Clinical Trial

Study on Fewer Tears (SOFT) - The Effect of Local Anesthesia on the Incidence of Perineal Tears in the First Vaginal Birth

Study acronym: SOFT
Enrolling by Invitation
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Summary
The SOFT study investigates whether local anaesthesia during the second stage of labor decreases the incidence of perineal tears, including sphincter injuries, in women with their first vaginal birth (non-instrumental).
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2026-03-24.
Trial Details
NCT Number NCT07499752
Lead Sponsor Karolinska Institutet
Collaborators: Danderyd Hospital
Conditions Perineal Laceration, Tear, or Rupture During Delivery
Enrollment 1,350 participants
Start Date 2025-10-20
Primary Completion 2027-10-20 (estimated)
Study Completion 2027-10-20 (estimated)
Updated on ClinicalTrials.gov 2026-04-13