Study Stopped
insufficient recruitment: 142 patients instead of 2,220 planned
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
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
2 other identifiers
interventional
142
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2014
CompletedFirst Submitted
Initial submission to the registry
March 16, 2015
CompletedFirst Posted
Study publicly available on registry
March 20, 2015
CompletedMarch 20, 2015
February 1, 2015
1.7 years
March 16, 2015
March 19, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Caesarean section rate
Rate of caesarean section for cervical dystocia in full-time pregnancies
up to 37 weeks
Study Arms (3)
acupuncture
EXPERIMENTALThe 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 acupuncture
SHAM COMPARATORThe same as active arm but with sham needles.
control group
NO INTERVENTIONStandard care, no acupuncture session.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Aged ≥ 18 years
- Signed informed consent
- Woman carrying one foetus only
- at 37 weeks (+/- 2 days) of amenorrhea
- Without contraindication to vaginal delivery
You may not qualify if:
- Prior history of caesarean section
- Non-cephalic presentation
- Fetal macrosomia
- Multiple pregnancy
- Chronic fetal hypoxia
- Placenta praevia
- Risk of neonatal contamination
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Obstetrics, Hôpital Saint-Cloud
Saint-Cloud, Hauts-de-Seine, 92211, France
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Denis COLIN, MD
Department of Obstetrics, Hôpital Saint-Cloud
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 16, 2015
First Posted
March 20, 2015
Study Start
November 1, 2012
Primary Completion
July 1, 2014
Study Completion
July 1, 2014
Last Updated
March 20, 2015
Record last verified: 2015-02