fetal heart rate (FHR) changes. Serious maternal and neonatal death or morbidity were only reported under acupuncture versus sham control. Acupuncture versus sham control There was no clear difference in caesarean sections between groups (average risk ratio (RR) 0.80, 95% confidence interval (CI) 0.56 to 1.15, eight trials, 789 women; high‐quality evidence). There were no reports of maternal death or perinatal death in the one trial that reported this outcome. There was evidence of a benefit from acupuncture in improving cervical readiness for labour (mean difference (MD) 0.40, 95% CI 0.11 to 0.69, one trial, 125 women), as measured by cervical maturity within 24 hours using Bishop's score. There was no evidence of a difference between groups for oxytocin augmentation, epidural analgesia, instrumental vaginal birth, meconium‐stained liquor, Apgar score < 7 at five minutes, neonatal intensive care admission, maternal infection, postpartum bleeding greater than 500 mL, time from the trial to time of birth, use of induction methods, length of labour, and spontaneous vaginal birth. Acupuncture versus usual care There was no clear difference in caesarean sections between groups (average RR 0.77, 95% CI 0.51 to 1.17, eight trials, 760 women; low‐quality evidence). There was an increase in cervical maturation for the acupuncture (electro) group compared with control (MD 1.30, 95% CI 0.11 to 2.49, one trial, 67 women) and a shorter length of labour (minutes) in the usual care group compared to electro‐acupuncture (MD 124.00, 95% CI 37.39 to 210.61, one trial, 67 women). There appeared be a differential effect according to type of acupuncture based on subgroup analysis. Electro‐acupuncture appeared to have more of an effect than manual acupuncture for the outcomes caesarean section (CS), and instrumental vaginal and spontaneous vaginal birth. It decreased the rate of CS (average RR 0.54, 95% CI 0.37 to 0.80, 3 trials, 327 women), increased the rate of instrumental vaginal birth (average RR 2.30, 95%CI 1.15 to 4.60, two trials, 271 women), and increased the rate of spontaneous vaginal birth (average RR 2.06, 95% CI 1.20 to 3.56, one trial, 72 women). However, subgroup analyses are observational in nature and so results should be interpreted with caution. There were no clear differences between groups for other outcomes: oxytocin augmentation, use of epidural analgesia, Apgar score < 7 at 5 minutes, neonatal intensive care admission, maternal infection, perineal tear, fetal infection, maternal satisfaction, use of other induction methods, and postpartum bleeding greater than 500 mL. Acupuncture versus sweeping if fetal membranes One trial of acupuncture versus sweeping of fetal membranes showed no clear differences between groups in caesarean sections (RR 0.64, 95% CI 0.34 to 1.22, one trial, 207 women, moderate‐quality evidence), need for augmentation, epidural analgesia, instrumental vaginal birth, Apgar score < 7 at 5 minutes, neonatal intensive care admission, and postpartum bleeding greater than 500 mL. Acupressure versus sham control There was no evidence of benefit from acupressure in reducing caesarean sections compared to control (RR, 0.94, 95% CI 0.68 to 1.30, two trials, 239 women, moderate‐quality evidence). There was no evidence of a clear benefit in reduced oxytocin augmentation, instrumental vaginal birth, meconium‐stained liquor, time from trial intervention to birth of the baby, and spontaneous vaginal birth. Acupressure versus usual care There was no evidence of benefit from acupressure in reducing caesarean sections compared to usual care (RR 1.02, 95% CI 0.68 to 1.53, two trials, 151 women, moderate‐quality evidence). There was no evidence of a clear benefit in reduced epidural analgesia, Apgar score < 7 at 5 minutes, admission to neonatal intensive care, time from trial intervention to birth of the baby, use of other induction methods, and spontaneous vaginal birth. Authors' conclusionsOverall, there was no clear benefit from acupuncture or acupressure in reducing caesarean section rate. The quality of the evidence varied between low to high. Few trials reported on neonatal morbidity or maternal mortality outcomes. Acupuncture showed some benefit in improving cervical maturity, however, more well‐designed trials are needed. Future trials could include clinically relevant safety outcomes. Plain language summaryAcupuncture or acupressure for induction of labour What is the issue? Induction of labour is offered to pregnant women when it is thought the outcome will be better for the mother or her baby if the pregnancy does not continue and the baby is born. Common reasons for induction include the pregnancy going beyond the due date, pre‐term or pre‐labour rupture of the membranes, and concerns about the health of the mother or baby such as pre‐eclampsia or poor growth of the baby. Some women look to using complementary therapies alongside conventional medical practice for induction. Acupuncture involves the insertion of fine needles into specific points of the body while acupressure involves using the thumbs or fingers to apply pressure to specific points. Both have been used to help soften and dilate the cervix with onset of labour contractions. They may provide a way of reducing labour pain and avoiding a medical induction with other methods such as prostaglandins. Why is this important? Medical inductions can have significant side effects. Many women therefore choose complementary and alternative methods to bring on labour. Acupuncture is practiced by many midwives together with usual care, and early studies have suggested a benefit from acupuncture. What evidence did we find? In October 2016, we searched for evidence from randomised controlled trials on the effectiveness and safety of acupuncture. We identified eight additional trials that were eligible for the review since the last version of the review in 2013. In total, we found 22 trials which reported on 3456 pregnant women. The authors rated most of the trials as having moderate risk of bias. Moderate to high‐quality evidence found that acupuncture and acupressure did not reduce caesarean sections. Acupuncture may promote a more favourable state of the cervix within 24 hours in the two trials (192 women) that looked at this. Only one trial reported on serious outcomes for the mother or her baby, finding no serious incidents in either the acupuncture or the control group (low‐quality evidence). What does this mean? Acupuncture and acupressure do not appear to reduce the need for caesarean section but may increase the readiness of the cervix for labour. Acupressure did not help in any of the outcomes we examined in this review. The trials varied in the delivery of acupuncture and acupressure, the comparison groups, and the outcomes looked at. These variations mean that we have to be careful in how we interpret the findings. More studies are needed to determine if acupuncture or acupressure increases the number of women who experience vaginal deliveries within 24 hours and to examine the safety of acupuncture and acupressure. Summary of findingsBackgroundDescription of the conditionSometimes it is necessary to bring on labour artificially because of safety concerns for the mother or baby. This review is one of a series of reviews of methods of labour induction using a standardised protocol. For more detailed information on the rationale for this methodological approach, please refer to the currently published 'generic' protocol (Hofmeyr 2009). The generic protocol describes how a number of standardised reviews will be combined to compare various methods of preparing the cervix of the uterus and inducing labour. Description of the interventionThe use of complementary and alternative medicine (CM) has become popular with consumers worldwide. A recent review of 14 studies with large sample sizes (n > 200) on the use of CM in pregnancy identified a prevalence rate ranging from 1% to 87% (with nine falling between 20% and 60%) (Adams 2009). The review identified use of various complementary therapies including acupuncture and acupressure, aromatherapy, massage, yoga, homeopathy, and chiropractic care. The review also showed that many pregnant women had used more than one complementary product or service (Adams 2009). Some women look to alternative therapies during pregnancy and childbirth to be used alongside conventional medical practice. There is evidence of midwives having positive views towards CM, and seeing a role of CM for supporting women in labour and birth as positive (Levett 2016a). In the United Kingdom, a recent survey found a wide variety of CM therapies are recommended to pregnant women by approximately a third of healthcare professionals (Stewart 2014). For some women with a prolonged pregnancy, an induction of labour may be perceived to intervene in the natural process of pregnancy, and may drastically change their expected plan of care during pregnancy. The reasons why pregnant women are interested in using complementary therapies to ripen the cervix and/or induce labour is an important question and needs to be answered when evaluating new options of care. Acupuncture has been used for more than two thousand years in China and Japan. The diagnosis and treatment prescribed by traditional Chinese medicine (TCM) is influenced by the systems of medicine and philosophy of ancient China. Acupuncture involves the insertion of fine needles into the skin and underlying tissues at precise points on the body. The needle can be left alone, stimulated by turning in various ways, or stimulated by electricity. Electro‐acupuncture involves the use of electricity to stimulate the acupuncture point. To do this, a needle is inserted and a terminal is attached to the handle, while the other terminal is connected to a second needle or neutral electrode. Acupressure uses the same points as acupuncture but applies manual pressure, usually with the finger or thumb, on these points rather than the insertion of a needle. Laser acupuncture is a non‐penetrative form of acupuncture, which uses low power laser light to stimulate acupuncture points. Over time, different styles of acupuncture have been practiced by acupuncturists. Acupuncture treatment is composed of needling aspects (choice of points and needling techniques), specific components relating to the style of diagnosis and treatment used, and generic needling components not specific to acupuncture such as belief, time, and attention given to the patient. In parts of Europe and Asia, acupuncture and acupressure have been described as methods to alleviate labour pains, and ripen the cervix. More recently, they have been used to stimulate the onset of labour. Three case series have documented the role of acupuncture for the induction of labour (Tsuei 1974; Tsuei 1977; Yip 1976). Induction of labour using electro‐acupuncture has been reported by Yip 1976. Labour was successfully induced in 21 of the 31 women, with pregnancy duration ranging from 38 to 42 weeks. The pattern of uterine activity was similar to that of normal labour. In a second study, acupuncture with and without electrical stimulation was used to induce labour in 12 pregnant women with a gestational age from 19 to 43 weeks (Tsuei 1974). The success rate was 83% and average induction to delivery time was 13.1 hours. In the third study, 34 term and post‐term women and seven women with intrauterine fetal deaths were induced using electro‐acupuncture. Labour was successfully induced in 32 (78%) women (Tsuei 1977). The limited observational studies to date have suggested that acupuncture for induction of labour appears safe, has no known adverse effects to the fetus, and may be effective. Two nonrandomised trials have examined whether acupuncture could initiate contractions in women at term (Kubista 1975: Theobald 1973). In the trial by Theobald (Theobald 1973), four electrodes were applied to the skin of the abdomen to induce labour in the treatment group. Treatment was given to 27 women and compared with 102 women who were controls. In the treatment group, 20 (77%) women gave birth on or up to four days before the estimated date of confinement, compared with 47 (46%) in the control group. In the second trial, electro‐acupuncture was administered to 35 women, and 35 women received no electro‐acupuncture. An increase in the intensity of labour contraction frequency was observed in 31 women in the treatment group. In the control group, no increase in labour activity was observed (Kubista 1975). How the intervention might workThe mechanism underlying acupuncture and acupressure to induce labour is speculative at this stage but may involve stimulation of the uterus by hormonal changes or by the nervous system. In animal studies, low frequency electrical stimulation of the neuro‐hypophyseal system (the posterior lobe of the pituitary gland) induces the secretion of oxytocin. Parasympathetic (the system in the body that is responsible for bodily functions at rest) stimulation close to term has been shown to have an influence on the uterus (Bell 1972). Stimulation of acupuncture points is known to increase the discharge of thalamic nuclei (an increase in firing of the neurons in the thalamus) and the hypothalamic