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OpenTrials
Completed

NCT Number: NCT06502418

Acupuncture to Managed Pain During Induced Labor with Cook's Balloon

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.

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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

About this study

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.

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

7 acupuncture points will be used to managed pain and improved patient's experience

Primary outcomes

  1. 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

Secondary outcomes

  1. Evaluate the consumption of analgesics between the 2 groups

    Time frame: Day 1

    datas of analgesics consumption will be collected in patient record

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

    Time frame: Day 1

    Use of questionnary

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

    Time frame: Day 2

    datas will be collected in patient record

Sponsors and collaborators

Lead sponsor

Centre Hospitalier de Roubaix

Other

Registry information

Official study title

Impact of Acupuncture on Pain Management During Induced Labor with Cook's Balloon At the Beaumont Maternity in Roubaix

Acronym: COOKACUPAIN

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 16, 2024
Registry last updated
Feb 17, 2025

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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