Status:
ACTIVE_NOT_RECRUITING
MILTA vs Placebo Use Comparison for the Management of Pain Related to Perineal Scars Following Delivery
Lead Sponsor:
Centre Hospitalier Universitaire, Amiens
Conditions:
Perineal Scars
Delivery Complication
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
The incidence of perineal scars after a pregnancy is high, either related to an episiotomy or to spontaneous perineal tears. These perineal scars can result in acute pain but also in chronic pain for ...
Eligibility Criteria
Inclusion
- vaginal delivery less than 24h before inclusion
- perineal scar with pain assessed as \> 3/10 with a numerical scale
- 18-years-old or older
- registration to the French medical system
- speaking and writing French
- written informed consent signed
Exclusion
- woman under 18-years-old
- woman under law liberty restriction
- women unable to understand the written informed consent
- no written informed consent signed
- previous perineal surgery
- delivery with a caesarian section
- vaginal delivery with no perineal scar
- vaginal delivery with infected perineal scar
- women with restrictions for the use of level 1 analgesic
- women requiring level 2 or 3 analgesics for other reasons
Key Trial Info
Start Date :
January 31 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 23 2025
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT05345600
Start Date
January 31 2022
End Date
November 23 2025
Last Update
November 19 2025
Active Locations (1)
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1
CHU Amiens Picardie
Amiens, Picardie, France, 80054