anterior pituitary system (the area of the brain that links both the nervous and endocrine system) (Liao 1979). It is hypothesised that acupuncture neuronal (related to neurons) stimulation may increase uterine contractility either by central oxytocin release or by parasympathetic stimulation of the uterus (Tempfeer 1998). Why it is important to do this reviewInduction of labour traditionally involves mechanical means (membrane sweeping, intrauterine catheter, artificial rupture of membranes) or pharmacological means (prostaglandin or synthetic oxytocin). Some women may seek to avoid these methods of induction, finding them uncomfortable, unacceptable, or both. There are risks and benefits associated with all these procedures. While membrane sweeping may result in women going into labour, softening the cervix and reducing the need for induction (Boulvain 2005), it may also be painful and/or not successful, and uncomplicated vaginal bleeding may occur following the procedure (De Miranda 2006). While membrane sweeping is not pharmacological, it needs to be undertaken by a registered midwife or doctor. Other mechanical or pharmacological means of induction of labour may lead to increased intervention in birth and morbidity for women (Khireddine 2013). This review is one of a series of reviews of methods of labour induction using a standardised protocol. For more detailed information on the rationale for this methodological approach, please refer to the currently published protocol (Hofmeyr 2009). ObjectivesTo determine, from the best available evidence, the effectiveness and safety of acupuncture and acupressure for third trimester cervical ripening or induction of labour. MethodsCriteria for considering studies for this reviewTypes of studiesRandomised or quasi randomised controlled trials comparing manual, laser or electro‐acupuncture or acupressure for cervical ripening or labour induction, with placebo/no treatment, sham acupuncture/acupressure or other methods listed on a predefined list of methods of labour induction; the trials included some form of random allocation to either group. Abstracts and cross‐over trials were not included. Cluster‐randomised trials were included. The control group in a trial of acupuncture can involve sham (mock) acupuncture where the needles are inserted away from the usual location, with the depth and needle stimulation being the same. Or alternatively, minimal acupuncture which involves needles being inserted away from the usual location, with very shallow needling and very slight stimulation, or the use of the noninvasive placebo needle (Streitberger 1998). Types of participantsPregnant women carrying a viable fetus due for third trimester induction of labour. We planned to use subgroup analysis for any possible differences in the effect of interventions in these groups. Types of interventionsManual, laser, or electro‐acupuncture or acupressure compared with placebo, no treatment, sham acupuncture/acupressure, or any other method on a predefined list of methods of labour induction, as detailed below. To avoid duplication of data in a series of reviews on interventions for labour induction, the labour induction methods were listed in a specific order, from one to 27, as outlined below. The methods for these reviews are described in the generic protocol for cervical ripening and labour induction in late pregnancy (Hofmeyr 2009). Each review included comparisons between one of the methods (from two to 26) with only those methods above it on the list. Thus, this review of acupuncture (number 20 on the list) could include comparisons with any of the following: (1) placebo/no treatment; (2) vaginal prostaglandins; (3) intracervical prostaglandins; (4) intravenous oxytocin; (5) amniotomy; (6) intravenous oxytocin with amniotomy; (7) vaginal misoprostol; (8) oral misoprostol; (9) mechanical methods including extra‐amniotic Foley catheter; (10) membrane sweeping; (11) extra‐amniotic prostaglandins (12) intravenous prostaglandins; (13) oral prostaglandins; (14) mifepristone; (15) oestrogens with or without amniotomy; (16) corticosteroids; (17) relaxin; (18) hyaluronidase; (19) castor oil, bath, and/or enema. The current list is as follows: (1) placebo/no treatment; Types of outcome measuresPrimary outcomesClinically relevant outcomes for trials of methods of cervical ripening/labour induction were prespecified by two authors of labour induction reviews (Justus Hofmeyr and Zarko Alfirevic) (Hofmeyr 2009). Differences were settled by discussion. Five primary outcomes were chosen as being most representative of the clinically important measures of effectiveness and complications. It was agreed that subgroup analyses would be limited to the primary outcomes: Perinatal and maternal morbidity and mortality are composite outcomes. This is not an ideal solution because some components are clearly less severe than others. It is possible for one intervention to cause more deaths but less severe morbidity. However, in the context of labour induction at term, this is unlikely. All these events will be rare, and a modest change in their incidence will be easier to detect if composite outcomes are presented. The incidence of individual components were explored as secondary outcomes (see below). Secondary outcomesSecondary outcomes related to measures of effectiveness, complications and satisfaction. Measures of effectiveness: Complications: Measures of satisfaction: Acupuncture‐specific outcomes: While all the above outcomes were sought, only those with data appeared in the analysis tables. The terminology of uterine hyperstimulation is problematic (Curtis 1987). In the reviews, we used the term 'uterine hyperstimulation without FHR changes' to include uterine tachysystole (more than five contractions per 10 minutes for at least 20 minutes) and uterine hypersystole/hypertonus (a contraction lasting at least two minutes) and 'uterine hyperstimulation with FHR changes' to denote uterine hyperstimulation syndrome (tachysystole or hypersystole with FHR changes such as persistent decelerations, tachycardia, or decreased short‐term variability). Search methods for identification of studiesThe following methods section of this review is based on a standard template used by Cochrane Pregnancy and Childbirth. Electronic searchesWe searched Cochrane Pregnancy and Childbirth’s Trials Register by contacting their Information Specialist (30 November 2016). The Register is a database containing over 24,000 reports of controlled trials in the field of pregnancy and childbirth. For full search methods used to populate Pregnancy and Childbirth’s Trials Register including the detailed search strategies for CENTRAL, MEDLINE, Embase and CINAHL, the list of handsearched journals and conference proceedings, and the list of journals reviewed via the current awareness service, please follow this link to the editorial information about the Cochrane Pregnancy and Childbirth in the Cochrane Library and select the ‘Specialised Register’ section from the options on the left side of the screen. Briefly, Cochrane Pregnancy and Childbirth’s Trials Register is maintained by their Information Specialist and contains trials identified from:
Search results are screened by two people and the full text of all relevant trial reports identified through the searching activities described above is reviewed. Based on the intervention described, each trial report is assigned a number that corresponds to a specific Pregnancy and Childbirth review topic (or topics), and is then added to the Register. The Information Specialist searches the Register for each review using this topic number rather than keywords. This results in a more specific search set which has been fully accounted for in the relevant review sections (Included studies; Excluded studies; Ongoing studies). In addition, we searched PubMed (1966 to 25 November 2016), ProQuest Dissertations & Theses (25 November 2016), CINAHL (25 November 2016), Embase (25 November 2016), the WHO International Clinical Trials Registry Portal (ICTRP) (3 October 2016), and bibliographies of relevant papers. See Appendix 1 for search strategies used. Searching other resourcesWe searched the reference lists of retrieved studies. We did not apply any language or date restrictions. Data collection and analysisFor methods used in the previous version of this review, seeSmith 2013. For this update, the following methods were used for assessing the reports that were identified as a result of the updated search. The following methods section of this review is based on a standard template used by Cochrane Pregnancy and Childbirth. Selection of studiesTwo review authors independently assessed for inclusion all the potential studies identified as a result of the search strategy. We resolved any disagreement through discussion or, if required, we consulted the third review author. Data extraction and managementWe designed a form to extract data. For eligible studies, two review authors extracted the data using the agreed form. We resolved discrepancies through discussion or, if required, we consulted the third review author. Data were entered into Review Manager software (RevMan 2014) and checked for accuracy. When information regarding any of the above was unclear, we planned to contact authors of the original reports to provide further details. Assessment of risk of bias in included studiesTwo review authors independently assessed risk of bias for each study using the criteria outlined in the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011). Any disagreement was resolved by discussion or by involving a third assessor. (1) Random sequence generation (checking for possible selection bias)We described for each included study the method used to generate the allocation sequence in sufficient detail to allow an assessment of whether it should produce comparable groups. We assessed the method as:
(2) Allocation concealment (checking for possible selection bias)We described for each included study the method used to conceal allocation to interventions prior to assignment and assessed whether intervention allocation could have been foreseen in advance of, or during recruitment, or changed after assignment. We assessed the methods as:
(3.1) Blinding of participants and personnel (checking for possible performance bias)We described for each included study the methods used, if any, to blind study participants and personnel from knowledge of which intervention a participant received. We considered that studies were at low risk of bias if they were blinded, or if we judged that the lack of blinding unlikely to affect results. We assessed blinding separately for different outcomes or classes of outcomes. We assessed the methods as:
(3.2) Blinding of outcome assessment (checking for possible detection bias)We described for each included study the methods used, if any, to blind outcome assessors from knowledge of which intervention a participant received. We assessed blinding separately for different outcomes or classes of outcomes. We assessed methods used to blind outcome assessment as:
(4) Incomplete outcome data (checking for possible attrition bias due to the amount, nature and handling of incomplete outcome data)We described for each included study, and for each outcome or class of outcomes, the completeness of data including attrition and exclusions from the analysis. We stated whether attrition and exclusions were reported and the numbers included in the analysis at each stage (compared with the total randomised participants), reasons for attrition or exclusion where reported, and whether missing data were balanced across groups or were related to outcomes. Where sufficient information was reported, or could be supplied by the trial authors, we planned to reinclude missing data in the analyses which we undertook. We assessed methods as:
(5) Selective reporting (checking for reporting bias)We described for each included study how we investigated the possibility of selective outcome reporting bias and what we found. We assessed the methods as:
(6) Other bias (checking for bias due to problems not covered by (1) to (5) above)We described for each included study any important concerns we had about other possible sources of bias. (7) Overall risk of biasWe made explicit judgements about whether studies were at high risk of bias, according to the criteria given in the Handbook (Higgins 2011). With reference to (1) to (6) above, we planned to assess the likely magnitude and direction of the bias and whether we considered it was likely to impact on the findings. In future updates, we will explore the impact of the level of bias through undertaking sensitivity analyses ‐ seeSensitivity analysis. Assessment of the quality of the evidence using the GRADE approachFor this update, the quality of the evidence was assessed using the GRADE approach as outlined in the GRADE Handbook in order to assess the quality of the body of evidence relating to the following outcomes for the main comparisons: acupuncture compared to sham control; acupuncture compared to usual care; acupuncture compared to sweeping of fetal membranes; acupressure compared to sham control; and acupressure compare to usual care.
