Randomised Controlled Trial of the Efficacy of Acupuncture Versus Placebo on the Caesarean Section Rate in Case of Cervical Dystocia in Full-term Pregnancy

Study Overview
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Brief Summary
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The principal objective of the trial is to demonstrate that acupuncture could reduce the caesarean section rate for cervical dystocia. Secondary objectives: To demonstrate that acupuncture can: reduce morbidity, fetal mortality and duration of childbirth; reduce the cost of care, due to diminution of caesarean sections and duration of obstetric labor; to evaluate the tolerance.

Detailed Description
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In this trial, pregnant women with at least 37 weeks of amenorrhea will be randomized to traditional chinese acupuncture, sham acupuncture, or usual care only. 9 investigator sites will participate to this trial targeting to enrol 2220 patients in total. 1780 subjects will receive acupuncture treatment, either effective treatment or sham, whereas 400 patients will receive usual care only. Acupuncture therapy consists in stimulations on specific skin points of the abdominal area, which are specific acupuncture points in traditional chinese medicine for the induction of obstetric labor, according to the professional recommendations of the French Acupuncture and Traditional Chinese Medicine College. Each patient will have a 5-week follow-up in this trial.

Official Title
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A Randomised Controlled Multicenter Trial Evaluating the Efficacy of Acupuncture Versus Placebo on the Caesarean Section Rate in Case of Cervical Dystocia in Full-term Pregnancy

Conditions
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Cervical Dystocia

Intervention / Treatment
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* Device: Acupuncture
* Device: Sham acupuncture


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged ≥ 18 years Signed informed consent Woman carrying one foetus only at 37 weeks (+/- 2 days) of amenorrhea Without contraindication to vaginal delivery Exclusion Criteria: Prior history of caesarean section Non-cephalic presentation Fetal macrosomia Multiple pregnancy Chronic fetal hypoxia Placenta praevia Risk of neonatal contamination

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: acupuncture<br>The first session of acupuncture treatment will be performed at the inclusion visit, 2 additional acupuncture sessions will be scheduled as 1 session per week for the next 2 weeks. One or more additional session will be performed in the delivery room. | Device: Acupuncture<br>* Method of acupuncture: check the condition of skin, disinfect if needed, insert sterile needles with special handling for each point, remove the needles after 15 minutes.<br>|
| Sham Comparator: Sham acupuncture<br>The same as active arm but with sham needles. | Device: Sham acupuncture<br>* Sham acupuncture with sham needles<br>|
| No Intervention: control group<br>Standard care, no acupuncture session. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Caesarean section rate | Rate of caesarean section for cervical dystocia in full-time pregnancies | up to 37 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acupuncture, cervical dystocia, caesarean section, obstetric labor, randomized controlled trial