NCT07774442

Brief Summary

In France, labor induction rate is above 25.8%. Labor induction with Cook's balloon is a non-hormonal mechanical method. At Roubaix's maternity, midewifes can adminitred acupuncture therapy to help to manage this labor induction. No studies where found about an effect of acupuncture therapy on delivery provoked by labor induction with Cook's balloon.

Trial Health

63
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Trial Health Score

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

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
9mo left

Started Oct 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

August 12, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 19, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

October 15, 2026

Expected
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2027

3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2027

Last Updated

August 19, 2026

Status Verified

August 1, 2026

Enrollment Period

6 months

First QC Date

August 12, 2026

Last Update Submit

August 18, 2026

Conditions

Labor Induction

Keywords

Acupuncture therapyLabor inductionPain managementTime to delivery

Outcome Measures

Primary Outcomes (1)

  • Impact of 9 acupuncture points on time to delivery

    The primary objective will be assessed by recording the time of COOK balloon placement and the time of delivery

    Day 1

Secondary Outcomes (6)

  • Evaluate the impact of acupuncture on patient pain.

    Day 1

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

    Day 1

  • Evaluate the consumption of analgesics between the 2 groups

    Day 1

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

    Day 2

  • Comparison of balloon failure rate between the two groups

    Day 2

  • +1 more secondary outcomes

Study Arms (2)

Acupuncture arm

EXPERIMENTAL

Acupuncture therapy

Other: Acupuncture therapy

Control arm

NO INTERVENTION

usual care

Interventions

Acupuncture therapyOTHER

9 acupuncture points will be used to managed time delivery, 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

Central Study Contacts

Camille TROUILLET

CONTACT

+33 3 20 99 31 31urc@ch-roubaix.fr

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

August 12, 2026

First Posted

August 19, 2026

Study Start (Estimated)

October 15, 2026

Primary Completion (Estimated)

March 31, 2027

Study Completion (Estimated)

June 30, 2027

Last Updated

August 19, 2026

Record last verified: 2026-08

Locations

FR(1)