GRADEpro Guideline Development Tool was used to import data from Review Manager 5.3 (RevMan 2014) in order to create ’Summary of findings’ tables. A summary of the intervention effect and a measure of quality for each of the above outcomes was produced using the GRADE approach. The GRADE approach uses five considerations (study limitations, consistency of effect, imprecision, indirectness, and publication bias) to assess the quality of the body of evidence for each outcome. The evidence can be downgraded from 'high quality' by one level for serious (or by two levels for very serious) limitations, depending on assessments for risk of bias, indirectness of evidence, serious inconsistency, imprecision of effect estimates, or potential publication bias. Measures of treatment effectDichotomous dataFor dichotomous data, we presented results as summary risk ratios with 95% confidence intervals. Continuous dataWe used the mean difference if outcomes were measured in the same way between trials. We used the standardised mean difference to combine trials that measured the same outcome, but used different methods. Unit of analysis issuesCluster‐randomised trialsWe planned to include cluster‐randomised trials in the analyses along with individually‐randomised trials. No cluster trials were included in this update. In future updates, if identified and eligible for inclusion, we will adjust either their sample sizes or standard errors, as appropriate, using the methods described in the Cochrane Handbook for Systematic Reviews of Interventions (Section 16.3.4 or 16.3.6), using an estimate of the intracluster correlation coefficient (ICC) derived from the trial (if possible), from a similar trial, or from a study of a similar population. If we use ICCs from other sources, we will report this and conduct sensitivity analyses to investigate the effect of variation in the ICC. If we identify both cluster‐randomised trials and individually‐randomised trials, we plan to synthesise the relevant information. We will consider it reasonable to combine the results from both if there is little heterogeneity between the study designs and the interaction between the effect of intervention and the choice of randomisation unit is considered to be unlikely. We will also acknowledge heterogeneity in the randomisation unit and perform a subgroup analysis to investigate the effects of the randomisation unit. Cross‐over trialsThis study design was not eligible for inclusion due to the unclear washout period when using acupuncture. Other unit of analyses issuesTrials with multiple arms were included and are described in the Characteristics of included studies. For example, acupuncture might be compared with sham acupuncture and with another arm where no acupuncture was delivered. If there were two acupuncture groups, data from both treatment arms were combined into one group. For studies with a sham control and no treatment control group, the shared intervention was divided evenly between groups as described in the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011). Where outcomes were repeated measures, analysis of outcomes was undertaken at the end of the intervention. Dealing with missing dataFor included studies, levels of attrition were noted. In future updates, if more eligible studies are included, the impact of including studies with high levels of missing data in the overall assessment of treatment effect will be explored by using sensitivity analysis. For all outcomes, analyses were carried out, as far as possible, on an intention‐to‐treat basis, i.e. we attempted to include all participants randomised to each group in the analyses. The denominator for each outcome in each trial was the number randomised minus any participants whose outcomes were known to be missing. Assessment of heterogeneityWe assessed statistical heterogeneity in each meta‐analysis using the Tau², I² and Chi² statistics. We regarded heterogeneity as substantial if I² was greater than 30% and either Tau² was greater than zero, or there was a low P value (less than 0.10) in the Chi² test for heterogeneity. If we identified substantial heterogeneity (above 30%), we planned to explore it by prespecified subgroup analysis. Assessment of reporting biasesIn future updates, if there are 10 or more studies in the meta‐analysis we will investigate reporting biases (such as publication bias) using funnel plots. We will assess funnel plot asymmetry visually. If asymmetry is suggested by a visual assessment, we will perform exploratory analyses to investigate it. Data synthesisWe carried out statistical analysis using the Review Manager software (RevMan 2014). We used fixed‐effect meta‐analysis for combining data where it was reasonable to assume that studies were estimating the same underlying treatment effect: i.e. where trials were examining the same intervention, and the trials’ populations and methods were judged sufficiently similar, or if the number of studies was small (less than three). If there was clinical heterogeneity sufficient to expect that the underlying treatment effects differed between trials, or if substantial statistical heterogeneity was detected, we used random‐effects meta‐analysis to produce an overall summary if an average treatment effect across trials was considered clinically meaningful. The random‐effects summary was treated as the average range of possible treatment effects and we discussed the clinical implications of treatment effects differing between trials. If the average treatment effect was not clinically meaningful, we did not combine trials. If we used random‐effects analyses, the results were presented as the average treatment effect with 95% confidence intervals, and the estimates of Tau² and I². Subgroup analysis and investigation of heterogeneityIf we identified substantial heterogeneity, we planned to investigate it using subgroup analyses and sensitivity analyses and to consider whether an overall summary was meaningful, and if it was, to undertake a random‐effects analysis. Subgroup analyses were not prespecified in the earlier version of the review (Smith 2004). We planned to carry out the following subgroup analyses:
In addition, we planned to carry out the following subgroup analyses:
We planned to use the following outcome in subgroup analyses: caesarean section. However, in this update, none of subgroups specified above were analysed due to a lack of data in the prespecified subgroups. We did carry out comparisons according to subgroups by type of intervention: 1. Manual acupuncture versus electro‐acupuncture, for all outcomes. We assessed subgroup differences by interaction tests available within RevMan (RevMan 2014). We reported the results of subgroup analyses quoting the Chi² statistic and P value, and the interaction test I² value. Sensitivity analysisWhere subgroup analysis failed to explain the heterogeneity, we planned to analyse the data using a random‐effects model. A priori, we planned to perform sensitivity analysis on the results to look at the possible contribution of: (1) differences in risk of bias with trials having a low risk of bias across four or more domains compared to all trials; and (2) publication bias by country. If publication bias was present, we planned to undertake a sensitivity analysis excluding trials from countries where there was a greater publication bias. ResultsDescription of studiesSee: Characteristics of included studies; Characteristics of excluded studies; Characteristics of studies awaiting classification. Results of the searchFigure 1 outlines the search process. The previous update of this review included 14 trials, and excluded eight trials. This updated review included 22 trials and excluded 12 trials. Eight new trials were included and four new trials were excluded. Four studies are classified as ongoing. Included studiesStudy location and sources of womenThree studies were under taken in Iran (Ajori 2013; Torkzahrani 2015; Torkzahrani 2016). Two studies were undertaken in Australia (Mollart 2016; Smith 2008), Denmark (Andersen 2013; Modlock 2010), Norway (Gaudet 2008; Selmer‐Olsen 2007), the United States (Asher 2009; Harper 2006), and in the United Kingdom (Gregson 2015; Mackenzie 2011). One study was undertaken in Austria (Rabl 2001), Brazil (Gribel 2011), Canada (Gaudet 2008), China (Long 1994), Egypt (Alsharnoubi 2015), France (Tremeau 1992), Germany (Romer 2000), Italy (Neri 2014) and the Phillipines (Martinez 2004). Types of interventionsTen studies used manual acupuncture only (Ajori 2013; Asher 2009; Gaudernack 2006; Modlock 2010; Neri 2014; Rabl 2001; Romer 2000; Selmer‐Olsen 2007; Smith 2008; Tremeau 1992), one trial used laser acupuncture (Alsharnoubi 2015), one trial used electro‐acupuncture only (Gribel 2011), and three trials used manual and electro‐acupuncture (Andersen 2013; Gaudet 2008; Harper 2006). Acupressure was used in four trials (Gregson 2015; Mollart 2016; Torkzahrani 2015; Torkzahrani 2016). Gaudet 2008 used a combination of manual and nonactive electro‐stimulation for the control group. Fixed points were used in 17 trials (Ajori 2013; Alsharnoubi 2015; Andersen 2013; Asher 2009; Gaudet 2008; Gregson 2015; Gribel 2011; Harper 2006; Mackenzie 2011; Modlock 2010; Mollart 2016; Neri 2014; Rabl 2001; Romer 2000; Torkzahrani 2015; Torkzahrani 2016; Tremeau 1992) and three trials used individualised treatment (Gaudernack 2006; Selmer‐Olsen 2007; Smith 2008). Details were unclear in two trials (Long 1994; Martinez 2004). There was significant variation in the acupuncture points used but frequent acupuncture points included; Stomach 36 (ST36), Liver 3 (LR3), Conception Vessel 4 (CV4), Three Heater 6 (TH6), Large Intestine 4 (LI4), Gall Bladder 41 (GB41), Kidney 6 (KI6), Spleen 6 (SP6), Heart 7 (HT7), and Lung 7 (LU7), Bladder 31 (UB31), Bladder 32 (UB32), Bladder 60 (UB60) Bladder 67 (UB67), Governing Vessel (GV20). The number of treatments varied from three trials administering one treatment (Gaudernack 2006; Mackenzie 2011; Rabl 2001), six trials administering two treatments (Ajori 2013; Andersen 2013; Gaudet 2008; Modlock 2010; Selmer‐Olsen 2007; Smith 2008) and eight providing three or more (Alsharnoubi 2015; Asher 2009; Gribel 2011; Harper 2006; Mollart 2016; Neri 2014; Romer 2000; Tremeau 1992). The number of treatment sessions was not specified in five trials (Gregson 2015; Long 1994; Martinez 2004; Torkzahrani 2015; Torkzahrani 2016). FundingOnly seven trials provided details for their funding sources. Asher 2009 was funded by American Academy of Family Physicians, UNC Dept of Family Medicine, the NIH National Centre on Complementary and Alternative Medicine, and the UNC School of Medicine; Harper 2006 by the Bowes Cefalo Young Researcher Award and North Carolina Academic Alliance for Integrative medicine Pilot; Mackenzie 2011 by a grant from Oxfordshire Health Services Research Committee and the Uterine Contractility Trust Fund; Modlock 2010 by the Midwifery Union, Denmark, The Skejby Research Fund, Aase and Ejnar Danielsens Funds, Timber Merchant Vilhelm Bangs Fund and the County of Ringkjobing Research Fund; Mollart 2016 by the NSW Ministry of Health Nursing and Midwifery Office, Australian College of Midwives, NSW Branch and Central; Selmer‐Olsen 2007 by Sandvik forlag; and Smith 2008 was funded by the Australian National Health and Medical Research Council, the Women’s and Children’s Hospital Foundation, Adelaide, Australia. Excluded studiesTwelve studies were excluded; see Characteristics of excluded studies. Four trials were excluded because they did not describe any form of randomisation (Dorr 1990; Kubista 1974; Li 1996; SSo 1979) and we were unable to obtain details from authors. One trial was excluded due to an evaluation of acupuncture on pain relief in labour (Bo 2006). Two trials reported on women already in labour (Liu 2012; Lyngso 2010). Three trials used a form of stimulation not relevant to this review (Aghamohammadi 2011; Dunn 1989; Teimoori 2015). One trial was excluded due to examining early mid trimester labour (Li 2007). Levett 2016b used a combination of interventions including yoga, acupressure and visualisation. Separating the effect of acupressure alone was not possible. Risk of bias in included studiesSee Figure 2 and Figure 3 for a graphical summary of the 'Risk of bias' assessment by authors of the included studies based on the six domains of bias. Two studies were at a low risk of bias on all domains (Gregson 2015; Smith 2008). 'Risk of bias' graph: review authors' judgements about each risk of bias item presented as percentages across all included studies. 'Risk of bias' summary: review authors' judgements about each risk of bias item for each included study. BlindingSeventeen studies were at low risk of performance bias, with one trial having a high risk of bias (Martinez 2004), primarily because participants were not blind to group allocation in the studies using a standard care control. In the other four trials there was not enough information reported to be clear whether or not blinding had taken place (Long 1994; Modlock 2010; Torkzahrani 2015; Tremeau 1992). Detection bias was assessed at a low risk in 13 trials, one trial was assessed at high risk (Rabl 2001), and eight trials were assessed as unclear. Incomplete outcome dataSixteen trials were assessed at low risk of bias. Three trials were at high risk (Rabl 2001; Selmer‐Olsen 2007; Torkzahrani 2016). In the Rabl trial (Rabl 2001), there were 11 (20%) post‐randomisation exclusions and losses to follow‐up. There was an imbalance in the post‐randomisation exclusions (five in the treatment group and eight in the control group). The trial author was unable to provide outcome data on the 11 women who had been excluded from analyses. Risk was assessed as unclear in three trials (Alsharnoubi 2015; Long 1994; Tremeau 1992). Other potential sources of biasThe risk of bias was rated as low in 12 trials, high in one trial (Torkzahrani 2015) and unclear in the other 9 trials. Effects of interventionsSee: Table 1; Table 2; Table 3; Table 4; Table 5 Summary of findings for the main comparisonAcupuncture compared to sham control for induction of labour
