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)

• ClinicalTrials.gov Identifier: NCT02394041
• Recruitment Status: Terminated
• First Posted: March 20, 2015
• Last Update Posted: March 20, 2015
• Sponsor: Assistance Publique - Hôpitaux de Paris
• Information provided by (Responsible Party): Assistance Publique - Hôpitaux de Paris

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Cervical Dystocia	Device: Acupuncture; Device: Sham acupuncture	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 142 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Care Provider)
• Primary Purpose: Prevention
• Official Title: 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
• Study Start Date: November 2012
• Actual Primary Completion Date: July 2014
• Actual Study Completion Date: July 2014

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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.	Device: 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.
Sham Comparator: Sham acupuncture; The same as active arm but with sham needles.	Device: Sham acupuncture; Sham acupuncture with sham needles
No Intervention: control group; Standard care, no acupuncture session.

Outcome Measures

Primary Outcome Measures :

1. Caesarean section rate [ Time Frame: up to 37 weeks ]
   Rate of caesarean section for cervical dystocia in full-time pregnancies

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

France

Department of Obstetrics, Hôpital Saint-Cloud

Saint-Cloud, Hauts-de-Seine, France, 92211

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

Investigators

• Principal Investigator: Denis COLIN, MD; Department of Obstetrics, Hôpital Saint-Cloud

More Information

• Responsible Party: Assistance Publique - Hôpitaux de Paris
• ClinicalTrials.gov Identifier: NCT02394041 History of Changes
• Other Study ID Numbers: P081233; AOM09091 ( Other Grant/Funding Number: APHP )
• First Posted: March 20, 2015
• Last Update Posted: March 20, 2015
• Last Verified: February 2015

Keywords provided by Assistance Publique - Hôpitaux de Paris:

acupuncture; cervical dystocia; caesarean section; obstetric labor; randomized controlled trial

Additional relevant MeSH terms:

Dystocia; Obstetric Labor Complications; Pregnancy Complications