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

Overview

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 Title of Study: “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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Double (Participant, Care Provider)
  • Study Primary Completion Date: July 2014

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.

Interventions

  • 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.
  • Device: Sham acupuncture
    • Sham acupuncture with sham needles

Arms, Groups and Cohorts

  • 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.
  • Sham Comparator: Sham acupuncture
    • The same as active arm but with sham needles.
  • No Intervention: control group
    • Standard care, no acupuncture session.

Clinical Trial Outcome Measures

Primary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Assistance Publique – Hôpitaux de Paris
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Denis COLIN, MD, Principal Investigator, Department of Obstetrics, Hôpital Saint-Cloud

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