Summary of findings 2Acupuncture compared to usual care for induction of labour
Summary of findings 3Acupuncture compared to sweeping of fetal membranes for induction of labour
Summary of findings 4Acupressure compared to sham control for induction of labour
Summary of findings 5Acupressure compared to usual care for induction of labour
This review included 22 trials of 3456 women, however we were only able to include data from 18 trials (2800 women) in the meta‐analysis. Because data were not available about the post‐randomisation exclusions for the Rabl 2001 trial and an intention‐to‐treat analysis could not be undertaken, the results of this trial could not be incorporated into the meta‐analysis. Primary data from the Long 1994 trial could not be obtained and no data were included in the analysis. Martinez 2004 reported on no clinically relevant outcomes. Torkzahrani 2015 reported cervical changes at 48 hours onwards and could not be included in the meta‐analysis. Studies that used a mixture of manual and electro‐acupuncture were classified as electro‐acupuncture in the subgroup analysis. Comparison 1: Acupuncture versus sham controlPrimary outcomesEight trials with 789 women reported on caesarean section and one trial with 364 women reported on serious neonatal morbidity. No trial reported on vaginal birth not achieved within 24 hours or uterine hyperstimulation with fetal heart rate (FHR) changes. Only one trial reported on maternal death, and recorded zero deaths in either group (Smith 2008). None of the other trials reported on serious maternal morbidity or death (e.g. uterine rupture, admission to intensive care unit, septicaemia). 1.1) Outcome: caesarean sectionData on caesarean section were reported from eight trials with 789 women (Analysis 1.1). Overall, there was high‐quality evidence of no clear difference in caesarean deliveries between groups (average risk ratio (RR) 0.80, 95% confidence interval (CI) 0.56 to 1.15, 8 trials, 789 women). Analysis Comparison 1 Acupuncture versus sham control, Outcome 1 Caesarean section. 1.1.1 Manual acupuncture versus sham controlSix trials (713 women) used manual acupuncture. There was no evidence of a difference in caesarean deliveries between groups (average RR 0.91, 95% CI 0.67 to 1.24, 6 trials, 713 women). 1.1.2 Electro‐acupuncture versus sham controlOne small trial (16 women) used electro‐acupuncture. There was no evidence of a difference in caesarean deliveries between groups (RR 0.78, 95% CI 0.14 to 4.23, 1 trial, 16 women). 1.1.3 Laser acupuncture versus sham controlOne small trial using laser acupuncture reported on this outcome, with evidence of a benefit for laser acupuncture in caesarean deliveries between groups (RR 0.45, 95% CI 0.26 to 0.79, 1 trial, 60 women). 1.2) Outcome: serious neonatal morbidityOnly one trial using manual acupuncture (Smith 2008) reported on this outcome (Analysis 1.2). Analysis Comparison 1 Acupuncture versus sham control, Outcome 2 Neontal seizure. 1.2.1 Manual acupuncture versus sham controlThere was low‐quality evidence of no difference in neonatal seizures between groups (RR 1.01, 95% CI 0.06 to 16.04, one trial, 364 women). 1.3) Outcome: serious maternal morbidity or deathThere was low‐quality evidence of no serious outcomes or maternal death reported in one trial (Smith 2008) (Analysis 1.13). Analysis Comparison 1 Acupuncture versus sham control, Outcome 13 Maternal death. Secondary outcomesSecondary outcomes related to measures of effectiveness, complications, and satisfaction. Trials reported on cervix unfavourable/unchanged after 12 to 24 hours; oxytocin augmentation; epidural analgesia; instrumental vaginal delivery; meconium‐stained liquor; Apgar score less than seven at five minutes; neonatal intensive care unit admission; perinatal death; postpartum haemorrhage; other maternal side‐effects; and maternal death. The following acupuncture‐specific outcomes were included: use of other induction methods; time from trial intervention to the birth of the baby; and length of labour. No trial reported on the following outcomes: uterine hyperstimulation without FHR changes; uterine rupture; neonatal encephalopathy; disability in childhood; maternal satisfaction; maternal side effects (all); maternal nausea; maternal vomiting; maternal diarrhoea; serious maternal complications; and caregiver not satisfied. 1.3) Outcome: cervical change within 12 to 24 hoursData on cervical maturation were available from three trials, with data reported in the meta‐analysis for one trial (Analysis 1.3). Overall, there was evidence of a benefit from acupuncture in increasing cervical maturity within 24 hours (MD 0.40, 95% CI 0.11 to 0.69, 1 trial, 125 women). The Bishop's score was the most common measure of cervical change used in the included trials and provided a single score that encompassed five components including; cervical dilation, cervical effacement, cervical consistency, cervical position, and fetal station. A Bishop's score of nine or greater suggested that labour would most likely commence without any need for induction methods (Tenore 2003). Analysis Comparison 1 Acupuncture versus sham control, Outcome 3 Cervical maturity within 24 hours (Bishop score). Data from the Smith 2008 trial were not included in the meta‐analysis; it reported an increase in the Bishop's score that did not differ between groups (RR 1.08, 95% CI 0.92 to 1.26, 1 trial, 364 women), data not shown. The Romer 2000 trial did not report on when the cervical change was assessed; however, the authors reported there was a significant change in the Bishop's score (acupuncture 5.9 (1.3) (mean and standard deviation (SD)), nonspecific acupuncture 4.0, (0.9), and no acupuncture 3.6 (1.0)). 1.3.1 Manual acupuncture versus sham controlOne trial (125 women) used manual acupuncture. There was greater cervical change in Bishop's score occurring within 24 hours for women receiving acupuncture compared with the sham control, (MD 0.40. 95% CI 0.11 to 0.69, 1 trial, 125 women). 1.4) Outcome: oxytocin augmentationData on this outcome were available from four trials and 833 women (Analysis 1.4). Overall, there was no evidence of a difference between groups (RR 0.97 , 95% CI 0.78 to 1.21, 4 trials, 833 women). Analysis Comparison 1 Acupuncture versus sham control, Outcome 4 Oxytocin augmentation. 1.4.1 Manual acupuncture versus sham controlThree trials (817 women) used manual acupuncture. There was no evidence of a difference in the use of oxytocin augmentation between acupuncture and sham control groups (RR 0.98, 95% CI 0.78 to 1.22, 3 trials, 817 women). 1.4.2 Electro‐acupuncture versus sham controlOne trial (16 women) used electro‐acupuncture. There was no evidence of a difference in the use of oxytocin augmentation between electro‐acupuncture and a sham control group (RR 0.93, 95% CI 0.48 to 1.80, 1 trial, 16 women) 1.5) Outcome: epidural analgesiaThis outcome was reported by five trials including 571 women (Analysis 1.5). Overall, there was no evidence of a difference between groups (RR 1.02, 95% CI 0.88 to 1.19, 5 trials, 571 women ). Analysis Comparison 1 Acupuncture versus sham control, Outcome 5 Epidural analgesia. 1.5.1 Manual acupuncture versus sham controlFour trials (555 women) used manual acupuncture. There was no evidence of a difference in the rate of epidural use between groups (RR 1.03, 95% CI 0.88 to 1.21, 4 trials, 555 women) 1.5.2 Electro‐acupuncture versus sham controlOne trial (16 women) used electro‐acupuncture.There was no evidence of a difference in the rate of epidural use between groups (RR 0.91, 95% CI 0.66 to 1.24, 1 trial, 16 women). 1.6) Outcome: instrumental vaginal birthFive trials with 610 women reported on this outcome (Analysis 1.6). Overall, there was no evidence for a benefit from acupuncture (RR 1.16, 95% CI 0.83 to 1.62, 5 trials, 610 women). Analysis Comparison 1 Acupuncture versus sham control, Outcome 6 Instrumental vaginal birth. 1.6.1 Manual acupuncture versus sham controlFour trials (594 women) used manual acupuncture. There was no evidence of a difference in the rate of instrumental delivery between groups (RR 1.18, 95% CI 0.84 to 1.65, 4 trials, 594 women). 1.6.2 Electro‐acupuncture versus sham controlOne trial (16 women) used electro‐acupuncture. There was no evidence of a difference in the rate of instrumental delivery between groups (RR 0.78, 95% CI 0.14 to 4.23, 1 trial, 16 women). 1.7) Outcome: meconium‐stained liquorOne trial using manual acupuncture (364 women) reported on this outcome (Analysis 1.7). Analysis Comparison 1 Acupuncture versus sham control, Outcome 7 Meconium‐stained liquor. There was no evidence of a difference in meconium‐stained liquor between groups (RR 0.81, 95% CI 0.56 to 1.16, 1 trial, 364 women). 1.8) Outcome: Apgar score less than seven at five minutesData on this outcome were reported by four trials (559 women) (Analysis 1.8). Overall, there was no evidence of a benefit for acupuncture (RR 0.67, 95% CI 0.20 to 2.21, 4 trials, 559 women). Analysis Comparison 1 Acupuncture versus sham control, Outcome 8 Apgar score less than seven at five minutes. 1.8.1 Manual acupuncture versus sham controlThree trials (542 women) used manual acupuncture. There was no evidence of a difference in the Apgar score at five minutes between groups (RR 0.50, 95% CI 0.13 to 2.00, 3 trials, 542 women). 1.8.2 Electro‐acupuncture versus sham controlOne trial (16 women) used electro‐acupuncture. There was no evidence of a difference in the Apgar score at five minutes between groups (RR 2.40, 95% CI 0.11 to 51.32, 1 trial, 16 women). 1.9) Outcome: neonatal intensive care unit admissionFour trials (216 women) reported on this outcome (Analysis 1.9). Overall, there was no evidence of a benefit for acupuncture (average RR 0.82, 95% CI 0.02 to 37.11, 4 trials, 216 women, I² = 72%, Tau² = 5.42). Analysis Comparison 1 Acupuncture versus sham control, Outcome 9 Neonatal intensive care unit admission. 1.9.1 Manual acupuncture versus sham controlThree trials (200 women) used manual acupuncture. There was no evidence of a difference between groups (average RR 0.11, 95% CI 0.01 to 2.15, 4 trials, 200 women). 1.9.2 Electro‐acupuncture versus sham controlOne trial (16 women) used electro‐acupuncture. There was no evidence of a difference between groups (average RR 5.60, 95% CI 0.34 to 93.35, 1 trial, 16 women). 1.10) Outcome: perinatal deathOne trial using manual acupuncture (364 women) reported on this outcome (Analysis 1.10). There were no deaths in either group. Analysis Comparison 1 Acupuncture versus sham control, Outcome 10 Perinatal death. 1.11) Outcome: maternal side effect ‐ maternal infectionOne trial using manual acupuncture (44 women) reported on this outcome (Analysis 1.11). There was no evidence of a difference between groups when using manual acupuncture (RR 1.29, 95% CI 0.43 to 3.88, 1 trial, 44 women). Analysis Comparison 1 Acupuncture versus sham control, Outcome 11 Maternal side effect ‐ Maternal infection. 1.12) Outcome: postpartum bleeding greater than 500 mLThree trials (542 women) reported on this outcome (Analysis 1.12). Analysis Comparison 1 Acupuncture versus sham control, Outcome 12 Postpartum bleeding > 500 mL. 1.12.1 Manual acupuncture versus sham controlAll three trials used manual acupuncture. There was no evidence of a difference between groups (RR 1.02, 95% CI 0.67 to 1.54, 3 trials, 542 women). 1.13) Outcome: maternal deathOne trial using manual acupuncture (364 women) reported on this outcome (Analysis 1.13). There were no maternal deaths in either group. 1.14) Outcome: time from trial intervention to the birth of the babyTwo trials (61 women) reported on this outcome (Analysis 1.14). Analysis Comparison 1 Acupuncture versus sham control, Outcome 14 Time from trial intervention to birth of baby (days; hours). 