Moxibustion for Correction of Breech Presentation (2024)

Context.—Traditional Chinese medicine uses moxibustion (burning herbs to stimulateacupuncture points) of acupoint BL 67 (Zhiyin, located beside the outer cornerof the fifth toenail), to promote version of fetuses in breech presentation.Its effect may be through increasing fetal activity. However, no randomizedcontrolled trial has evaluated the efficacy of this therapy.

Objective.—To evaluate the efficacy and safety of moxibustion on acupoint BL 67to increase fetal activity and correct breech presentation.

Design.—Randomized, controlled, open clinical trial.

Setting.—Outpatient departments of the Women's Hospital of Jiangxi Province,Nanchang, and Jiujiang Women's and Children's Hospital in the People's Republicof China.

Patients.—Primigravidas in the 33rd week of gestation with normal pregnancy andan ultrasound diagnosis of breech presentation.

Interventions.—The 130 subjects randomized to the intervention group received stimulationof acupoint BL 67 by moxa (Japanese term for Artemisia vulgaris) rolls for 7 days, with treatment foran additional 7 days if the fetus persisted in the breech presentation. The130 subjects randomized to the control group received routine care but nointerventions for breech presentation. Subjects with persistent breech presentationafter 2 weeks of treatment could undergo external cephalic version anytimebetween 35 weeks' gestation and delivery.

Main Outcome Measures.—Fetal movements counted by the mother during 1 hour each day for 1 week;number of cephalic presentations during the 35th week and at delivery.

Results.—The intervention group experienced a mean of 48.45 fetal movements vs35.35 in the control group (P<.001; 95% confidenceinterval [CI] for difference, 10.56-15.60). During the 35th week of gestation,98 (75.4%) of 130 fetuses in the intervention group were cephalic vs 62 (47.7%)of 130 fetuses in the control group (P<.001; relativerisk [RR], 1.58; 95% CI, 1.29-1.94). Despite the fact that 24 subjects inthe control group and 1 subject in the intervention group underwent externalcephalic version, 98 (75.4%) of the 130 fetuses in the intervention groupwere cephalic at birth vs 81 (62.3%) of the 130 fetuses in the control group(P=.02; RR, 1.21; 95% CI, 1.02-1.43).

Conclusion.—Among primigravidas with breech presentation during the 33rd week ofgestation, moxibustion for 1 to 2 weeks increased fetal activity during thetreatment period and cephalic presentation after the treatment period andat delivery.

IN CASES OF BREECH presentation at the onset of labor, delivery is associatedwith additional risks: for the mother, cesarean delivery and for the neonate,physical injury. Breech presentation is common in the midtrimester pregnancyand the incidence decreases as the pregnancy approaches term because of spontaneousversion.^1-4It is reasonable to assume (although not firmly established) that fetal activityplays an important role in spontaneous version.^5-9The incidence of breech presentation at delivery can be reduced, but not eliminated,by the use of external cephalic version (ECV).¹⁰

Since ancient times, traditional Chinese medicine has proposed moxibustionof acupoint BL 67 (Zhiyin) to promote version of fetuses in breech presentation.Moxibustion is a traditional Chinese method that uses the heat generated byburning herbal preparations containing Artemisia vulgaris (mugwort) (the Japanese name is moxa) tostimulate acupuncture points. Acupoint BL 67 is beside the outer corner ofthe fifth toenail.

At present, there are no randomized, controlled clinical trials to evaluatethe efficacy of this therapy. The 2 published Chinese studies^11,12are not randomized and are based on a mixed population of primipara and multiparasubjects stimulated at varying times between the 28th and 38th weeks of pregnancy.Although both studies give encouraging results and stimulate reflection regardingpossible mechanisms of action, they do not allow definitive conclusions regardingefficacy because they are not randomized, little information is provided aboutthe population sample, and the times at which stimulation is applied are wideranging.

Cardini et al¹³ identified the stageof pregnancy at which stimulation should commence and the parity status ofthe groups studied as primary factors to ensure the reliability of a clinicaltrial concerning spontaneous or induced correction of breech presentation.

