Status:
COMPLETED
Efficacy of the Photobiomodulation on the Pelvi-perineal Pain in Immediate Post-partum Situation
Lead Sponsor:
Elsan
Conditions:
Pelvic Pain
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
Photobiomodulation (PBM), evaluated in this study, will be delivered by a CE marked class IIa medical device (MILTA technology), composed of a panel that gathers 18 emitters. This is an innovative, al...
Detailed Description
In a woman's life, maternity is an important stage that is not without consequences, not only in daily life but also in future life. Perineal pain syndrome is a problem frequently encountered in the p...
Eligibility Criteria
Inclusion
- Woman aged 18 years or older
- Primi or multiparous patient
- Natural childbirth, regardless of the method of extraction (spontaneous, vacuum, forceps), and damage to the perineum (simple tear, episiotomy, obstetric anal sphincter injury)
- Patients affiliated to a health insurance plan
- Agreeing to participate in the study and having signed an informed consent
Exclusion
- Immediate complications related to the childbirth and requiring management in the continuing care unit (delivery haemorrhage, eclampsia, etc.)
- Severe neonatal complications requiring reanimation.
- Patient with a cardiac pacemaker
- Presence of a disease and/or taking photo-sensitising treatment
- Patient under legal protection
Key Trial Info
Start Date :
May 6 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 12 2023
Estimated Enrollment :
480 Patients enrolled
Trial Details
Trial ID
NCT04896034
Start Date
May 6 2021
End Date
May 12 2023
Last Update
February 29 2024
Active Locations (1)
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1
Clinique la Chataigneraie
Beaumont, France, 63110