In 3–5% of pregnancies, the fetus is in breech presentation at term.1 In 2000, the results of the Term Breech Trial demonstrated a clear benefit for elective caesarean delivery on perinatal morbidity that had a rapid effect on the management of breech delivery in many settings, including our hospital.2–4 Despite the publication of longer term results showing no differences in children’s outcomes between the two modes of delivery, most couples now choose an elective caesarean delivery in the case of breech presentation.5
External cephalic version is recommended to avoid the risk associated with vaginal breech delivery and caesarean delivery, but this intervention is not available in all centers and succeeds in only about 30–80% of cases.6,7 The procedure also may be painful for the patient and stressful for the couple.8 Accidents, such as umbilical cord entanglement or abruptio placentae, are rare but may require an emergency caesarean delivery.9 For this reason, external cephalic version generally is not attempted before 37 weeks of gestation to avoid preterm delivery in the case of complications. In our hospital, external cephalic version is attempted in only 60% of women owing to contraindications to the procedure or the patient’s refusal.
Systematic reviews have evaluated the efficacy, acceptability, and side effects of various alternative medical interventions proposed to improve the likelihood of a cephalic presentation, such as osteopathy and hypnosis.10 Postural techniques, including knee-chest position and supine position with the pelvis elevated, also are proposed, but there is no evidence of the efficacy of these techniques.11,12 Of note, none of these interventions has been evaluated in randomized trials.10
In Chinese traditional medicine, the stimulation of acupuncture point number 67 of the bladder meridian (acupoint BL 67), located on the outer corner of the fifth toe, is recommended to favor cephalic version in the case of breech presentation. This point can be stimulated in various ways, including by puncture, ginger application, finger tip pressure, laser, and moxibustion. Moxibustion is the stimulation of an acupoint with the heat generated by a burning stick containing the herb Artemisia vulgaris (mugwort). This intervention may be performed for breech presentation from 28 to 35 weeks of gestation and generally is considered to be safe and without side effects.13,14 Moxibustion has been evaluated in two systematic reviews15,16 and several randomized controlled trials.17–19 and A study conducted in China showed a significant benefit from moxibustion performed daily (twice daily for some women) from 32 weeks of gestation.17 However, its effectiveness and acceptability in a non-Chinese context is controversial, and, although one trial conducted in Europe has shown effectiveness,18 another was unable to replicate these results.19 The systematic reviews conclude that more research on the effectiveness of moxibustion is needed.
Our objective was to estimate the effectiveness of moxibustion of the acupoint BL 67 between 34 and 38 weeks of gestation to promote the cephalic version of breech presentation and the acceptability of this method by women. Our hypothesis was that moxibustion will reduce the need for external cephalic version, offer an alternative to women refusing external cephalic version, and reduce the risk of cesarean delivery for breech presentation.
MATERIALS AND METHODS
We conducted a randomized controlled trial at the Department of Obstetrics and Gynecology, Geneva’s University Hospitals, Geneva, Switzerland. Women treated at our antenatal clinic or in clinics outside the hospital with a single fetus in breech presentation between 34 and 36 weeks of gestation were eligible for study inclusion. Of approximately 6,000 births per year in the county of Geneva, 4,000 deliveries take place in our hospital, but most antenatal care is provided by private practitioners. We regularly asked the private practitioners to inform their patients about the study, but only a few did it regularly.
Fetal presentation was verified by ultrasonography before randomization. Exclusion criteria were women with uterine malformation, placenta praevia, and transverse lie. Women providing consent were allocated randomly to moxibustion or expectant management. The study was approved by the institutional ethics committee, and all women gave written informed consent.
The random allocation scheme was derived from computer-generated lists of numbers with randomly permuted blocks of four, six, and eight participants. Randomization was stratified according to the intention of the women to attempt external cephalic version should the fetus still be presenting as a breech at 37 weeks of gestation. This was done to avoid a large imbalance in this important prognostic factor for breech presentation at delivery between the two groups. For each stratum, a set of sealed and consecutively numbered opaque envelopes were prepared. Consenting women were allocated randomly to one of the two groups by opening the next available envelope. This was done by a collaborator of the clinical research unit during a telephone call.
