NCT06502418

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 9, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 16, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

October 10, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 24, 2025

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 13, 2025

Completed
Last Updated

February 17, 2025

Status Verified

February 1, 2025

Enrollment Period

4 months

First QC Date

July 9, 2024

Last Update Submit

February 14, 2025

Conditions

Labor Induction

Keywords

Acupuncture therapyLabor inductionPain management

Outcome Measures

Primary Outcomes (1)

  • 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 (3)

  • Evaluate the consumption of analgesics between the 2 groups

    Day 1

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

    Day 1

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

    Day 2

Study Arms (2)

Acupuncture arm

EXPERIMENTAL

Acupuncture therapy

Other: Acupuncture therapy

Control arm

NO INTERVENTION

usual care

Interventions

Acupuncture therapyOTHER

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

Acupuncture arm

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • patient having contraindication for the use of Cook's balloon
  • patients under curatorship and/or guardianship

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CH de Roubaix

Roubaix, 59100, France

Location

MeSH Terms

Conditions

Agnosia

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 9, 2024

First Posted

July 16, 2024

Study Start

October 10, 2024

Primary Completion

January 24, 2025

Study Completion

February 13, 2025

Last Updated

February 17, 2025

Record last verified: 2025-02

Locations

FR(1)