Data in the literature concerning the probability of spontaneous correctionindicate that correcting breech presentation before the 32nd week is useless.^14-16 There is also a sharpdifferentiation between multigravidas (high likelihood of spontaneous correctionof breech presentation, even between the 32nd and 35th weeks) and primigravidasor multigravidas with a previous breech presentation at term (low probabilityof spontaneous version after the 32nd week).^15-17

Gottlicher and Madjaric,^15,16by ultrasound examination of 4066 pregnant women, defined the likelihood ofspontaneous correction of breech presentation from the 33rd week of pregnancyas 15.5% (95% confidence interval [CI], 2.8%-28.2%) for primigravidas and57.5% (95% CI, 36.3%-78.7%) for multigravidas.

Westgren et al,¹⁷ by ultrasound screeningof 4600 women in the 32nd week of pregnancy, identified 310 cases (6.7%) ofbreech presentation, which were prospectively studied until birth. Rates ofspontaneous cephalic version varied, according to whether subjects were primigravida(46%), multigravida with a previous breech presentation (32%), or multigravidawith no previous breech presentation (78%). All the studies available reportdata relating to Western populations and we have been unable to retrieve anyinformation regarding the spontaneous version rate from the 33rd week to termamong Chinese pregnant women.

Given this background, Cardini and Marcolongo,¹⁸in a retrospectively controlled clinical trial, compared 23 primigravidastreated for breech presentation by moxibustion in the 32nd and 33rd week witha retrospective, untreated group at the same stage of pregnancy. The differencein prevalence of breech presentation showed borderline statistical significance(P=.05). Thus, the subgroup of primigravidas withbreech presentation at the 33rd week of pregnancy seemed to be the ideal populationfor a randomized, controlled clinical trial.

We undertook this study to evaluate the efficacy and safety of moxibustionon acupoint BL 67 in correcting breech presentation in a population of primigravidastreated since the 33rd week of pregnancy and to evaluate the efficacy of thistechnique in increasing active fetal movements (AFMs).

These 2 main objectives are consistent with the hypothesis that theuse of moxibustion in women whose fetuses are breech in the 33rd week of pregnancywill (1) increase fetal activity; (2) reduce the proportion of fetuses thatremain in a nonvertex presentation and, hence, decrease the need for ECV;and (3) decrease the incidence of breech presentation at birth. A secondaryaim of the study was to assess the efficacy of 2 different dosages of moxibustion.

This was a randomized, controlled, open clinical trial of subjects treatedby moxibustion since the 33rd week of pregnancy (intervention group) vs untreatedsubjects (control group). Subjects with persistent breech presentation after2 weeks' treatment (intervention group) or observation (control group) couldundergo ECV. Moxibustion in the early third trimester and ECV in late pregnancyare the standard care for breech presentation in both the centers involvedin the trial. Thus (and also for ethical reasons), the availability of ECVwas maintained for all subjects recruited.

Subjects were included if they were primigravidas, in the 33rd weekof gestation (from 32 weeks + 1 day to 33 complete weeks, based on the lastmenstruation date and ultrasound data), with breech presentation diagnosedby ultrasound within 24 hours of randomization, and with normal fetal biometry(biparietal diameter and abdominal circumference between the 10th and 90thpercentiles). Subjects were excluded if they had pelvic defects, previousuterine surgery, uterine malformation or fibromyoma of diameter greater than4 cm, fetal malformation, twin gestation, tocolytic therapy during pregnancy,risk of premature birth (uterine hypercontractility and/or initial shorteningor dilatation of the neck, with a Bishop score ≥4), or pathological pregnancy(eg, intrauterine growth retardation, gestosis, serious infections, placentaprevia, polyhydramnios, oligohydramnios) judged by the investigator to contraindicateinclusion in the study. Subjects refusing to undergo treatment were also excluded.

The trial was conducted from April 1995 through August 1996 in the Women'sHospital of Jiangxi Province, Nanchang, People's Republic of China. A fewsubjects (23) were recruited in the nearby Jiujiang Women's and Children'sHospital, also in Jiangxi Province. The subjects were recruited during theroutine management of normal pregnancies in the outpatient department. Allprocedures were executed by midwives (with the supervision of physicians)except ultrasound examinations and ECVs. The protocol followed the ethicalstandards of the Declaration of Helsinki.

