Archives of Gynecology and Obstetrics

, Volume 287, Issue 5, pp 887–891 | Cite as

Effects of acupuncture for initiation of labor: a double-blind randomized sham-controlled trial

Maternal-Fetal Medicine

Abstract

Purpose

This double-blind randomized controlled trial was conducted to evaluate whether use of acupuncture could initiate labor at term and thus reduce post-term induction.

Methods

Between 2010 and 2011, a total of 80 women at 38 weeks of gestation or greater were randomized to acupuncture and sham acupuncture groups. Acupuncture points LI4, SP6 and BL67 were needled bilaterally. The primary outcome was initiation of labor. The time from acupuncture to delivery, mode of delivery, fetal and maternal outcome and Apgar scores were recorded. The trial is registered at irct.ir, number IRCT201111218151N1.

Results

Eighty women were randomized and 75 women completed the study procedure. Age, BMI, parity and gestational age were similar in both groups. Spontaneous labor was initiated in 94.7 % of acupuncture group and 89.2 % of sham acupuncture group (p = 0.430). There were no statistically significant difference between groups for time from enrollment to delivery (p = 0.06).

Conclusion

According to this study, it seems that acupuncture was not effective in labor initiation compared to sham acupuncture.

Keywords

Acupuncture Randomized controlled trial Post-term pregnancy Sham acupuncture 

Abbreviation

RCT

Randomized controlled trail

BMI

Body mass index

LI4

Large intestine 4

SP6

Spleen 6

BL67

Bladder 67

GA

Gestational age

NVD

Normal vaginal delivery

ACOG

American College of Obstetricians and Gynecologists

Introduction

The timely onset of labor and delivery is an important determinant of perinatal outcome. Prevention of prolonged pregnancies continues to be a major challenge in obstetric practice. Prolonged pregnancies that extended beyond the 41 weeks of gestation are known to be at greater risk for maternal and neonatal morbidity and mortality by increasing complications such as chronic intrauterine growth restriction due to uteroplacental insufficiency, oligohydramnios, intrauterine infection, shoulder dystocia, severe perineal injury, gestational hypertension, meconium aspiration, unexplained anoxia, fetal distress, perinatal death and cesarean delivery [1, 2, 3]. Clinical guidelines recommend close fetal monitoring and awaiting cervical favorability from weeks 41 to 42 with labor induction planned based on these factors. Fetal monitoring tests are costly. Also, induction of labor is associated with higher rates of cesarean delivery, which confers increased risk for complications such as endometritis, post-partum hemorrhage and thromboembolic disease. In addition, the cost of delivery after induction of labor is higher than for spontaneous onset of labor [4, 5, 6, 7].

Many pregnant women wish to take fewer chemical drugs during pregnancy and labor, and this choice is often supported by obstetricians. Acupuncture has long been used in China and other Asian countries. In recent years, the use of alternative and complementary medicine has become popular in many western countries. The use of acupuncture is on the increase in pregnancy-related condition including breech presentation, labor pain and hyperemesis gravidarum despite limited scientific evidence of its effectiveness. It is well established that acupuncture is a safe procedure and has no known teratogenic effects. Acupuncture involves the insertion of very fine, disposable stainless steel needles into specific points of the body [8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18].

It is hypothesized that acupuncture neuronal stimulation may increase uterine contractility either by central oxytocin release or by parasympathetic stimulation of the uterus [19, 20, 21, 22].

Acupuncture’s efficacy in labor initiation has not been fully elucidated. The aim of the present study was, therefore, to evaluate the effectiveness and the safety of acupuncture in comparison to sham to initiate labor in term pregnancies.

Materials and methods

This study was approved by ethical committee of Shahid Beheshti University of Medical Sciences, Iran, and conducted between 2010 and 2011. The trial is registered at Iranian Registry of Clinical Trials, number IRCT201111218151N1.

One hundred five healthy parturients with gestational age between 38 and 42 weeks were assessed for eligibility to enter the study. All participants received written and oral information about the study and those who agreed gave written consent. Gestational ages were estimated by last menstrual period or ultrasonographic parameters before 20 weeks. Eighty women were randomized and 75 women completed the study procedure (Fig. 1).
Fig. 1

Flow diagram

The inclusion criteria were cephalic presentation, cervical dilatation less than 3 cm, intact membrane and no signs of labor. The exclusion criteria were previous cesarean section or incision of the uterus, multiple pregnancy, malformation of pelvis, skin infections, anticoagulant drug use, psychological disorders, previous inability to tolerate acupuncture, intrauterine growth restriction, suspected macrosomia, indications of emergency termination of pregnancy by induction or cesarean section before onset of labor as described by the American College of Obstetricians and Gynecologists (ACOG), and request of elective termination of pregnancy before 42 weeks of gestation.

