NCT02394041

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

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 142 (actual)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Cervical Dystocia

Interventions

Type	Name	Description
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

Timeline

• Start date: 2012-11-01
• Primary completion: 2014-07-01
• Completion: 2014-07-01
• First posted: 2015-03-20
• Last updated: 2015-03-20

Locations

1 site across 1 country: France