Skip to content

COOKACUPAIN 2 : Impact of Acupuncture on Delay of Delevery During Induced Labor With Cook's Balloon at the Beaumont Maternity in Roubaix

Impact of Acupuncture on Delay of Delevery During Induced Labor With Cook's Balloon at the Beaumont Maternity in Roubaix

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07774442
Acronym
COOKACUPAIN 2
Enrollment
150
Registered
2026-08-19
Start date
2026-10-15
Completion date
2027-06-30
Last updated
2026-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Labor Induction

Keywords

Acupuncture therapy, Labor induction, Pain management, Time to delivery

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.

Detailed description

Investigators aim to demonstate that acupuncture therapy during labor induction with Cook's balloon can reduced delay until delivery and improved patient's experience. Investigators will use 9 acupuncture points (7C bilateral/ 34VB bilateral/ 3F bilateral, 4GI bilateral and 4VC 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.

Interventions

OTHERAcupuncture therapy

9 acupuncture points will be used to managed time delivery, pain and improved patient's experience

Sponsors

Centre Hospitalier de Roubaix
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Impact of 9 acupuncture points on time to deliveryDay 1The primary objective will be assessed by recording the time of COOK balloon placement and the time of delivery

Secondary

MeasureTime frameDescription
Evaluate the impact of acupuncture on patient pain.Day 1Assessment of patient pain using Visual Analogic Scale scores for 1 to 10 points : before insertion of the Cook balloon, one hour after insertion, upon transfer to the delivery room, and during pushing efforts.
Evaluate experiences of the patient during labor induction between the 2 groupsDay 1Use of a questionnary with lickert scale (Completely, Sufficiently, Insufficiently, Not at all)
Evaluate the consumption of analgesics between the 2 groupsDay 1datas of analgesics consumption will be collected in patient record
Comparison of cesarean section rate, balloon failure rate and induction duration between the two groupsDay 2percentage of Caesarean sections recorded in patients' medical records
Comparison of balloon failure rate between the two groupsDay 2percentage of ballon failed procedure recorded in patients' medical records
Comparison of induction duration between the two groupsDay 2Duration in hours between begenning of labour and delivery recorded in patients' medical records

Countries

France

Contacts

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 20, 2026