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

C

Centre Hospitalier de Roubaix

Status

Completed

Conditions

Labor Induction

Treatments

Other: Acupuncture therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT06502418
2023-008

Details and patient eligibility

About

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.

Full 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.

Enrollment

72 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

72 participants in 2 patient groups

Acupuncture arm
Experimental group
Description:
Acupuncture therapy
Treatment:
Other: Acupuncture therapy
Control arm
No Intervention group
Description:
usual care

Trial contacts and locations

1

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Central trial contact

Camille TROUILLET

Data sourced from clinicaltrials.gov

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