1.14.1 Manual acupuncture versus sham controlOne trial reported on this outcome (Asher 2009) and time was reported in days. There was no evidence of a clear difference in time to delivery between acupuncture and the sham control (MD 0.30, 95% CI ‐2.01 to 2.61, 1 trial, 45 women). 1.14.2 Electro‐acupuncture versus sham controlOne trial reported on this outcome (Gaudet 2008) and time was reported in hours. There was no evidence of a clear difference in time to delivery between acupuncture and the sham control (MD ‐62.00, 95% CI ‐136.99 to 12.99, 1 trial,16 women). 1.15) Outcome: use of other induction methodsFive trials (1052 women) reported on this outcome (Analysis 1.15). Overall, there was no evidence of a difference between groups (RR 1.00, 95% CI 0.88 to 1.15, 5 trials, 1052 women). Analysis Comparison 1 Acupuncture versus sham control, Outcome 15 Use of other induction methods. 1.15.1 Manual acupuncture versus sham controlFour trials (1036 women) used manual acupuncture. There was no evidence of a difference between groups (RR 1.01, 95% CI 0.88 to 1.15, 4 trials, 1036 women). 1.15.2 Electro‐acupuncture versus sham controlOne trial (16 women) used electro‐acupuncture. There was no evidence of a difference between groups (RR 0.78, 95% CI 0.29 to 2.06, 1 trial, 16 women). 1.16) Outcome: length of labourThree trials (694 women) reported on this outcome (Analysis 1.16). Overall, there was no evidence of a clear difference between groups (MD ‐36.74 minutes, 95% CI ‐125.07 to 51.59, 3 trials. 694 women, I² = 58%, Tau² = 3396.35). Analysis Comparison 1 Acupuncture versus sham control, Outcome 16 Length of labour. 1.16.1 Manual acupuncture versus sham controlTwo trials (678 women) used manual acupuncture. There was no evidence of a clear difference between groups (MD ‐20.92 minutes, 95% CI ‐127.76 to 85.92, 2 trials, 678 women, I² = 77%, Tau² = 4715.65). 1.16.2 Electro‐acupuncture versus sham controlOne trial (16 women) used electro‐acupuncture. There was no evidence of a clear difference between groups (MD ‐141.60 minutes, 95% CI ‐382.01 to 98.81, 1 trial, 16 women). 1.17) Outcome: spontaneous vaginal birthThree trials (495 women) reported on this outcome (Analysis 1.17). A random‐effects model was used due to the high heterogeneity. Overall, there was no evidence of benefit from acupuncture (RR 1.08, 95% CI 0.96 to 1.22, 3 trials, 495 women, I² = 71%, Tau² = 0.043). The test for subgroup interaction was significant (P = 0.01, I² = 84%). Analysis Comparison 1 Acupuncture versus sham control, Outcome 17 Spontaneous vaginal delivery. 1.17.1 Manual acupuncture versus sham controlTwo trials used manual acupuncture. There was no evidence of benefit of acupuncture compared to sham acupuncture (RR 1.08, 95% CI 0.96 to 1.22, 2 trials, 435 women). 1.17.2 Laser acupuncture versus sham controlOne trial reported on this outcome. There was evidence of a benefit for laser acupuncture compared to sham laser (RR 2.50, 95% CI 1.31 to 4.77, 1 trial, 60 women). Comparison 2: Acupuncture versus usual carePrimary outcomesEight trials with 760 women reported on caesarean section. No trial reported on serious neonatal morbidity; vaginal birth not achieved within 24 hours; uterine hyperstimulation with fetal heart rate (FHR) changes; and serious maternal morbidity or death (e.g. uterine rupture, admission to intensive care unit, septicaemia). 2.1) Outcome: caesarean sectionData on caesarean section were reported from eight trials with 760 women (Analysis 2.1). Overall, there was low‐quality evidence of no clear difference in caesarean deliveries between groups (average RR 0.77, 95% CI 0.51 to 1.17, 8 trials, 760 women, I² = 42%, Tau² = 0.014). The test for subgroup interaction was significant, suggesting a difference between types of acupuncture (P = 0.04, I² = 75.9%). Analysis Comparison 2 Acupuncture versus usual care, Outcome 1 Caesarean section. 2.1.1 Manual acupuncture versus usual careFive trials (433 women) used manual acupuncture. There was no evidence of a difference in caesarean deliveries between groups (average RR 1.10, 95% CI 0.63 to 1.92, 5 trials, 433 women). 2.1.2 Electro‐acupuncture versus usual careThree trials (327 women) used electro‐acupuncture. There was evidence of a benefit for electro‐acupuncture in reducing caesarean section rate (average RR 0.54, 95% CI 0.37 to 0.80, 3 trials, 327 women). Secondary outcomesSecondary outcomes related to measures of effectiveness, complications, and satisfaction. Trials reported on cervix unfavourable/unchanged after 12 to 24 hours; oxytocin augmentation; epidural analgesia; instrumental vaginal delivery; Apgar score less than seven at five minutes; neonatal intensive care unit admission; postpartum haemorrhage; other maternal side effects; maternal death; and woman not satisfied. The following acupuncture‐specific outcomes were included: use of other induction methods; time from trial intervention to the birth of the baby; and length of labour. No trial reported on the following outcomes: uterine hyperstimulation without FHR changes; uterine rupture; neonatal encephalopathy; meconium‐stained liquor; perinatal death; disability in childhood; maternal side effects (all); maternal nausea; maternal vomiting; maternal diarrhoea; serious maternal complications; and caregiver not satisfied. 2.2) Outcome: cervical change within 12 to 24 hoursData on cervical maturation were available from two trials (Gribel 2011; Harper 2006) with data reported in the meta‐analysis from one trial (Analysis 2.2). The Bishop's score was the most common measure of cervical change used in the included trials and provided a single score than encompassed five components: cervical dilation, cervical effacement, cervical consistency, cervical position, and fetal station. A Bishop's score of 9 or greater suggested that labour would most likely commence without any need for induction methods (Tenore 2003). Analysis Comparison 2 Acupuncture versus usual care, Outcome 2 Cervical maturity within 24 hours (Bishop score). 2.2.1 Electro‐acupuncture versus usual careThere was an increase in cervical maturation in the acupuncture group compared with the control (MD 1.30, 95% CI 0.11 to 2.49, 1 trial, 67 women). Data from the Harper 2006 trial were not included in the analysis; there was no difference in cervical dilatation on the day of admission using electro‐acupuncture (3.3.cm versus 2.7 cm, P = 0.28). 2.3) Outcome: oxytocin augmentationData on this outcome were available from four trials and 461 women (Analysis 2.3). Overall, there was no evidence of a difference between groups (average RR 1.10, 95% CI 0.90 to 1.34, 4 trials, 461 women). Analysis Comparison 2 Acupuncture versus usual care, Outcome 3 Oxytocin augmentation. 2.3.1 Manual acupuncture versus usual careTwo trials (190 women) used manual acupuncture. There was no evidence of a difference in the use of oxytocin augmentation between acupuncture and usual care groups (average RR 1.00, 95% CI 0.80 to 1.25, 2 trials, 190 women). 2.3.2 Electro‐acupuncture versus usual careTwo trials (271 women) used electro‐acupuncture. There was no evidence of a difference in the use of oxytocin augmentation between acupuncture and usual care groups (average RR 1.33, 95% CI 0.95 to 1.86, 2 trials, 271 women). 2.4) Outcome: epidural analgesiaThis outcome was reported by six trials and 555 women (Analysis 2.4). Overall, there was no evidence of a difference between groups (average RR 0.92, 95% CI 0.78 to 1.07, 6 trials, 555 women). Analysis Comparison 2 Acupuncture versus usual care, Outcome 4 Epidural analgesia. 2.4.1 Manual acupuncture versus usual careFour trials (284 women) used manual acupuncture. There was no evidence of a difference in the rate of epidural use between groups (average RR 0.95, 95% CI 0.76 to 1.19, 4 trials, 284 women). 2.4.2 Electro‐acupuncture versus usual careTwo trials (271 women) used electro‐acupuncture. There was no evidence of a difference in the rate of epidural use between groups (average RR 0.94, 95% CI 0.62 to 1.42, 2 trials, 271 women, I² = 60%, Tau² = 0.06). 2.5) Outcome: instrumental vaginal birthSix trials with 555 women reported on this outcome (Analysis 2.5). Overall, there was no evidence for a benefit from acupuncture (RR 1.11, 95% CI 0.62 to 1.99, 6 trials, 555 women, I² = 54%, Tau² = 0.27). The test for subgroup interaction was significant, suggesting a difference between different types of acupuncture (P = 0.04, I² = 75.3%). Analysis Comparison 2 Acupuncture versus usual care, Outcome 5 Instrumental vaginal birth. 2.5.1 Manual acupuncture versus usual careFour trials (284 women) used manual acupuncture. There was no evidence of a difference in the rate of instrumental delivery between groups (RR 0.86, 95% CI 0.45 to 1.67, 4 trials, 284 women, I² = 53%, Tau² = 0.24). No one trial appeared to contribute to the significant heterogeneity. A random‐effects model was used due to the significant heterogeneity. 2.5.2 Electro‐acupuncture versus usual careTwo trials (271 women) used electro‐acupuncture. There was evidence of benefit for usual care in the rate of instrumental delivery between groups (RR 2.30, 95% CI 1.15 to 4.60, 2 trials, 271 women). 2.6) Outcome: Apgar score less than seven at five minutesData on this outcome were reported by four trials (446 women) (Analysis 2.6). Overall, there was no evidence of a benefit for acupuncture (RR 0.34, 95% CI 0.04 to 3.20, 4 trials, 446 women). Analysis Comparison 2 Acupuncture versus usual care, Outcome 6 Apgar score less than seven at five minutes. 2.6.1 Manual acupuncture versus usual careThree trials (242 women) used manual acupuncture. There was no evidence of a difference in the Apgar score at five minutes between groups (RR 0.35, 95% CI 0.01 to 8.48, 3 trials, 242 women). 2.6.2 Electro‐acupuncture versus usual careOne trial (204 women) used electro‐acupuncture. There was no evidence of a difference in the Apgar score at five minutes between groups (RR 0.32, 95% CI 0.01 to 7.78, 1 trial, 204 women). 2.7) Outcome: neonatal intensive care unit admissionTwo trials (249 women) reported on this outcome (Analysis 2.7). Overall, there was no evidence of a benefit for acupuncture (RR 0.27, 95% CI 0.05 to 1.48, 2 trials, 249 women). Analysis Comparison 2 Acupuncture versus usual care, Outcome 7 Neonatal intensive care unit admission. 2.7.1 Manual acupuncture versus usual careOne trial (45 women) used manual acupuncture. There was no evidence of a difference between groups (RR 0.65, 95% CI 0.03 to 14.97, 1 trial, 45 women). 2.7.2 Electro‐acupuncture versus usual careOne trial (204 women) used electro‐acupuncture. There was no evidence of a difference between groups (RR 0.19, 95% CI 0.02 to 1.62, 1 trial, 204 women). 2.8) Outcome: Maternal side effect ‐ maternal infectionTwo trials (136 women) reported on this outcome (Analysis 2.8). Analysis Comparison 2 Acupuncture versus usual care, Outcome 8 Maternal side effect ‐ maternal infection. 2.8.1 Manual acupuncture versus usual careTwo trials (136 women) used manual acupuncture. There was no evidence of a difference between groups (RR 1.64, 95% CI 0.43 to 6.32, 2 trials, 136 women). 2.9) Outcome: Maternal side effect ‐ perineal tearOne trial using manual acupuncture (91 women) reported on this outcome (Analysis 2.9). Analysis Comparison 2 Acupuncture versus usual care, Outcome 9 Maternal side effect ‐ perineal tear. 2.9.1 Manual acupuncture versus usual careThere was no evidence of a difference in this outcome between groups (RR 1.22, 95% CI 0.95 to 1.56, 1 trial, 91 women). 2.10) Outcome: Maternal side effect ‐ fetal infectionOne trial using manual acupuncture (91 women) reported on this outcome (Analysis 2.10). Analysis Comparison 2 Acupuncture versus usual care, Outcome 10 Maternal side effect ‐ fetal infection. 2.10.1 Usual careThere were no reports of fetal infection between groups. 2.11) Outcome: postpartum bleeding greater than 500 mLTwo trials (256 women) women reported on this outcome (Analysis 2.11). Overall, there was no evidence of a difference in this outcome between groups (RR 0.81, 95% CI 0.36 to 1.81, 2 trials, 256 women). Analysis Comparison 2 Acupuncture versus usual care, Outcome 11 Postpartum bleeding > 500 mL. 2.11.1 Manual acupuncture versus usual careOne trial (52 women) used manual acupuncture. There was no evidence of a difference between groups (RR 0.50, 95% CI 0.10 to 2.50, 1 trial, 52 women). 2.11.2 Electro‐acupuncture versus usual careOne trial (204 women) used electro‐acupuncture. There was no evidence of a difference between groups (RR 0.96, 95% CI 0.38 to 2.46, 1 trial, 204 women). 2.12) Outcome: time from trial intervention to the birth of the babyTwo trials (100 women) reported on this outcome (Analysis 2.12). Analysis Comparison 2 Acupuncture versus usual care, Outcome 12 Time from trial intervention to birth of baby (days; hours). 2.12.1 Manual acupuncture versus usual careOne trial reported on this outcome (Asher 2009). This outcome was measured in days by Asher 2009. Evidence of a benefit for usual care in reducing time to birth of the baby was found (MD 2.90, 95% CI 0.66 to 5.14; 1 trial, 44 women).
