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

NCT ID: NCT02394041

Last Updated: 2015-03-20

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 142 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-11-30
• Study Completion Date: 2014-07-31

Brief Summary

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

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.

Conditions

Cervical Dystocia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

acupuncture

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.

Group Type: EXPERIMENTAL

Acupuncture

Intervention Type: DEVICE

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.

Sham acupuncture

The same as active arm but with sham needles.

Group Type: SHAM_COMPARATOR

Sham acupuncture

Intervention Type: DEVICE

Sham acupuncture with sham needles

control group

Standard care, no acupuncture session.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Acupuncture

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.

Intervention Type: DEVICE

Sham acupuncture

Sham acupuncture with sham needles

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Denis COLIN, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Obstetrics, Hôpital Saint-Cloud

Locations

Department of Obstetrics, Hôpital Saint-Cloud

Saint-Cloud, Hauts-de-Seine, France

Countries

France

Other Identifiers

AOM09091

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

P081233

Identifier Type: -

Identifier Source: org_study_id