Cervical DystociaACUCESARNCT02394041
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 study testing Acupuncture in people with Cervical Dystocia, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervical Dystocia
- What is being tested?
- Acupuncture
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 142 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2012to Jul 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged ≥ 18 years
- Signed informed consent
- Woman carrying one foetus only
- at 37 weeks (+/- 2 days) of amenorrhea
- Without contraindication to vaginal delivery
Who cannot join
- Prior history of caesarean section
- Non-cephalic presentation
- Fetal macrosomia
- Multiple pregnancy
- Chronic fetal hypoxia
- Placenta praevia
- Risk of neonatal contamination
Trial locations and contacts
1 site in 1 country.
France1 site
Department of Obstetrics, Hôpital Saint-Cloud
Saint-Cloud, Hauts-de-Seine, 92211
About this study
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
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.
Read the 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
- Being tested
- Acupuncture, Sham acupuncture
- Keywords
- acupuncture, cervical dystocia, caesarean section, obstetric labor, randomized controlled trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureDevice
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 acupunctureDevice
Sham acupuncture with sham needles
| Study group | Role | What they receive |
|---|---|---|
| acupuncture | Experimental | 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. Receives: Device: Acupuncture |
| Sham acupuncture | Sham comparator | The same as active arm but with sham needles. Receives: Device: Sham acupuncture |
| control group | No intervention | Standard care, no acupuncture session. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Caesarean section rate
Rate of caesarean section for cervical dystocia in full-time pregnancies
Measured: up to 37 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2015 (estimated)
- Study startNov 2012
- Primary completionJul 2014
- Study completionJul 2014
Why it stopped: insufficient recruitment: 142 patients instead of 2,220 planned
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical DystociaStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Denis COLIN, MD, Principal investigator, Department of Obstetrics, Hôpital Saint-Cloud
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02394041
- Sponsor's protocol ID
- P081233
- Other IDs
- AOM09091
- Acronym
- ACUCESAR
- Status last verified
- Feb 2015
- First submitted
- 16 Mar 2015
- Last updated
- 20 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02394041
- Acronym / sponsor ID
- ACUCESAR / P081233
- Conditions
- Cervical Dystocia
- Keywords
- acupuncture, cervical dystocia, caesarean section, obstetric labor, randomized controlled trial
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: insufficient recruitment: 142 patients instead of 2,220 planned
- Enrolment
- 142 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 20 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| acupuncture | Experimental | Device: AcupunctureThe 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 comparator | Device: Sham acupunctureThe same as active arm but with sham needles. |
| control group | No intervention | –Standard care, no acupuncture session. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged ≥ 18 years
- Signed informed consent
- Woman carrying one foetus only
- at 37 weeks (+/- 2 days) of amenorrhea
- Without contraindication to vaginal delivery
Key exclusion criteria (7 listed)
- Prior history of caesarean section
- Non-cephalic presentation
- Fetal macrosomia
- Multiple pregnancy
- Chronic fetal hypoxia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcupunctureMethod 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 | acupuncture |
| Sham acupunctureSham acupuncture with sham needles | Device | Sham acupuncture |
Primary outcome
Caesarean section rate
Time frame: up to 37 weeks
Rate of caesarean section for cervical dystocia in full-time pregnancies
Results and safety
The study was stopped early (reason given: insufficient recruitment: 142 patients instead of 2,220 planned). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2015.
Related trials for Cervical Dystocia
Recruiting
Effects of Systematic Cervical Exam Training on Labor and Delivery Care
Delivery Problem, Cervix; Pregnancy
RecruitingPhase 2/3
Anticholinergics for Cervical Edema in Labor
Labor Dystocia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Denis COLIN, MD principal investigator
Department of Obstetrics, Hôpital Saint-Cloud
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture in people with Cervical Dystocia, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: insufficient recruitment: 142 patients instead of 2,220 planned). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Caesarean section rate (time frame: up to 37 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2015.