Pregnant women fulfilling all criteria of the study were asked to participate.Interested subjects gave oral informed consent. Subjects had an ultrasoundscan at the 33rd week. On the day of the ultrasound scan by which breech presentationwas confirmed, the selected subject was randomly assigned to 1 of the 2 groups.The sample was randomly allocated by numbered envelopes (randomized in groupsof 10 by the computer program PACT, Version 2.0 [Glaxo-Wellcome, London, England],in Italy). Once randomized, subjects and investigators were aware of groupassignment. All subjects recruited were advised to avoid or, at least, toask the investigators about other interventions or therapies that could contaminatethe results of the trial.

All subjects were asked to return after 2 weeks for an ultrasound checkon presentation. If breech presentation persisted at this time, the subject(after giving informed consent) could undergo ECV in the following weeks.

All subjects were also asked to complete 2 record forms for AFMs, 1for each of the 2 weeks subsequent to recruitment. These 2 forms were returnedat the time of the ultrasound examination. Each record form had to be completedonce daily for 7 days, reporting the number of AFMs counted in 1 hour (ifpossible, between 5 and 8 PM) and times of starting and finishing the count.

Finally, each subject was asked to report all significant details ofher pregnancy and delivery during a personal or telephone appointment aftershe had given birth. The following specific information was collected: dateof birth, place of birth, name and address of the obstetrician normally consulted,and name and address of the obstetrician present at birth. In this way, itwas possible to consult other sources of information (obstetrician normallyconsulted, obstetrician present at birth, patient record forms) if the subjectprovided incomplete or unreliable information. Because almost all the enrolledsubjects gave birth in the same hospital where they had been studied, informationabout delivery was reliable and easy to check.

If the subject belonged to the intervention group, she was admittedto the hospital to attend an instruction session within 24 hours of randomization,alone or with her partner or the person who was actually going to help administerthe treatment. Teaching the technique for applying moxibustion at home includedpresenting the moxibustion material (cigar-shaped rolls containing Artemisia), locating of acupoint BL 67, and explaining the techniquefor stimulation of acupoint BL 67. During the therapy the subject relaxedin the sitting or semisupine position, with the partner sitting comfortably.The therapy was executed for 30 minutes (15 minutes per side) daily for 7days in the first 87 subjects, and twice daily in the last 43 subjects. Thesubjects were allowed to choose the time, ensuring no interruptions in thetherapy (if possible, between 5 and 8 PM). The intensity of moxibustion wasjust below the individual tolerability threshold, causing hyperemia from localvasodilatation but not burn blisters.

Reasons for discontinuing stimulation and consulting the investigator(abdominal pain, other suspected adverse effects, sensation that version hadoccurred before completion of 7 days' treatment) were explained to the subject,together with symptoms suggesting that version had occurred (decreased pressurein the epigastrium or hypochondrium, increased pressure in the hypogastrium,pollakiuria, a "different feeling" in the abdomen). The first stimulationsession was executed in the hospital and the necessary materials for the following6 days' stimulation were dispensed, together with the AFM record forms.

Last, an examination after 1 week's treatment (visit 2) was scheduled.Visit 2 included a check on presentation and collection of the AFM recordform. The presentation check was by localization of fetal heartbeats and abdominalpalpation (Leopold maneuvers). Ultrasound examination was performed only inthe event that the techniques described herein failed or yielded uncertainfindings.¹⁹ This was to avoid an excess ofultrasound examinations, given that an ultrasound examination was scheduledfor the 35th week in all subjects. If cephalic version had not occurred, anotherweek's treatment was advised if there were no adverse effects and the subjectagreed to continue. Further moxa rolls were thereforedispensed to the subject with a second AFM record form. The frequency of thetreatment was the same as in the first week. Visit 3 was scheduled and executedafter a further week; the procedure was the same for all treated and untreatedsubjects as described herein (Figure 1).

