Randomised Controlled Trial of the Efficacy of Acupuncture Versus Placebo on the Caesarean Section Rate in Case of Cervical Dystocia in Full-term Pregnancy
NCT02394041 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 142
Last updated 2015-03-20
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.
Conditions
- Cervical Dystocia
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
Sponsors & Collaborators
-
Assistance Publique - Hôpitaux de Paris
lead OTHER
Principal Investigators
-
Denis COLIN, MD · Department of Obstetrics, Hôpital Saint-Cloud
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2012-11-30
- Primary Completion
- 2014-07-31
- Completion
- 2014-07-31
Countries
- France
Study Locations
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