Labor InductionCOOKACUPAIN 2NCT07774442
COOKACUPAIN 2 : Impact of Acupuncture on Delay of Delevery During Induced Labor With Cook's Balloon at the Beaumont Maternity in Roubaix
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. At Roubaix's maternity, midewifes can adminitred acupuncture therapy to help to manage this labor induction. 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
- 150 participants
- Where
- 1 siteFrance
- Study dates
- 15 Oct 2026to 30 Jun 2027
- Phase
- Interventional
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. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Impact of Acupuncture on Delay of Delevery 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.
At Roubaix's maternity, midewifes can adminitred acupuncture therapy to help to manage this labor induction.
No studies where found about an effect of acupuncture therapy on delivery 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 delay until delivery and improved patient's experience. Investigators will use 9 acupuncture points (7C bilateral/ 34VB bilateral/ 3F bilateral, 4GI bilateral and 4VC 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, Time to delivery
- 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
9 acupuncture points will be used to managed time delivery, 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 9 acupuncture points on time to delivery
The primary objective will be assessed by recording the time of COOK balloon placement and the time of delivery
Measured: Day 1
Secondary outcomes (6)
Evaluate the impact of acupuncture on patient pain.
Assessment of patient pain using Visual Analogic Scale scores for 1 to 10 points : before insertion of the Cook balloon, one hour after insertion, upon transfer to the delivery room, and during pushing efforts.
Measured: Day 1
Evaluate experiences of the patient during labor induction between the 2 groups
Use of a questionnary with lickert scale (Completely, Sufficiently, Insufficiently, Not at all)
Measured: Day 1
Evaluate the consumption of analgesics between the 2 groups
datas of analgesics consumption will be collected in patient record
Measured: Day 1
Comparison of cesarean section rate, balloon failure rate and induction duration between the two groups
percentage of Caesarean sections recorded in patients' medical records
Measured: Day 2
Comparison of balloon failure rate between the two groups
percentage of ballon failed procedure recorded in patients' medical records
Measured: Day 2
Comparison of induction duration between the two groups
Duration in hours between begenning of labour and delivery recorded in patients' medical records
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 posted19 Aug 2026
- Study start15 Oct 2026 (estimated)
- Primary completion31 Mar 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
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
- 150 participants (estimated)
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
- NCT07774442
- Sponsor's protocol ID
- 2025-007
- Other IDs
- 2026-A01789-42
- Acronym
- COOKACUPAIN 2
- Status last verified
- Aug 2026
- First submitted
- 12 Aug 2026
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No