The primary outcomes were number of cephalic presentations at the 35thweek and at birth and fetal motor activity. Secondary outcomes were compliancewith treatment, observation of possible adverse effects in the interventiongroup and adverse events in both groups, number of cephalic versions after1 and 2 weeks of treatment (ie, 34th and 35th weeks' gestation), number ofcephalic versions with 2 different dosages of moxibustion (once or twice daily),number and causes of cesarean deliveries, spontaneous and induced vaginaldeliveries, and Apgar score at 5 minutes.

On the basis of the study by Cardini and Marcolongo,¹⁸for primigravidas it seemed possible to identify a 30% difference in the numberof cephalic presentations at the 35th week and at term between the interventionand control groups, with an α significance level of .05 and greaterthan 90% power if 60 subjects per group completed the study. Given that thereliability of the preliminary study was limited because it was based on retrospectivedata and that we decided to assess the efficacy of 2 different dosages ofmoxibustion, the number of enrolled subjects was increased to 130 per group.

Even if not attributable to 1 of the causes specified in the researchprotocol, discontinuation of treatment did not entail the subject's exclusionfrom the study. Outcomes of all subjects recruited were analyzed on the basisof intention to treat. Every possible effort was made to ascertain the reasonfor withdrawal.

The statistical processing was performed using Epi Info, Version 6.04(Centers for Disease Control and Prevention, Atlanta, Ga). The χ² test (supplemented, where necessary, by the Fisher exact test) andthe t test were used for comparing qualitative andcontinuous variables, respectively. The measurement of effects was also describedin terms of relative risk (RR) with 95% confidence intervals (CIs).

The total number of subjects was 260 (130 subjects per group), recruited,randomized, observed, or treated and followed up to delivery. No significantdifferences emerged between the intervention group and the control group(Table 1). Neither the placentallocalization and grading nor the amount of amniotic fluid at the 33rd weekshowed significant differences between the 2 groups.

The main results of the trial are summarized in Table 2. At the ultrasound check at the 35th week of gestation(2 weeks after the first visit), 98 (75.4%) of 130 fetuses in the interventiongroup were cephalic compared with 62 (47.7%) of 130 in the control group(P<.001; RR, 1.58; 95% CI, 1.29-1.94).

After 35 weeks of pregnancy, only 1 subject in the intervention groupagreed to undergo ECV, but version was not obtained. Twenty-four subjectsin the control group agreed to undergo ECV and in 19 subjects cephalic versionwas obtained. Despite this, the number of cephalic presentations at birthwas still significantly different in the 2 groups: 98 (75.4%) of 130 in theintervention group compared with 81 (62.3%) of 130 in the control group (P=.02; RR, 1.21; 95% CI, 1.02-1.43). The results obtainedexcluding subjects treated with ECV are shown in Table 2.

Of the 98 cephalic versions obtained in the intervention group, 82 occurredduring the first week and 16 during the second week of treatment. The cephalicor breech presentations observed at the second visit (35th week of pregnancy)remained unchanged up to term in all subjects treated and observed, exceptfor those successfully treated with ECV.

The only intervention allowed for the subjects in the control groupwas ECV during the last 5 weeks of pregnancy. They were specifically questionedat the 35th week and after delivery and none reported having been treatedwith moxibustion or other therapies.

Among the intervention group only 1 subject failed to comply with thetreatment schedule prescribed and discontinued the therapy. At the end ofthe first week of treatment 8 subjects withdrew from therapy, 3 on the adviceof the obstetrician (for Braxton Hicks contractions, breech engagement, andmaternal tachycardia and atrial sinus arrhythmia, respectively) and 5 subjectsfor unspecified reasons. All 9 subjects maintained the breech presentationsof their fetuses to term and none of them were excluded from the statisticalanalysis.

The form of discomfort most frequently reported by both groups was asense of tenderness and pressure in the epigastric region or in one of thehypochondria (epigastric crushing) attributable to the head of the breechfetus pressing against the maternal organs.

No adverse events occurred in the intervention group during treatment.After treatment, 2 premature births occurred (both at 37 weeks), 1 of whichwas preceded by premature rupture of the membranes (PROM). There were 4 PROMsin the intervention group.

