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

Cervical Dystocia Clinical Trial

— ACUCESAR  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02394041
• Other study ID #: P081233
• Secondary ID: AOM09091
• Status: Terminated
• Phase: N/A
• First received: March 16, 2015
• Last updated: March 19, 2015
• Start date: November 2012
• Est. completion date: July 2014

Study information

• Verified date: February 2015
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 142
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cervical Dystocia
• Dystocia

Intervention

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 acupuncture
Sham acupuncture with sham needles

Locations

Country	Name	City	State
France	Department of Obstetrics, Hôpital Saint-Cloud	Saint-Cloud	Hauts-de-Seine

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Caesarean section rate	Rate of caesarean section for cervical dystocia in full-time pregnancies	up to 37 weeks	No