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NCT Number: NCT07774442

COOKACUPAIN 2 : 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.

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Key information

Conditions

Labor Induction Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

CH de Roubaix

Roubaix, 59100, France

Location contact

Caroline GUERY, Doctor

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 informed consent form

Exclusion criteria

  • patient having contraindication for the use of Cook's balloon
  • patients under curatorship and/or guardianship

Treatment and study plan

Acupuncture therapy

Other

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

Primary outcomes

  1. Impact of 9 acupuncture points on time to delivery

    Time frame: Day 1

    The primary objective will be assessed by recording the time of COOK balloon placement and the time of delivery

Secondary outcomes

  1. Evaluate the impact of acupuncture on patient pain.

    Time frame: Day 1

    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.

  2. Evaluate experiences of the patient during labor induction between the 2 groups

    Time frame: Day 1

    Use of a questionnary with lickert scale (Completely, Sufficiently, Insufficiently, Not at all)

  3. Evaluate the consumption of analgesics between the 2 groups

    Time frame: Day 1

    datas of analgesics consumption will be collected in patient record

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

    Time frame: Day 2

    percentage of Caesarean sections recorded in patients' medical records

  5. Comparison of balloon failure rate between the two groups

    Time frame: Day 2

    percentage of ballon failed procedure recorded in patients' medical records

  6. Comparison of induction duration between the two groups

    Time frame: Day 2

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

Study contacts

Contact information is provided by the study sponsor or research team.

Camille TROUILLET

CONTACT

[email protected]

+33 3 20 99 31 31

Sponsors and collaborators

Lead sponsor

Centre Hospitalier de Roubaix

Other

Registry information

Official study title

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

Acronym: COOKACUPAIN 2

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 19, 2026
Registry last updated
Aug 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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