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

NCT07499752 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 1350

Last updated 2026-04-13

No results posted yet for this study

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).

Conditions

  • Perineal Laceration, Tear, or Rupture During Delivery

Interventions

OTHER

Perineal protection techniques

Perineal protection techniques used by the midwife during a non-instrumental vaginal birth including wet-warm compresses, verbal guidance, oil/gel, perineal massage, two midwives support, pressure relieving position, manual control of the speed of the head's birth, two-step technique, C-grip or Finnish grip for manual perineal protection, supporting the perineum during the delivery of the shoulders, breathing technique during pushing, water birth, acupuncture.

Sponsors & Collaborators

Principal Investigators

  • Sophia Brismar Wendel, MD, PhD · Karolinska Institutet

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-20
Primary Completion
2027-10-20
Completion
2027-10-20

Countries

  • Sweden

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07499752 on ClinicalTrials.gov