Labor InductionCOOKACUPAINNCT06502418
Acupuncture to Managed Pain During Induced Labor with Cook's Balloon
A study testing Acupuncture therapy in people with Labor Induction, run by Centre Hospitalier de Roubaix at 1 site in France.
Trial summary
In France, labor induction rate is above 25.8%. Labor induction with Cook's balloon is a non-hormonal mechanical method but this technique can provide pain. At Roubaix's maternity, midewifes can adminitred acupuncture therapy to help to manage this pain. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Labor Induction
- What is being tested?
- Acupuncture therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteFrance
- Study dates
- 10 Oct 2024to 13 Feb 2025
- 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
- pregnant woman with a gestational age of 37 weeks and above
- age>=18 years old
- having medical indication to be labor induced by Cook's Balloon
- speaking French
- agreeing to participate by signing informed consent form
Who cannot join
- patient having contraindication for the use of Cook's balloon
- patients under curatorship and/or guardianship
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Acupuncture on Pain Management During Induced Labor with Cook's Balloon At the Beaumont Maternity in Roubaix
In France, labor induction rate is above 25.8%. Labor induction with Cook's balloon is a non-hormonal mechanical method but this technique can provide pain.
At Roubaix's maternity, midewifes can adminitred acupuncture therapy to help to manage this pain.
No studies where found about an effect of acupuncture therapy on pain provoked by labor induction with Cook's balloon.
Read the detailed description
Investigators aim to demonstate that acupuncture therapy during labor induction with Cook's balloon can reduced pain and improved patient's experience. Investigators will use 7 acupuncture points (YIN TANG/ 4 GI bilateral/ 36 E bilateral and 5TR bilateral) before the application of the balloon. A visual analog scale will be used before and after balloon insertion to collect pain level.
a questionnary will be filled by patient to collect their experiences. Investigators will collect data about analgesia, failed of induction and cesarean section to see effect of acupuncture on them.
Patients will be randomised.
- Conditions
- Labor Induction
- Being tested
- Acupuncture therapy
- Keywords
- Acupuncture therapy, Labor induction, Pain management
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acupuncture therapyOther
7 acupuncture points will be used to managed pain and improved patient's experience
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture arm | Experimental | Acupuncture therapy Receives: Other: Acupuncture therapy |
| Control arm | No intervention | usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of 7 acupuncture points on pain
Assessment of pain with Visual Analogic Scale before and after the use of Cook's balloon
Measured: Day 1
Secondary outcomes (3)
Evaluate the consumption of analgesics between the 2 groups
datas of analgesics consumption will be collected in patient record
Measured: Day 1
Evaluate experiences of the patient during labor induction between the 2 groups
Use of questionnary
Measured: Day 1
Comparison of cesarean section rate, balloon failure rate and induction duration between the two groups
datas will be collected in patient record
Measured: Day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2024
- Study start10 Oct 2024
- Primary completion24 Jan 2025
- Study completion13 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Labor InductionStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier de Roubaix
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06502418
- Sponsor's protocol ID
- 2023-008
- Acronym
- COOKACUPAIN
- Status last verified
- Feb 2025
- First submitted
- 9 Jul 2024
- Last updated
- 17 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Acupuncture on Pain Management During Induced Labor with Cook's Balloon At the Beaumont Maternity in Roubaix
- ClinicalTrials.gov ID
- NCT06502418
- Acronym / sponsor ID
- COOKACUPAIN / 2023-008
- Conditions
- Labor Induction
- Keywords
- Acupuncture therapy, Labor induction, Pain management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Centre Hospitalier de RoubaixUniversity, hospital or other
- Study start
- 10 Oct 2024 (actual)
- Primary completion
- 24 Jan 2025 (actual)
- Study completion
- 13 Feb 2025 (actual)
- First posted
- 16 Jul 2024 (actual)
- 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.
In France, labor induction rate is above 25.8%. Labor induction with Cook's balloon is a non-hormonal mechanical method but this technique can provide pain.
At Roubaix's maternity, midewifes can adminitred acupuncture therapy to help to manage this pain.
No studies where found about an effect of acupuncture therapy on pain provoked by labor induction with Cook's balloon.
Detailed description
Investigators aim to demonstate that acupuncture therapy during labor induction with Cook's balloon can reduced pain and improved patient's experience. Investigators will use 7 acupuncture points (YIN TANG/ 4 GI bilateral/ 36 E bilateral and 5TR bilateral) before the application of the balloon. A visual analog scale will be used before and after balloon insertion to collect pain level.
a questionnary will be filled by patient to collect their experiences. Investigators will collect data about analgesia, failed of induction and cesarean section to see effect of acupuncture on them.
Patients will be randomised.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acupuncture arm | Experimental | Other: Acupuncture therapyAcupuncture therapy |
| Control arm | No intervention | –usual care |
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)
- pregnant woman with a gestational age of 37 weeks and above
- age>=18 years old
- having medical indication to be labor induced by Cook's Balloon
- speaking French
- agreeing to participate by signing informed consent form
Key exclusion criteria (2 listed)
- patient having contraindication for the use of Cook's balloon
- patients under curatorship and/or guardianship
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 |
|---|---|---|
| Acupuncture therapy7 acupuncture points will be used to managed pain and improved patient's experience | Other | Acupuncture arm |
Primary outcome
Impact of 7 acupuncture points on pain
Time frame: Day 1
Assessment of pain with Visual Analogic Scale before and after the use of Cook's balloon
3 secondary outcomes
Evaluate the consumption of analgesics between the 2 groups
Time frame: Day 1
Evaluate experiences of the patient during labor induction between the 2 groups
Time frame: Day 1
Comparison of cesarean section rate, balloon failure rate and induction duration between the two groups
Time frame: Day 2
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 therapy in people with Labor Induction, run by Centre Hospitalier de Roubaix 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 2 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: finished, as of the sponsor's last update on 17 Feb 2025. 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. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Impact of 7 acupuncture points on pain (time frame: Day 1). 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 17 Feb 2025.