2.12.2 Electro‐acupuncture versus usual careOne trial reported on this outcome (Harper 2006). This outcome was measured in hours by Harper 2006. There was no evidence of a difference between groups (MD ‐21.00, 95% CI ‐64.43 to 22.43, 1 trial, 56 women). 2.13) Outcome: maternal satisfactionOne trial using electro‐acupuncture (67 women) reported on this outcome, (Analysis 2.13). Analysis Comparison 2 Acupuncture versus usual care, Outcome 13 Maternal satisfaction. 2.13.1 Electro‐acupuncture versus usual careThere was no evidence of a difference in maternal satisfaction between groups (RR 1.29, 95% CI 0.99 to 1.67, 1 trial, 67 women). 2.14) Outcome: use of other induction methodsFour trials (259 women) reported on this outcome (Analysis 2.14). Overall, there was no evidence of a difference between groups (average RR 1.00, 95% CI 0.69 to 1.45, 4 trials, 259 women, I² = 45%, Tau² = 0.06) Analysis Comparison 2 Acupuncture versus usual care, Outcome 14 Use of other induction methods. 2.14.1 Manual acupuncture versus usual careTwo trials (136 women) used manual acupuncture. There was no evidence of a difference between groups (average RR 0.95, 95% CI 0.62 to 1.45, 2 trials, 136 women) 2.14.2 Electro‐acupuncture versus usual careTwo trials (123 women) used electro‐acupuncture. There was no evidence of a difference between groups (average RR 0.96, 95% CI 0.41 to 2.23, 2 trials, 123 women, I² = 80%,Tau² = 0.30) 2.15) Outcome: length of labourTwo trials (269 women) reported on this outcome; one trial (67 women) were included in the meta‐analysis (Analysis 2.15). Analysis Comparison 2 Acupuncture versus usual care, Outcome 15 Length of labour. In one trial using electro‐acupuncture (Gribel 2011), there was evidence that the length of labour (in minutes) was shorter in the usual care group compared with acupuncture (MD 124.00 minutes, 95% CI 37.39 to 210.61, 1 trial, 67 women). One trial using manual acupuncture (Neri 2014) reported data by parity. There was no evidence of a difference in the length of the first stage of labour between groups for both nulliparous women, acupuncture 337 (mean) (99 (SD)) minutes versus usual care 354 (112) minutes and multiparous women, acupuncture 138 (79) minutes versus usual care 179 (93) minutes. There was evidence of a benefit for usual care for nulliparous women in the second stage of labour, acupuncture 58 (30) minutes versus usual care 43.14 (26.3) minutes. 2.16) Outcome: spontaneous vaginal birthTwo trials (117 women) reported on this outcome (Analysis 2.16). A random‐effects model was used due to the high heterogeneity. Overall, there was no evidence of benefit from acupuncture (average RR 1.44, 95% CI 0.70 to 2.98, 2 trials, 117 women, I² = 68.1%, Tau² = 0.23). The test for subgroup interaction was significant, suggesting a difference between different types of acupuncture (P = 0.04, I² = 76.2%). Analysis Comparison 2 Acupuncture versus usual care, Outcome 16 Spontaneous vaginal delivery. 2.16.1 Manual acupuncture versus usual careOne trial (45 women) used manual acupuncture. There was no evidence of benefit of acupuncture compared to usual care (RR 1.07, 95% CI 0.77 to 1.47, 1 trial, 45 women). 2.16.2 Electro‐acupuncture versus usual careOne trial (72 women) used electro‐acupuncture. There was evidence of a benefit of electro‐acupuncture compared to usual care (RR 2.06, 95% CI 1.20 to 3.56, 1 trial, 72 women). Comparison 3: Acupuncture versus sweeping of fetal membranesPrimary outcomesOne trial with 207 women reported on caesarean section. No trial reported on serious neonatal morbidity; vaginal delivery not achieved within 24 hours; uterine hyperstimulation with fetal heart rate (FHR) changes; and serious maternal morbidity or death (e.g. uterine rupture, admission to intensive care unit, septicaemia). 3.1) Outcome: caesarean sectionData on caesarean section were reported from one trial with 207 women (Analysis 3.1). One trial using electro‐acupuncture reported on this outcome, with moderate‐quality evidence of no clear difference in caesarean deliveries between groups (RR 0.64, 95% CI 0.34 to 1.22, 1 trial, 207 women). Analysis Comparison 3 Acupuncture versus sweeping of fetal membranes, Outcome 1 Caesarean section. Secondary outcomesSecondary outcomes related to measures of effectiveness, complications, and satisfaction. Trials reported on oxytocin augmentation; epidural analgesia; instrumental vaginal birth; Apgar score less than seven at five minutes; neonatal intensive care unit admission; and postpartum haemorrhage. No trial reported on the following outcomes: cervix unfavourable/unchanged after 12 to 24 hours; uterine hyperstimulation without FHR changes; uterine rupture; perinatal death; meconium‐stained liquor; neonatal encephalopathy; disability in childhood; other maternal side effects; maternal death; woman not satisfied; maternal side effects (all); maternal nausea; maternal vomiting; maternal diarrhoea; serious maternal complications; and caregiver not satisfied.The following acupuncture‐specific outcomes were not reported: use of other induction methods; time from trial intervention to the birth of the baby; and length of labour. 3.2) Outcome: oxytocin augmentationOne trial using electro‐acupuncture reported on this outcome (Analysis 3.2). There was no evidence of a difference in the use of oxytocin augmentation between acupuncture and sweeping of the fetal membrane groups (RR 0.90, 95% CI 0.66 to 1.24, 1 trial, 207 women). Analysis Comparison 3 Acupuncture versus sweeping of fetal membranes, Outcome 2 Oxytocin augmentation. 3.3) Outcome: epidural analgesiaOne trial using electro‐acupuncture reported on this outcome (Analysis 3.3). There was no evidence of a difference in the rate of epidural use between groups (RR 0.96, 95% CI 0.61 to 1.49, 1 trial, 207 women). Analysis Comparison 3 Acupuncture versus sweeping of fetal membranes, Outcome 3 Epidural analgesia. 3.4) Outcome: instrumental vaginal deliveryOne trial using electro‐acupuncture reported this outcome (Analysis 3.4). There was no evidence of a difference in the rate of instrumental delivery between groups (RR 1.68, 95% CI 0.89 to 3.14, 1 trial, 207 women). Analysis Comparison 3 Acupuncture versus sweeping of fetal membranes, Outcome 4 Instrumental vaginal birth. 3.5) Outcome: Apgar score less than seven at five minutesOne trial using electro‐acupuncture reported on this outcome. There we no Apgar scores less than seven occurring in either group, (Analysis 3.5). Analysis Comparison 3 Acupuncture versus sweeping of fetal membranes, Outcome 5 Apgar score less than seven at five minutes. 3.6) Outcome: neonatal intensive care unit admissionOne trial using electro‐acupuncture reported on this outcome (Analysis 3.6). There was no evidence of a difference between groups (RR 0.33, 95% CI 0.03 to 3.12, 1 trial, 207 women). Analysis Comparison 3 Acupuncture versus sweeping of fetal membranes, Outcome 6 Neonatal intensive care unit admission. 3.7) Outcome: postpartum bleeding greater than 500 mLOne trial using electro‐acupuncture reported on this outcome (Analysis 3.7). There was no evidence of a difference in the rate of instrumental delivery between groups (RR 1.32, 95% CI 0.47 to 3.67, 1 trial, 207 women). Analysis Comparison 3 Acupuncture versus sweeping of fetal membranes, Outcome 7 Postpartum bleeding > 500 mL. Comparison 4: Acupressure versus sham controlPrimary outcomesTwo trials reported on one primary outcome only: caesarean section. No trial reported on serious neonatal morbidity; vaginal delivery not achieved within 24 hours; uterine hyperstimulation with FHR changes; and serious maternal morbidity or death (e.g. uterine rupture, admission to intensive care unit, septicaemia). 4.1) Outcome: caesarean sectionData on caesarean section were reported from two trials with 239 women (Analysis 4.1). Analysis Comparison 4 Acupressure versus sham control, Outcome 1 Caesarean section. There was moderate‐quality evidence of no clear difference in caesarean deliveries between groups (RR, 0.94, 95% CI 0.68 to 1.30, 2 trials, 239 women). Secondary outcomesSecondary outcomes related to measures of effectiveness, complications, and satisfaction. Trials reported on oxytocin augmentation; instrumental vaginal birth; and meconium‐stained liquor. The following acupuncture‐specific outcomes were included: time from trial intervention to the birth of the baby. No trial reported on the following outcomes: cervix unfavourable/unchanged after 12 to 24 hours; epidural analgesia; perinatal death; postpartum haemorrhage; other maternal side effects; maternal death; woman not satisfied; Apgar score less than seven at five minutes; neonatal intensive care unit admission; uterine hyperstimulation without FHR changes; uterine rupture; neonatal encephalopathy; disability in childhood; maternal side effects (all); maternal nausea; maternal vomiting; maternal diarrhoea; serious maternal complications; caregiver not satisfied; and length of labour. No trial reported on the acupuncture‐specific outcome: use of other induction methods. 4.2) Outcome: oxytocin augmentationOne trial (Gregson 2015) reported on this outcome (Analysis 4.2). There was no evidence of a difference in the use of oxytocin augmentation between acupressure and a sham control group (RR 1.42, 95% CI 0.96 to 2.08, 1 trial, 130 women). Analysis Comparison 4 Acupressure versus sham control, Outcome 2 Oxytocin augmentation. 4.3) Outcome: instrumental vaginal birthOne trial (Gregson 2015) reported on this outcome (Analysis 4.3). There was no evidence of a difference in the rate of instrumental delivery between groups (RR 1.12, 95% CI 0.59 to 2.11, 1 trial, 130 women). Analysis Comparison 4 Acupressure versus sham control, Outcome 3 Instrumental vaginal birth. 4.4) Outcome: meconium‐stained liquorOne trial (Gregson 2015) reported on this outcome (Analysis 4.4). There was no evidence of a difference in meconium‐stained liquor between groups (RR 1.45, 95% CI 0.80 to 2.62, 1 trial, 130 women). Analysis Comparison 4 Acupressure versus sham control, Outcome 4 Meconium‐stained liquor. 4.5) Outcome: time from trial intervention to birth of the babyOne trial (Torkzahrani 2016) reported this outcome in hours (Analysis 4.5). Analysis Comparison 4 Acupressure versus sham control, Outcome 5 Time from trial intervention to birth of baby (hours). There was no evidence of a difference in time to delivery between groups (MD ‐10.51, 95% CI ‐37.96 to 16.94, 1 trial, 109 women). 4.6) Outcome: spontaneous vaginal deliveryTwo trials reported on this outcome (Analysis 4.6). There was no evidence of a benefit from acupressure compared to sham (RR 1.04, 95% CI 0.79 to 1.36, 2 trials, 239 women). Analysis Comparison 4 Acupressure versus sham control, Outcome 6 Spontaneous vaginal delivery. Comparison 5: Acupressure versus usual carePrimary outcomesTwo trials reported on one primary outcome only: caesarean section. No trial reported on serious neonatal morbidity; vaginal birth not achieved within 24 hours; uterine hyperstimulation with FHR changes; and serious maternal morbidity or death (e.g. uterine rupture, admission to intensive care unit, septicaemia). 