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Not yet recruitingNCT07774442COOKACUPAIN 2Updated Aug 19, 2026

COOKACUPAIN 2 : Impact of Acupuncture on Delay of Delevery During Induced Labor With Cook's Balloon at the Beaumont Maternity in Roubaix

An interventional study of Acupuncture therapy in Labor Induction, sponsored by Centre Hospitalier de Roubaix. Not yet recruiting at 1 site in France. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-19.

Sponsored by Centre Hospitalier de Roubaix · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
150
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study 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.

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.

02

Conditions studied

  • Labor Induction

Keywords

  • Acupuncture therapy
  • Labor induction
  • Pain management
  • Time to delivery
03

In context

Lead sponsor

Centre Hospitalier de Roubaix is the lead sponsor of 9 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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 form

Exclusion criteria

Exclusion Criteria:

  • patient having for the use of Cook's balloon
  • patients under curatorship and/or guardianship
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
150 participants (estimated)

Study arms

  • Experimental
    Acupuncture arm

    Acupuncture therapy

    Other: Acupuncture therapy

  • No intervention
    Control arm

    usual care

Interventions

  • OtherAcupuncture therapy

    9 acupuncture points will be used to managed time delivery, pain and improved patient's experience

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Day 1

Secondary outcomes

  1. 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.

    Time frame: Day 1

  2. 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)

    Time frame: Day 1

  3. Evaluate the consumption of analgesics between the 2 groups

    datas of analgesics consumption will be collected in patient record

    Time frame: Day 1

  4. Comparison of cesarean section rate, balloon failure rate and induction duration between the two groups

    percentage of Caesarean sections recorded in patients' medical records

    Time frame: Day 2

  5. Comparison of balloon failure rate between the two groups

    percentage of ballon failed procedure recorded in patients' medical records

    Time frame: Day 2

  6. Comparison of induction duration between the two groups

    Duration in hours between begenning of labour and delivery recorded in patients' medical records

    Time frame: Day 2

07

Study locations

1 site
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 19, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07774442
Lead sponsor
Centre Hospitalier de Roubaix
Responsible party
Sponsor
First posted
Aug 19, 2026
Start date
Oct 15, 2026 (estimated)
Primary completion
Mar 31, 2027 (estimated)
Completion
Jun 30, 2027 (estimated)
Last update
Aug 19, 2026

Study contacts

Camille TROUILLET
Contact
urc@ch-roubaix.fr
+33 3 20 99 31 31

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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