The intervention was performed by two midwives trained in acupuncture using moxa (the Japanese name for mugwort) sticks made from Artemisia vulgaris (Suzhou Shenlong Medical Apparatus Factory, Suzhou, China) that burn without smoke. The smoldering stick was placed close to the BL 67 acupoint, next to the outer corner of the fifth toenail, for a total of 20 minutes (10 minutes on each side). The woman was asked for her perception of heat to adapt the distance between the moxa stick and the skin. The technique requires a sensation of intense heat but no painful burning. The first 12 women included in the moxibustion group underwent three sessions per week in the hospital, with cardiotocographic surveillance of the fetus during the sessions to assess the effects.20 Because no cephalic version was observed in this group, we consulted with two acupuncturists and decided to increase the frequency of the intervention, asking women to perform moxibustion at home in addition to the hospital sessions. During the first session, women were trained by the midwife to perform the intervention at home on the days they did not receive it at the hospital. We also provided women with a leaflet explaining the technique to facilitate their partners’ help in performing the sessions. A maximum of 14 sessions was scheduled over 2 weeks according to generally accepted protocols.17,18 Before each hospital session, fetal presentation was verified using ultrasonography. The intervention was stopped when cephalic version was diagnosed or after 2 weeks of treatment. No specific intervention was performed in the control group. Further management was according to our local guidelines. For both groups, external cephalic version was suggested to women with a breech presentation fetus at 37 weeks of gestation. If unsuccessful or not attempted, options regarding the mode of delivery (elective cesarean delivery or an attempt at vaginal delivery) were discussed.
The main analysis was the comparison of the proportion of women with fetuses in cephalic presentation at delivery or before external cephalic version if attempted. A secondary outcome was the proportion of fetuses in cephalic presentation at delivery, including after successful external cephalic version. Other outcomes were mode of delivery, perineal injury or complications of delivery, proportion of neonates with Apgar scores less than 7 at 5 minutes and arterial cord blood pH less than 7.10, neonatal complications, and the total duration of hospital stay for both woman and neonate. We also assessed side effects (pain using a visual analogic scale and qualifiers, approximate number and quality of contractions, change in fetal movements, and other side effects reported by the women) and women’s opinions on the intervention using a questionnaire submitted after the last moxibustion session. After delivery, we contacted women in both groups to collect information on other methods eventually used to favor version, including acupuncture and moxibustion of the BL 67 acupoint in the control group.
Data were managed and analyzed with EpiInfo (Centers for Disease Control and Prevention, Atlanta, GA) and SPSS (SPSS Inc., Chicago, IL) software. All analyses were conducted on an intention-to-treat basis. Means, with their standard deviations, were calculated for continuous variables, and the statistical significance of differences between groups was tested with the Student t test. We estimated the effect of the intervention by the relative risk and its 95% confidence interval. A stratified analysis was performed to adjust for an imbalance in baseline characteristics between the groups using the Mantel-Haenszel method. Proportions were compared between groups, and differences were tested using the Fisher exact test.
We calculated that a sample size of 212 women (106 per group) had a power of 80%, with a two-tailed α of 0.05, to show a statistically significant difference in the incidence of the main outcome measure. We hypothesized a difference in cephalic presentation at delivery for not performing external cephalic version or before external cephalic version of 15% (10% in the control group and 25% in the moxibustion group).
Between October 2004 and December 2008, we recruited 212 women for the study. Of these, 106 were assigned randomly to the moxibustion group and 106 to the control group (Fig. 1). There were more nulliparous women in the moxibustion group (Table 1). Other baseline characteristics were similar between groups. A total of 80.7% of women agreed to undergo external cephalic version in the case of persisting breech presentation, which was similar between groups as a result of stratified randomization. A slightly different percentage of women in the two groups (44% in the moxibustion group and 49% in the control group) declared their intention to attempt vaginal delivery in the case of persistent breech presentation.
In the moxibustion group, the mean number of sessions was 10, with 54% of participants having 14 sessions. One woman had no sessions because of spontaneous version after randomization but before the first session, and one completed two sessions on some days for a total of 17 sessions. Compliance was good in the moxibustion group—only two women abandoned the treatment (one woman considered that attending the sessions was logistically too difficult, and the other suffered from anxiety for the wellbeing of her fetus unrelated to moxibustion).
There was a similar number of fetuses in cephalic presentation at delivery or before external cephalic version in both groups: 18% in the moxibustion group compared with 16% in the control group (relative risk 1.12, 95% confidence interval 0.62 to 2.03) (Table 2). Slightly more attempts and successful outcomes of external cephalic version were observed in the control group. Fetal presentation at delivery (including successful external cephalic version) and mode of delivery were similar between groups, with no differences in maternal and perinatal outcomes.
Acceptability and women’s perception of moxibustion were very favorable (Table 3). Most women reported no or minimal pain (96%), and mean evaluation of pain during sessions using a visual analogue scale from 0 to 100 mm was 8 mm (range 0–50). Most women (93%) reported no contractions or fewer than 10 per day during the intervention period. Fetal movements were perceived as increased by 53% of women and reported as unchanged by 43%. No women reported a disturbing side effect during the sessions, and most described the session as pleasant or relaxing.
A large percentage of women had tried other methods, apart from external cephalic version, to facilitate the version of the fetus (35% in the control group compared with 12% in the moxibustion group). In the control group, 16 women (15%) had undergone moxibustion or acupuncture of the BL 67 acupoint in private practice. Two cephalic versions were observed in this subgroup. Excluding these women (per protocol analysis) does not change the results (17% version in both groups). In both groups, postural techniques were the most frequent alternative method (22 in the control group and seven in the moxibustion group).
