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

February 14, 2025 updated by: Centre Hospitalier de Roubaix

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

72

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Roubaix, France, 59100
        • CH de Roubaix

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Acupuncture arm
Acupuncture therapy
Other: Acupuncture therapy
7 acupuncture points will be used to managed pain and improved patient's experience
No Intervention: Control arm
usual care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate the consumption of analgesics between the 2 groups
Time Frame: Day 1
datas of analgesics consumption will be collected in patient record
Day 1
Evaluate experiences of the patient during labor induction between the 2 groups
Time Frame: Day 1
Use of questionnary
Day 1
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
Day 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier de Roubaix

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 10, 2024

Primary Completion (Actual)

January 24, 2025

Study Completion (Actual)

February 13, 2025

Study Registration Dates

First Submitted

July 9, 2024

First Submitted That Met QC Criteria

July 9, 2024

First Posted (Actual)

July 16, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 14, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2023-008

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe