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

NCT ID: NCT06502418

Last Updated: 2025-02-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-10

Study Completion Date

2025-02-13

Brief Summary

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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

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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.

Conditions

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Labor Induction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Acupuncture arm

Acupuncture therapy

Group Type EXPERIMENTAL

Acupuncture therapy

Intervention Type OTHER

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

Control arm

usual care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Acupuncture therapy

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier de Roubaix

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CH de Roubaix

Roubaix, , France

Site Status

Countries

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France

Other Identifiers

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2023-008

Identifier Type: -

Identifier Source: org_study_id

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