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

Not Applicable

Completed

• Conditions: Labor Induction
• Interventions: Other: Acupuncture therapy

• Registration Number: NCT06502418
• Lead Sponsor: Centre Hospitalier de Roubaix

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.

Study Timeline

• Study First Submitted: 2024-07-09
• Study First Submitted QC: 2024-07-09
• Study First Posted: 2024-07-16
• Study Start: 2024-10-10
• Primary Completion: 2025-01-24
• Status Verified: 2025-02
• Study Completion: 2025-02-13
• Last Update Submitted: 2025-02-14
• Last Update Posted: 2025-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 72

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Acupuncture arm	Acupuncture therapy	Acupuncture therapy

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Comparison of cesarean section rate, balloon failure rate and induction duration between the two groups	Day 2	datas will be collected in patient record
Evaluate experiences of the patient during labor induction between the 2 groups	Day 1	Use of questionnary
Evaluate the consumption of analgesics between the 2 groups	Day 1	datas of analgesics consumption will be collected in patient record

Trial Locations

Locations (1)

CH de Roubaix; 🇫🇷 Roubaix, France