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)

March 19, 2015 updated by: Assistance Publique - Hôpitaux de Paris

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

142

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Hauts-de-Seine
      • Saint-Cloud, Hauts-de-Seine, France, 92211
        • Department of Obstetrics, Hôpital Saint-Cloud

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (Actual)

July 1, 2014

Study Completion (Actual)

July 1, 2014

Study Registration Dates

First Submitted

March 16, 2015

First Submitted That Met QC Criteria

March 19, 2015

First Posted (Estimate)

March 20, 2015

Study Record Updates

Last Update Posted (Estimate)

March 20, 2015

Last Update Submitted That Met QC Criteria

March 19, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P081233
  • AOM09091 (Other Grant/Funding Number: APHP)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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