5.1) Outcome: caesarean sectionData on caesarean section were reported from two trials with 151 women (Analysis 5.1). Overall. there was moderate‐quality evidence of no clear differences between groups (RR 1.02, 95% CI 0.68 to 1.53, 2 trials, 151 women). A fixed‐effects model was used, due to the small number of studies included in this comparison. Analysis Comparison 5 Acupressure versus usual care, Outcome 1 Caesarean section. Secondary outcomesSecondary outcomes related to measures of effectiveness, complications, and satisfaction. Trials reported on epidural analgesia; Apgar score less than seven at five minutes; and neonatal intensive care unit admission. The following acupuncture‐specific outcomes were included: use of other induction methods, and time from trial intervention to the birth of the baby. No trial reported on the following outcomes: cervix unfavourable/unchanged after 12 to 24 hours; oxytocin augmentation; instrumental vaginal delivery; meconium‐stained liquor; perinatal death; postpartum haemorrhage; other maternal side effects; maternal death; woman not satisfied; uterine hyperstimulation without FHR changes; uterine rupture; neonatal encephalopathy; disability in childhood; maternal side effects (all); maternal nausea; maternal vomiting; maternal diarrhoea; serious maternal complications; caregiver not satisfied; and length of labour. 5.2) Outcome: epidural analgesiaOne trial (Mollart 2016) reported on this outcome (Analysis 5.2). There was no evidence of a difference in the rate of epidural use between groups (RR 0.91, 95% CI 0.49 to 1.69, 1 trial, 44 women). Analysis Comparison 5 Acupressure versus usual care, Outcome 2 Epidural analgesia. 5.3) Outcome: Apgar score less than seven at five minutesOne trial (Mollart 2016) reported on this outcome (Analysis 5.3).There was no evidence of a difference in the Apgar score at five minutes between groups (RR 3.00, 95% CI 0.13 to 69.87, 1 trial, 44 women). Analysis Comparison 5 Acupressure versus usual care, Outcome 3 Apgar score less than seven at five minutes. 5.4) Outcome: neonatal intensive care unit admissionOne trial (Mollart 2016) reported on this outcome (Analysis 5.4). Analysis Comparison 5 Acupressure versus usual care, Outcome 4 Neonatal intensive care unit admission. There was no evidence of a difference between groups (RR 0.60, 95% CI 0.16 to 2.21, 1 trial, 44 women). 5.5) Outcome: time from trial intervention to birth of the babyOne trial (Torkzahrani 2016) reported on this outcome in hours (Analysis 5.5). Analysis Comparison 5 Acupressure versus usual care, Outcome 5 Time from trial intervention to birth of baby (hours). There was no evidence of a difference in time to delivery between groups (MD 10.72, 95% CI ‐14.00 to 35.44, 1 trial, 107 women). 5.6) Outcome: use of other induction methodsOne trial (Mollart 2016) reported on this outcome (Analysis 5.6). Analysis Comparison 5 Acupressure versus usual care, Outcome 6 Use of other induction methods. There was no evidence of a difference between groups (RR 1.22, 95% CI 0.64 to 2.35, 1 trial, 44 women). 5.7) Outcome: spontaneous vaginal birthTwo trials reported on this outcome (Analysis 5.7). There was no evidence of a benefit from acupressure compared to usual care (RR 0.97, 95% CI 0.69 to 1.34, 2 trials, 151 women, I² = 37%, Tau² = 0.02). Analysis Comparison 5 Acupressure versus usual care, Outcome 7 Spontaneous vaginal birth. Data from other studiesIn the Rabl trial (Rabl 2001), 11 (20%) women were post‐randomisation exclusions and proceeded to have an elective induction of labour. In the acupuncture group, labour was induced for one woman because of fetal heart abnormalities and two inductions were performed due to pre‐labour rupture of membranes. In the control group, two women requested an elective induction of labour, three women received an induction of labour because of pre‐labour rupture of membranes, and in three women, labour was induced due to abnormal FHR patterns. Because data were not available about the post‐randomisation exclusions and an intention‐to‐treat analysis could not be undertaken, no results could be incorporated into this review. In Torkzahrani 2015, changes in the Bishop's score were measured after self‐applied or researcher‐applied acupressure compared to usual care. Changes in Bishop's score were measured at 48 and 96 hours and at presentation to hospital. No data were provided on Bishop's scores at 12 or 24 hours and therefore could not be incorporated into the meta‐analysis. The authors reported that at 48 hours there was a significant difference in Bishop's score (mean and (standard deviation)) between acupressure performed by the researcher 4.88 (1.83), acupressure performed by the mother 5.12 (1.92) and usual care 4.06 (1.59). This difference between groups was also significant at the time of hospital admission, acupressure performed by the researcher 5.95 (2.02), acupressure performed by the mother 6.02 (1.68) and usual care 5.02 (2.03). Sensitivity analysisIt was proposed to undertake a sensitivity analysis on the results to look at the possible contribution of: (1) differences in risk of bias with trials having a low risk of bias across four or more domains compared to all trials; and (2) publication bias by country. Neither was able to be done due to the small number of trials overall. Subgroup analysisWe were unable to undertake the planned subgroup analysis due to fewer than five trials reporting on the outcome of interest. We did however carry out comparisons according to subgroups by type of intervention, manual acupuncture versus electro‐acupuncture, for all outcomes where possible. DiscussionSummary of main resultsFindings from this review were based on comparisons between acupuncture and 11 sham‐controlled trials, and comparisons between acupuncture with 15 trials using usual care controls, or usual care plus sham. Evidence from 22 trials with data reporting on 3456 women suggested very limited benefit from acupuncture to induce labour. There was overall no evidence of benefit for acupuncture or acupressure to reduce the need for caesarean section. Subgroup analysis suggested a benefit from electro‐acupuncture for reducing caesarean section rate when compared to usual care. The majority of trials did not report on any other primary outcome. There was evidence of a benefit from acupuncture with increasing cervical maturity within 24 hours compared to usual care and to sham control. Data on cervical ripening provided conflicting results to those trials that were not included in the meta‐analysis. Four trials used changes in Bishop's scores (Romer 2000; Smith 2008; Torkzahrani 2015; Tremeau 1992) and one used cervical dilatation (Harper 2006). Compared to usual care, acupuncture showed a greater progression in both Bishop's score (Tremeau 1992) and cervical dilatation (Harper 2006). There was no change in Bishop's score when compared to sham control (Smith 2008). One acupressure trial (Torkzahrani 2015) found that cervical ripening (measured via Bishop's score) was increased in both acupressure groups versus usual care. Overall, trials were characterised by heterogenous acupuncture/acupressure point selection and dosage. There was no evidence of benefit for acupressure for any of the primary or secondary outcomes. Although there have been more trials reported evaluating the role of acupuncture since this review was last updated, there continues to be a relatively small number of trials that have provided relevant health outcomes. This limits the power of the review to detect meaningful differences between groups and analyses, suggesting these limited benefits should be interpreted with caution. Overall completeness and applicability of evidenceTrials recruited low‐risk nulliparous and primiparous women at term. The majority of trials reported that women who were offered the opportunity to participate in the trial agreed to participate. Smith 2008, however, reported that 18% of women approached declined participation due to a lack of interest in acupuncture. The systematic review documented wide variation in the delivery of acupuncture and acupressure. This included the mode of stimulation, duration of needling/pressure, number of points used, depth of needling, number of times pressure was applied per day, and duration of the trial. It is unclear how representative the treatment protocols that were used in the research are generalisable to acupuncture, as it is usually practiced. There was insufficient reporting of the rationale of the acupuncture used in the research setting. Some trials used a fixed approach to the selection of points whilst other used a flexible approach, with selection of acupuncture points based on their clinical presentation. The variation in the duration, frequency, and selection of acupuncture points suggests that the acupuncture may not have been therapeutically effective and, in some cases, may not represent best clinical practice. The variation may also reflect the country context in which acupuncture is practiced. Quality of the evidenceThe 'Risk of bias' tables (Figure 2; Figure 3) demonstrated that acupuncture has not been subjected to consistent rigorous study, however, the quality of reporting seems to be improving. Only two trials were assessed at a low risk of bias across all domains. The majority of studies were at a low risk of bias in respect to randomisation. Rates of attrition in the majority of trials were low with only three trials rated at a high risk of bias. The majority of trials were at a low risk of detection bias. Most trials were at a low risk for blinding due to the use of objective outcome measures and/or the use of blinded assessors. Only one of the sham acupuncture controlled trials used a non‐penetrating needle, however, these were placed at active acupuncture points and, therefore, may be associated with some physiological activity. The methodological quality of studies was also influenced by small sample sizes, with many studies underpowered to detect changes between groups. We assessed the quality of the evidence for the outcomes presented in five 'Summary of findings' tables using GRADE (see Table 1; Table 2; Table 3; Table 4; Table 5). We were only able to assess the quality of the evidence for one GRADE outcome: caesarean section. Overall, the evidence ranged from low to high quality. Reasons for downgrading included limitations in studies, small sample sizes, and wide confidence intervals. Potential biases in the review processWe attempted to minimise publication bias. Our search was comprehensive and we included studies identified in languages other than English. However, we cannot rule out the possibility that some studies may have been missed. We acknowledge other foreign language databases have not been searched and there is a potential that some studies have not been identified. Agreements and disagreements with other studies or reviewsTwo recent systematic reviews have examined the role of acupressure on onset and duration of labour (Makvandi 2016; Mollart 2015). Both reviews focused on studies that included women in active labour, once contractions had onset, which are excluded by our review protocol. Makvandi 2016 included 13 studies, while Mollart 2015 included a subset of seven of these trials. Both reviews concluded that acupressure during active labour showed benefits in reducing the duration of labour, while Makvadi also found that it increased the likelihood of vaginal delivery. There were no overlap between studies included in Makvandi 2016 or Mollart 2015 and this review. One systematic review examining the effect of acupuncture on induction of labour and cervical maturation found all studies demonstrated labour induction by acupuncture treatment (Lim 2009). The review included 