Adverse events occurring in the control group included 3 premature birthsat 34, 35, and 37 weeks (the third was preceded by placental detachment withfetal distress) and 1 intrauterine fetal death (intrauterine growth retardationand oligohydramnios, spontaneous delivery at 38 weeks; growth was within normallimits at ultrasound examination at 35 weeks). The total number of PROMs inthe control group was 12.

Regarding the efficacy of the moxibustion treatment in producing anincrease in fetal motility, comparison between the 2 groups proved possiblefor only the first week of treatment (or observation) because all the subjectsin the intervention group who achieved cephalic version in the first weekof treatment filled in only the first of the 2 record forms used for the weeklyAFM counts. The mean value for fetal movements recorded during a 1-hour observationperiod for 7 days was 48.45 for the subjects in the intervention group and35.35 for the subjects in the control group (difference, 13.08; 95% CI, 10.56-15.60; t test, 10.215; P<.001).

In the intervention group, the first 87 subjects received 1 stimulationper day, lasting 30 minutes, for 7 or 14 days (QD [quaquedie] group). The last 47 subjects received 2 30-minute stimulationsper day for 7 or 14 days (BID [bis in die] group).The 2 subgroups showed no significant differences in amount of amniotic fluidduring the 33rd week, frequency of straight or bent leg position during the33rd week, placental localization, neonatal sex, treatment compliance, oradverse effects attributable to the treatment.

At the end of the first week of treatment in the BID group, 34 (79.1%)of 43 cephalic versions were obtained compared with 48 (55.2%) of 87 in theQD group (P=.007; RR, 1.43; 95% CI, 1.12-1.83).

During the second week of treatment, 15 additional cephalic versionswere obtained in the QD group and only 1 additional version in the BID group.Thus, the following cephalic presentation results were observed on ultrasoundexamination at the end of the second week of treatment: 63 (72.4%) of 87 inthe QD group and 35 (81.4%) of 43 in the BID group (nonsignificant difference).The same percentages were maintained to term.

No statistically significant differences were found in the number ofcesarean deliveries performed. In the intervention group, 46 cesarean deliveries(35.4% of births) were performed, 20 of which were with cephalic presentationsand 26 of which were with breech presentations. The 20 cesarean deliveriesin the cephalic presentations were performed for fetopelvic disproportion(14 cases), postterm pregnancy (3 cases), or fetal distress (3 cases). The26 cesarean deliveries in the breech presentations were performed for PROMafter week 37 (10 cases), large fetus (2 cases), fetal distress (1 case),oligohydramnios (2 cases), and unspecified causes (11 cases).

In the control group, 47 cesarean deliveries (36.2%) were performed,21 of which were with cephalic presentations and 26 of which were with breechpresentations. Indications for cesarean delivery in the subjects with cephalicfetuses included fetopelvic disproportion (11 cases, 1 of which was with oligohydramnios),fetal distress (4 cases, 1 of which was in a subject with toxemia of pregnancy),sacral rotation of the occiput (2 cases), placental insufficiency (1 case),toxemia of pregnancy (1 case), PROM (1 case), and deep transverse arrest (1case). Cesarean deliveries in the breech presentations were performed forPROM after 37 weeks (8 cases, 1 of which was with prolapse of the cord), oligohydramnios(3 cases), fetal distress (2 cases), large fetus (1 case), and unspecifiedcauses (12 cases).

In both the intervention and control groups, cesarean delivery revealed1 case of previously undiagnosed bicornuate uterus. In both cases, the presentationat birth was breech. Because they had been randomized, both cases were includedin the statistical analysis of the data despite uterine malformations beingexclusion criterion.

In regard to vaginal deliveries, the only significant difference betweenthe 2 groups relates to the use of oxytocin, given to 7 (8.6%) of 81 subjectsin the intervention group vs 25 (31.3%) of 80 in the control group (RR, 1.33[95% CI, 1.13-1.56]; P <.001) before or duringlabor. In the intervention group, 2 vacuum-extractor and 1 forceps deliverieswere performed and in the control group, 2 vacuum-extractor and 3 forcepsdeliveries were performed.

