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

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

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

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.

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.

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.

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.

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