10 studies consisting of randomised controlled trials, nonrandomised studies with and without controls, and a matched pair study. The review by Lim et al concluded a definitive role for acupuncture was still to be established and further research was needed. A recent systematic review of methods of induction of labour included our earlier Cochrane review (Smith 2004), and three other randomised controlled trials published since the 2004 Cochrane review (Mozurkewich 2011). The authors concluded that acupuncture for induction of labour is investigational, and no advantages have been demonstrated. Overall, all reviews identify there is insufficient evidence of a benefit from acupuncture. Authors' conclusionsImplications for practiceAcupuncture does not appear to reduce the need for caesarean section but may improve the cervical readiness for labour. There was no evidence of benefit from acupressure in non‐labouring women. The main limitations were limited reporting of health outcomes. Acupuncture and acupressure appear safe and the review suggests some potential benefit, however the specific timing and how many treatments remain unclear. Implications for researchVery few studies reported on the range of primary outcomes included in this review. Further research is required. We suggest future research additionally focuses on gaining a greater understanding of the specific components of acupuncture treatment in relation to working with women during the third trimester, particularly those who are approaching term, and at term. Appropriately powered randomised trials are required to examine the effectiveness of acupuncture on the clinical outcomes described in this review, especially in regards to the timing of measurements of cervical change, such as Bishop's score. Further research could compare acupuncture or acupressure with common conventional methods of induction of labour. What's new
HistoryProtocol first published: Issue 2, 2000
AcknowledgementsWe acknowledge the French to English translation by Peter Smith, the Chinese to English translation by Aidan Tan, and the German to English translation by Richmal Oates‐Whitehead, with additional translation by Gerald Muench, Julie Brown for data extraction of the Smith 2008 trial, and Xun Li for her assistance in attempted contact with Chinese authors and translations. We acknowledge, with gratitude, the significant contribution that Caroline Crowther made to the original version of this review and each subsequent update. Suzanne Grant contributed to the previous update of this review. As part of the pre‐publication editorial process, this review has been commented on by two peers (an editor and referee who is external to the editorial team), a member of the Pregnancy and Childbirth Group's international panel of consumers, and the Group's Statistical Adviser. This project was supported by the National Institute for Health Research, via Cochrane Infrastructure funding to Cochrane Pregnancy and Childbirth. The views and opinions expressed therein are those of the authors and do not necessarily reflect those of the Systematic Reviews Programme, NIHR, NHS, or the Department of Health. AppendicesAppendix 1. Search StrategiesPubMed1. exp Acupuncture Therapy (10724) 2. exp Medicine, East Asian Traditional (3238) 3. exp Acupuncture/ (15070) 4. (acupuncture or acupressure or acupoint* or electroacupuncture or electro‐acupuncture or TENS 5. 1 OR 2 OR 3 OR 4 (32010) 6. exp induction of labour (1496) 7. exp labour (21925) 8. labo?r 9. 6 OR 7 OR 8 10. 5 AND 9 (101) 11. randomized controlled trial.pt. 12. controlled clinical trial.pt. 13. randomized.ab. 14. placebo.ab. 15. drug therapy.fs. 16. randomly.ab. 17. trial.ab. 18. groups.ab. 19. 11 or 12 or 13 or14 or 15 or 16 or 17 or 18 20. 10 AND 20 (31) CINAHL Plus search strategy1. (MH "Acupuncture+") OR (MH "Acupuncture Points") OR (MH "Acupuncture, Ear") OR (MH "Acupuncturists") OR (MH "Acupuncture Analgesia") 2. electroacupuncture OR electro‐acupuncture 3. acupressure OR acupoint* OR TENS 4. #1 OR #2 OR #3 (10,266) 5. (MH "Labor, Induced+") OR (MH "Labor Stage, First") OR (MH "Labor Stage, Second") OR (MH "Labor Stage, Third") OR (MH "Labor Support") 6. Caesarean OR Pregnancy OR uterine cervix ripening OR Prostaglandin OR intravaginal drug administration OR Oxytocin OR misoprostol OR labo*r induction OR induction of labo*r 7. #5 OR #6 (113,359) 8. (MM "Randomized Controlled Trials") OR (MM "Clinical Trials+") 9. randomized controlled trial.pt. OR controlled clinical trial.pt. OR randomized.ab. OR placebo.ab. OR drug therapy.fs. OR randomly.ab. OR trial.ab. OR groups.ab. 10. #8 OR #9 (146,052) 11. #4 AND #7 AND #10 (118) Embase search strategy1. exp acupuncture analgesia/ 2. acupuncture.mp. 3. exp acupuncture/ 4. exp acupuncture needle/ 5. electroacupuncture OR electro‐acupuncture 6. acupressure OR acupoint* OR TENS 7. 1 OR 2 OR 3 OR 4 OR 5 OR 6 (39862) 8. cesarean section/ or pregnancy/ or prostaglandin/ or intravaginal drug administration/ or oxytocin/ or uterine cervix ripening/ or prostaglandin E2/ or misoprostol/ or labor induction/ or induction of labour.mp. or prostaglandin derivative/ (732108) 9. 7 AND 8 (1165) 10. Limited to Human and yr=2012 (59) 11. Randomization.mp/ or controlled clinical trial.pt. / or double blind procedure/ or randomized controlled trials.mp or (topic)/ or random allocation.mp. / or double blind method.sh. / or meta analysis/ or single‐blind method.sh. / or single blind procedure/ or clinical trial.pt. 12. 11 AND 9 (16) Dissertations and Theses A&I (ProQuest)Acupuncture AND [labour OR labor] in Title, Subject, Abstract WHO International Clinical Trials Registry Platform (ICTRP)Acupuncture OR acupressure AND (labour OR labor) NotesNew search for studies and content updated (conclusions changed) Data and analysesComparison 1Acupuncture versus sham control
Comparison 2Acupuncture versus usual care
Comparison 3Acupuncture versus sweeping of fetal membranes
Comparison 4Acupressure versus sham control
Comparison 5Acupressure versus usual care
Characteristics of studiesCharacteristics of included studies [ordered by study ID]
Characteristics of excluded studies [ordered by study ID]
Characteristics of ongoing studies [ordered by study ID]
Differences between protocol and reviewMethods were updated to current Cochrane Pregnancy and Childbirth Group standard text. Normal vaginal delivery was added as a secondary outcome measure in this update. In this update, we added the following planned subgroup analyses to the methods.
In this 2017 update, the control comparisons of sham acupuncture and usual care appeared as separate comparisons, rather than subgroups of the same comparison. Contributions of authorsCaroline Smith conceptualised and took the lead in writing the protocol, the original review, and subsequent updates. She performed initial searches of databases for trials, was involved in selecting trials for inclusion, performed data extraction and quality assessment of the included trials, was responsible for statistical analysis and interpretation of the data, and wrote the first draft of this update. Mike Armour was involved in searching databases for trials, selection and screening of trials, data extraction and quality assessment of trials. He performed the statistical analysis on this update and provided editing and contribution to both the draft and final version of this updated manuscript. Hannah Dahlen was involved in editing both the draft and final version of this manuscript. Sources of supportInternal sources
External sources
Declarations of interestCaroline Smith: is an author of one of the included trials (Smith 2008), and so a third independent person assessed and extracted data for this trial. Mike Armour: is an acupuncturist recently involved in clinical practice and the director of an acupuncture clinic. Hannah Dahlen: none known. ReferencesReferences to studies included in this reviewAjori 2013 {published data only}
Alsharnoubi 2015 {published data only}
Andersen 2013 {published data only}
Asher 2009 {published data only}
Gaudernack 2006 {published data only}
Gaudet 2008 {published data only}
Gregson 2015 {published data only}
Gribel 2011 {published data only}
Harper 2006 {published data only}
Long 1994 {published data only}
Mackenzie 2011 {published data only}
Martinez 2004 {published data only}
Modlock 2010 {published data only}
Mollart 2016 {published data only}
Neri 2014 {published data only}
Rabl 2001 {published data only}
Romer 2000 {published data only}
Selmer‐Olsen 2007 {published data only}
Smith 2008 {published data only}
Torkzahrani 2015 {published data only}
Torkzahrani 2016 {published data only}
Tremeau 1992 {published data only}
References to studies excluded from this reviewAghamohammadi 2011 {published data only}
Bo 2006 {published data only}
Dorr 1990 {published data only}
Dunn 1989 {published data only}
Kubista 1974 {published data only}
Levett 2016b {published data only}
Li 1996 {published data only}
Li 2007 {published data only}
Liu 2012 {published data only}
Lyngso 2010 {published data only}
So 1979 {published data only}
Teimoori 2015 {published data only}
References to ongoing studiesNCT00379327 {published data only}
NCT01052857 {published data only}
NCT02392988 {published data only}
NCT02394041 {published data only}
Additional referencesAdams 2009
Alfirevic 2006
Alfirevic 2009
Bell 1972
Bimbashi 2012
Boulvain 2005
Boulvain 2008
Bricker 2000
Curtis 1987
De Miranda 2006
French 2001
Ghosh 2016
Hapangama 2009
Higgins 2011
Hofmeyr 2009
Hofmeyr 2010
Howarth 2001
Hutton 2001
Jozwiak 2012
Kavanagh 2001
Kavanagh 2005
Kavanagh 2006a
Kavanagh 2006b
Kelly 2001b
Kelly 2009
Kelly 2013
Khireddine 2013
Kubista 1975
Levett 2016a
Liao 1979
Lim 2009
Luckas 2000
Makvandi 2016
Mollart 2015
Mozurkewich 2011
Muzonzini 2004
RevMan 2014 [Computer program]
Smith 2003
Smith 2004
Stewart 2014
Streitberger 1998
Tempfeer 1998
Tenore 2003
Theobald 1973
Thomas 2001
Tsuei 1974
Tsuei 1977
Yip 1976
References to other published versions of this reviewSmith 2004a
Smith 2013
Articles from The Cochrane Database of Systematic Reviews are provided here courtesy of Wiley How long after acupuncture do you go into labour?Other research reveals that the average time from acupuncture induction until delivery was 13.1 hours and the success rate of acupuncture to induce overdue labour to be between 68-83% (9). Other research articles suggest that acupuncture may help alleviate symptoms associated with pregnancy and the labour journey.
How many acupuncture sessions does it take to induce labor?Starting acupuncture around 36 weeks - weekly until week 40 (assuming you have no major pain or issues that need more symptomatic relief), then every 2-3 days. 2. Starting acupuncture around 38 weeks - twice weekly until week 40, then every 2-3 days.
Can acupuncture induce labor at 37 weeks?No trials have found that acupuncture or acupressure (using thumbs or fingers to apply pressure to specific points) initiate labor faster; in fact, a handful of trials have found that women who receive acupressure or acupuncture late in their third trimesters do not give birth any sooner than women who don't.
Where do acupuncture needles go to induce labor?Acupuncture procedure
BL67. This point, it is claimed, can be used to stimulate uterine contractions; it is located on the little toe, near the edge of the nail, and the needle is inserted to a depth of 0.1–0.2 cm.
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