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
The principal objective of the trial is to demonstrate that acupuncture could reduce the caesarean section rate for cervical dystocia.
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|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||142 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Care Provider)|
|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|
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.
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.
- Caesarean section rate [ Time Frame: up to 37 weeks ]Rate of caesarean section for cervical dystocia in full-time pregnancies
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
|Department of Obstetrics, Hôpital Saint-Cloud|
|Saint-Cloud, Hauts-de-Seine, France, 92211|
|Principal Investigator:||Denis COLIN, MD||Department of Obstetrics, Hôpital Saint-Cloud|