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)

Assistance Publique - Hôpitaux de Paris

Status: Terminated

Conditions: Cervical Dystocia

Treatments: Device: Acupuncture; Device: Sham acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT02394041

AOM09091 (Other Grant/Funding Number)

P081233

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 142 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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142 participants in 3 patient groups

acupuncture

Experimental group

Description:

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.

Treatment:

Device: Acupuncture

Sham acupuncture

Sham Comparator group

Description:

The same as active arm but with sham needles.

Treatment:

Device: Sham acupuncture

control group

No Intervention group

Description:

Standard care, no acupuncture session.