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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)

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ClinicalTrials.gov Identifier: NCT02394041
Recruitment Status : Terminated (insufficient recruitment: 142 patients instead of 2,220 planned)
First Posted : March 20, 2015
Last Update Posted : March 20, 2015
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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.


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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

Resource links provided by the National Library of Medicine


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.



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



Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02394041


Locations
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France
Department of Obstetrics, Hôpital Saint-Cloud
Saint-Cloud, Hauts-de-Seine, France, 92211
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Denis COLIN, MD Department of Obstetrics, Hôpital Saint-Cloud

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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    Key Record Dates
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:
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Dystocia
Obstetric Labor Complications
Pregnancy Complications