We were unable to show a benefit from moxibustion to facilitate the version of fetuses in breech presentation near term. Our study was initiated with the objective to replicate the very encouraging results of a trial conducted in China.17 Another study reported during the conduct of our trial also suggests that stimulation of the BL 67 acupoint for 2 weeks favors cephalic version.18 Although the mode of stimulation varies, most experts recommend moxibustion for this indication, and we used this standard technique during our trial.21 There is no consensus on the optimal frequency of the intervention, and reports ranged from twice daily to twice weekly depending on the study.14,17,18 We initially proposed three sessions per week. To maximize the potential effect of the intervention, women were asked to perform the intervention at home in addition to the hospital sessions, thus increasing the frequency to one session daily.21 This is similar to the protocol used in an earlier trial.17 Daily sessions in the hospital may be more effective, but we believed that such an intensive schedule would be very difficult to perform outside the research setting. In our study, most sessions were performed by a midwife with formal acupuncture training and others by a midwife trained to perform this intervention. Two medical doctors who specialized in acupuncture were consulted frequently and supervised the intervention. We considered that the intervention was performed too early in other trials,17–19,22 at 28 to 33 weeks of gestation, when spontaneous version is very likely without intervention.1 We chose to start the intervention only after 34 weeks of gestation.
Moxibustion was shown to be effective in a trial conducted in China. Our hypotheses were that there may be differences regarding the efficacy and the acceptability of the intervention in a Western context. Chinese women are accustomed to self-performing moxibustion for a variety of indications, and, therefore, there may be a lesser efficacy of the intervention in a context where the technique is less familiar. A placebo effect also may play a role, with improved efficacy if the intervention is culturally widely accepted and trusted. The two trials conducted in Europe had conflicting results. One study including 226 women showed 54% cephalic version with combined acupuncture and moxibustion compared with 37% in the control group.18 The study conducted by Cardini in Italy was stopped early because of the low compliance of participants and the absence of a difference in version between groups.19 In our study, compliance of women was excellent—nearly all participants attended all scheduled sessions. In contrast with Cardini, we used smokeless moxa sticks to avoid intolerance and potential toxicity from the smoke of the traditional sticks.19 A qualitative study suggests that women viewed moxibustion as a natural and noninvasive method of version to improve delivery outcomes.8 In addition, it has the advantage over acupuncture to be feasible as a treatment at home, thus reducing travel and costs. Similar to our study, women cited the therapeutic relationship with the practitioner as a positive aspect of moxibustion. The midwife verified the fetal presentation before each intervention at our hospital, which was reassuring for the women because they could avoid an unnecessary procedure.
The effect of moxibustion on fetal movements was reported differently in previous studies. Cardini reports increased movements, whereas Neri notes reduced fetal activity. In our study, approximately half of the women in the moxibustion group perceived increased movements, whereas the others reported no change.
We compared moxibustion with usual expectant management (no treatment) in this trial. Sham acupuncture, using retracting needles or false acupoints, has been advocated to evaluate the effects of acupuncture.23 Similar to others, we consider that a comparison with sham treatments is difficult to implement and may be inappropriate in specific situations.24–26 Location of the BL 67 acupoint is well described, including on the Internet, and easily identified by participants, thus making true blinding unlikely. We also believe that the clinically relevant question is whether moxibustion sessions have a positive effect, including the effect of meeting the practitioner and the eventual placebo effect, compared with usual practice.
Among women informed about the trial, those meeting with the research midwife were very keen to try moxibustion and other techniques to avoid breech presentation at the time of delivery. Some women (n=18) refused to participate after being informed that the study was a randomized trial, fearing being allocated to the control group. Despite initial consent to refrain from performing moxibustion or other techniques to favor cephalic version, one third of women in the control group tried one or more of these interventions with a private practitioner. This theoretically may reduce the measured effect of the intervention if they were effective.
There was a marked difference between the choices of mode of delivery at study inclusion in the case of persisting breech and the actual decision. Half of the women declared that they favored a trial of vaginal delivery at randomization, but fewer than one fourth actually attempted it. In addition, a smaller proportion in the moxibustion group tried external cephalic version. This may be interpreted as a general reluctance to undergo caesarean delivery but accepting it as a reality after one attempt at an alternative method, whatever the technique employed.8 It also may be evidence of the effect of the discussion with the obstetrician at the end of pregnancy, including the explanation of the results of the larger trial on breech delivery.2
Few randomized trials have been conducted to evaluate the validity of complementary medicine interventions. Despite the general acceptance and the belief that they are effective and do not cause harm, it is important to assess these interventions rigorously before wide implementation in routine practice.
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