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ENROLLING BY INVITATION

NCT07499752

Study on Fewer Tears

Sponsor: Karolinska Institutet

View on ClinicalTrials.gov

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).

Official title: Study on Fewer Tears (SOFT) - The Effect of Local Anesthesia on the Incidence of Perineal Tears in First-time Mothers

Key Details

Gender

FEMALE

Age Range

18 Years - 64 Years

Study Type

OBSERVATIONAL

Enrollment

1350

Start Date

2025-10-20

Completion Date

2027-10-20

Last Updated

2026-03-30

Healthy Volunteers

Conditions

Perineal Injury Childbirth Local Analgesia Via Infiltration Pudendal Nerve Anesthesia and Analgesia Vaginal Birth After Caesarean Nulliparous Women Midwifery Perineal Laceration, Tear, or Rupture During Delivery Perineal Massage Perineal Protection Techniques

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.

Locations (1)

Danderyd Hospital

Stockholm, Sweden