Acupuncture to Managed Pain During Induced Labor with Coo... | NCT06502418

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

NCT06502418

Sponsor

Centre Hospitalier de Roubaix

Status

Completed

Last Update Posted

Feb 17, 2025Actual

Enrollment

72Actual

Phase

Not Applicable

Conditions

Labor Induction

Interventions

Acupuncture therapy

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 10, 2024Actual

Primary Completion Date

Jan 24, 2025Actual

Completion Date

Feb 13, 2025Actual

First Submitted Date

Jul 9, 2024

First Submission Date that Met QC Criteria

Jul 9, 2024

First Posted Date

Jul 16, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 14, 2025

Last Update Posted Date

Feb 17, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

72Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Acupuncture arm	Experimental	Acupuncture therapy	Other: Acupuncture therapy
Control arm	No Intervention	usual care

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Acupuncture therapy	Other	7 acupuncture points will be used to managed pain and improved patient's experience	Acupuncture arm

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Impact of 7 acupuncture points on pain	Assessment of pain with Visual Analogic Scale before and after the use of Cook's balloon	Day 1

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
CH de Roubaix		Roubaix		59100	France

Condition Browse Module

MeSH Terms

ID	Term
D000377	Agnosia

Ancestor Terms

ID	Term
D010468	Perceptual Disorders
D019954	Neurobehavioral Manifestations
D009461	Neurologic Manifestations
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D015670	Acupuncture Therapy

Ancestor Terms

ID	Term
D000529	Complementary Therapies
D013812	Therapeutics

Browse Leaves

Not provided

Browse Branches

Not provided