This was a double-blind sham-controlled, parallel-group study (with balanced randomization 1:1) conducted in the obstetrical and physical medicine departments of Tajrish Hospital in Tehran, Iran. Participants were randomly allocated by parity to one of two groups according to the procedure: acupuncture or sham acupuncture. Study group assignment was determined according to computer-generated random numbers concealed in sealed envelopes. Patients, outcome assessor and statistician were blinded as to randomization. All the patients were evaluated for outcomes by one gynecologist. Sample size was determined after consideration of type 1 statistical error <5 % and power of study 80 % with 38 partureints in each group.

Routine prenatal care was given for all participants. Acupuncture treatment was performed by a licensed acupuncturist trained in traditional Chinese medicine by insertion of six sterile disposable stainless steel needles (0.25 × 25 mm). True acupuncture points included which are located on the Spleen 6 (on the inner ankle), Large intestine 4 (in the webbing between thumb and forefinger) and Bladder 67 (on the outer edge of the little toe), and needles were advanced or manipulated until ‘deqi’ was stimulated. Sham acupuncture points included non-acupuncture points in the hands and legs, and insertion was shallow. Needles were inserted at all points bilaterally and retained for 30 min for both groups. Manual stimulation provided during the time. The procedure was administered up to maximum 2 times over 1 week period (every 3 days) and routine prenatal care has been continued. Participants admitted to obstetrical ward when they had rhythmic forceful contraction (3 contractions in 10 min interval) with cervical dilatation 4–5 cm or rupture membranes. Stimulation of labor with oxytocin was used if it was necessary as described by ACOG. If the pregnancy extended beyond the 41 weeks of gestation, fetal monitoring was used as our protocol (Biophysical sonographic study every 3 days). When the fetus was compromised, induction of labor was mandatory. Pregnancies that reached 42 weeks of gestation were terminated by induction with the same route as our protocol followed in Tajrish hospital. The participants, obstetricians and outcome assessor were masked to the treatment arm. It was not feasible to blind the acupuncturist.

The primary outcome was initiation of labor defined as active labor (3 contractions in 10-min interval with cervical dilatation 4–5 cm) or rupture membranes. The time from entry (first acupuncture treatment) to delivery, mode of delivery, fetal and maternal outcome and Apgar scores at 1 and 5 min were recorded.

Results were given as mean plus or minus SD. Statistical analysis was performed using the SPSS 16.0 statistical software package (SPSS Inc., Chicago, IL, USA). Time intervals were analyzed with Mann–Whitney U test and other data were analyzed with the Chi square for qualitative and t test for quantitative variables. A p value of 0.05 was considered significant.

Results

Eighty consenting participants who fulfilled the entry criteria were enrolled in this study. Seventy-five participants were able to complete the study and their data were included in the final analyses. Two subjects in the acupuncture group and three subjects in the sham acupuncture group refused to receive any treatment for elective termination of pregnancy before 42 weeks of gestation.

Table 1 provides a summary of the baseline characteristics of both groups. There were no significant difference between two groups in terms of age, parity, gestational age, BMI and Bishop’s score before entry into the study. Thirteen participants of acupuncture group and twelve participants of sham acupuncture group were multipara (26.3 % of parturients in acupuncture group were para 1, 5.3 % were para 2 and 23.2 % of parturients in sham acupuncture group were para 1, 6.5 % were para 2). There was no any grand multipara in two groups.
Table 1

Demographic and clinical variables

 

Acupuncture (n = 38)

Sham (n = 37)

p value

Mean maternal age (years ± SD)

25.79 ± 4.99

25.3 ± 3.08

0.610*

Mean BMI (kg/m2 ± SD)

26.2 ± 1.79

26 ± 1.98

0.645*

Mean GA (days ± SD)

282.76 ± 4.99

274.65 ± 5.01

0.740*

Nulliparous, no. (%)

25 (65.8)

25 (67.6)

1*

Mean Bishop score ± SD

3.6 ± 0.8

3.4 ± 0.9

0.67*

BMI body mass index, SD standard deviation, GA gestational age

* No statistically significant difference was observed between two groups

Labor characteristics and delivery outcome data are summarized in Table 2. The mean number of acupuncture treatment was less than sham acupuncture treatment (1.5 ± 0.5 compare 1.6 ± 0.4, p value = 0.02). Spontaneous labor occurred in 94.7 % of acupuncture group and 89.2 % of sham acupuncture group, there was no significant difference between them (p value = 0.43). Two cases in the acupuncture group and four subjects in the sham acupuncture group reached 42 weeks of gestation and their pregnancies were terminated by induction. Time to delivery from enrollment tended to be shorter for the acupuncture group (7.76 ± 6.84 days) compared to the sham acupuncture group (9.46 ± 5.97 days). However, this difference was not statistically significant (p value = 0.06).
Table 2

Maternal and fetal outcomes

 

Acupuncture (n = 38)

Sham (n = 37)

p value

Maternal outcomes

 Spontaneous labor, no. (%)

36 (94.7)

33 (89.2)

0.430*

 Interval from procedure to delivery (days ± SD)

7.76 ± 6.84

9.46 ± 5.97

0.066*

 NVD, no. (%)

35 (92.1)

30 (81.1)

0.191*

 Cesarean, no. (%)

3 (7.9)

7 (18.9)

0.191*

 Stimulation of labor, no. (%)

10 (27.8)

12 (36.4)

0.613*

 Mean number of procedure ± SD

1.5 ± 0.5

1.6 ± 0.4

0.02

Fetal outcomes

 Fetal distress, no. (%)

1 (2.63)

2 (5.40)

0.313*

 Mean Apgar score ± SD (1 min)

8.9 ± 0.6

8.70 ± 0.4

0.76*

 Mean Apgar score ± SD (5 min)

9.4 ± 0.3

9.5 ± 0.4

0.82*

 NICU admission, no.

0

0

1*

NVD normal vaginal delivery, SD standard deviation, NICU neonatal intensive care unit

* No statistically significant difference was observed between two groups

There was no significant difference among two groups for mode of delivery, 92.1 % of participants in acupuncture group and 81.1 % of participants in sham acupuncture group were delivered vaginally. Cesarean section was used for 3 cases of acupuncture group (1 case fetal distress, 2 cases unresponse to induction) and 7 cases of sham acupuncture group (2 cases fetal distress, 5 cases unresponse to induction). There were no significant differences between two groups for maternal and fetal complications, 1 and 5 min Apgar scores.

Discussion

Prolongation of pregnancy complicated up to 10 % of all pregnancies and carries increased risk to both mother and fetus. The majority of post-term pregnancies have no known cause. The factors that affect are uncertain dating, fetal abnormality (e.g., anencephaly), nulliparity, prior post-term pregnancy and high maternal body mass index [23, 24, 25].

Recently, the use of complementary medicine has become popular in many countries. Acupuncture originated in China approximately 2,000 years ago. Acupuncture also refers to a family of procedures used to stimulate anatomical points. Aside from needles, acupuncturists can incorporate manual pressure, electrical stimulation, magnets, low-power lasers, heat and ultrasound. Despite this diversity, the techniques most frequently used and studied are manual manipulation and electrical stimulation of thin, metallic needles inserted into skin. There are conflicting evidences that acupuncture can reduce the need for induction of labor for post-term pregnancies. The studies suggested that stimulation of some points could be initiated of labor pain, for example, stimulation of BL67 point could be used to stimulate uterine contractions, LI4 point could be used to help the woman push downwards and to stimulate uterine contractions and SP6 point to promote ripening of the cervix [8, 10, 13].

Rabl [26] undertook a single-blind randomized controlled trial involving 45 parturients. The trial compared acupuncture to standard care. The aim of this study was to evaluate whether acupuncture at term can influence cervical ripening, induce labor and thus reduce the need for postdate induction. Acupuncture at points LI4 and SP6 supports cervical ripening at term. The cervical length in the acupuncture group was shorter than that in the control group.

These findings are in contrast to Asher [3] that undertook a trial to evaluate the efficacy of acupuncture for labor stimulation. Eighty-nine parturients at 38 weeks or greater were randomized to acupuncture, sham acupuncture or usual care groups. Acupuncture involved the insertion of needles into bilateral points: LI4, SP6, BL32 and BL54. There were no statistically significant differences among groups for time from enrollment to delivery, rates of spontaneous labor or rates of cesarean delivery.

The results of our study revealed no effect of acupuncture on initiation of labor in term pregnancies. The mean number of procedure in acupuncture group was less than sham acupuncture group. Lower the number of procedure in acupuncture group could be due to a shorter time from entry to delivery in acupuncture group. Probably, with a larger sample size study more complete results can be obtained.

There are a few previous studies that evaluated the effects of acupuncture on initiation of labor at term pregnancy. There are some points in our trial that make the study different from the prior studies such as investigation of two groups instead of three groups; use of sham acupuncture for masking participants, researchers, obstetrical ward staff and trial statistician; performing of the procedure by only one acupuncturist to decrease technical errors; and no difference of known risk factors of post-term pregnancy such as BMI between two groups.

On the other hand, there are some limitation factors including small sample size, some unknown causes of post-term pregnancy that we could not match them in two groups. In addition, fear of needle in acupuncture procedure and fear of fetal complications by parturients and their families was restricted factors in our trial.

Conclusion

According to this RCT study, it seems that acupuncture treatment was not effective in initiating of labor compared to sham acupuncture.

Notes

Conflict of interest

None.

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Copyright information

© Springer-Verlag Berlin Heidelberg 2012

Authors and Affiliations

  1. 1.Department of Obstetrics and Gynecology, Tajrish HospitalShahid Beheshti University of Medical SciencesTehranIran
  2. 2.Department of Physical Medicine and Rehabilitation, Tajrish HospitalShahid Beheshti University of Medical SciencesTehranIran

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