No neonates in the intervention group, but 7 in the control group, hadApgar scores of less than 7 at 5 minutes (Fisher exact test, P =.006). On grouping Apgar scores in the traditional manner, in theintervention group no neonates had Apgar scores less than 4 and 4 had scores4 to 7; in the control group, 2 neonates had Apgar scores less than 4 and12 had scores 4 to 7.

Moxibustion is a popular and much appreciated therapy for breech presentationin the People's Republic of China; thus, it would have been impossible topropose a "sham moxibustion" as a placebo for the control group.

Furthermore, moxibustion is a typical cheap, self-administered hometherapy. This made blinding practically impossible. It was very difficultfor investigators to persuade subjects to accept randomization and the consequentrisk of having to do without the therapy. Consent was often obtained becauseof the availability of ECV later in pregnancy, but this is a much less popularand somewhat feared therapy; thus, only a few subjects, mostly belonging tothe control group, opted for this solution.

Because the main results of the trial are of a qualitative type andwere measured objectively (ultrasound), we believe that the lack of blindingand a placebo does not undermine the validity of the results. This is notentirely the case when considering fetal movement count, which was subjectivelyassessed.

The choice of sample (primigravidas at the 33rd week of gestation) appearsto have been appropriate because the presentation did not change after the35th week in any of the subjects (except for those undergoing ECV). This confirmsthe rarity of spontaneous fetal version (to either breech or cephalic presentation)among primigravidas after the 35th week.¹⁶

Two half-hour stimulations per day proved more effective in producingcephalic version than a single stimulation. On prolonging the therapy by 1week in those cases in which cephalic version was not achieved, this differencein efficacy was partly, although not entirely, annulled. Of the 2 dosages,then, twice-daily stimulation is recommended because it did not reduce treatmentcompliance and had no adverse effects. Compliance with the treatment was byand large good.

In 2 cases, disorders serious enough to prompt discontinuation wereobserved during treatment. It was not clear whether these were adverse effectsof the treatment.

No severe adverse events attributable to the treatment were observedand, in particular, there were no cases of intrauterine death or placentaldetachment. No cases of severe fetal anemia attributable to fetomaternal transfusion²⁰ were reported. The number of PROMs was similar inboth groups and the number of premature births was lower in the interventiongroup.

Moxibustion treatment did not reduce the rate of cesarean deliveriesin a population in which elective cesarean delivery is not envisaged for breechpresentations. On the other hand, it is possible that the significantly highernumber of breech presentations at birth in the control group may have beena factor in bringing about worse Apgar scores.

The mechanism of action of moxibustion appears to be through increasedAFMs, which proved significantly stronger in the treated subjects. Althougha number of studies in China^11,12,21have investigated the neurologic path of stimulation by moxibustion and haveshown evidence of its effect on maternal plasma cortisol and prostaglandins,we think that the mechanism of action of moxibustion is not entirely clearand warrants further research.

Further studies²² are needed to establishthe efficacy and safety of moxibustion at more advanced gestational ages thanthose considered in this trial, as well as in second pregnancies or multigravidasand populations other than Chinese. Moreover, it is not clear whether moxibustionis more or less efficacious than ECV at term for obtaining cephalic presentationgiven the small number of subjects (nearly all belonging to the control group)who underwent ECV. Furthermore, since moxibustion and ECV must be performedat different gestational ages, we may regard them as complementary therapiesto be used in succession. As we see it, if the results of this trial are confirmed,moxibustion should be extensively used on account of its noninvasiveness,low cost, and ease of execution. In fact, it is easy to train expectant mothers(either alone or with their partners) to administer the therapy at home. Furtherstudies are also necessary to establish whether moxibustion treatment canreduce the rate of cesarean deliveries where these are used electively forbreech presentation at birth.

Additional results regarding the effects of family history, fetal sex,cranial circumference, and leg position on the likelihood of cephalic versionwill be presented in a subsequent article.

On the basis of the results of the trial, moxibustion, when performedin primigravidas for 1 or 2 weeks starting in the 33rd week of pregnancy,has proved to be an effective therapy for inducing a significant increasein cephalic versions within 2 weeks of the start of therapy and in cephalicpresentations at birth.