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

NCT07499752 | Enrolling By Invitation

• 2 other identifiers: 2025-04140-01ASN 2026-1615
• Study Type: observational
• Target: 1,350
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Perineal injury; childbirth; vaginal birth; local anesthesia; pudendal nerve block; perineal protection techniques; midwifery

Outcome Measures

Primary Outcomes (1)

• Second-degree perineal injury or worse

  Perineal injury after childbirth diagnosed clinically resulting in the diagnostic codes O701, O702, or O703 (i.e. second, third or fourth degree injury).

  Within 24 hours of birth

Secondary Outcomes (2)

• OASI

  Within 24 hours from birth

• Episiotomy

  Immediately at birth.

Other Outcomes (1)

• Perineal or vaginal injury of any degree

  Within 24 hours from birth

Study Arms (1)

First vaginal birth

Women having their first vaginal birth, which is non-instrumental.

Other: Perineal protection techniques

Interventions

Perineal protection techniques OTHER

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.

First vaginal birth

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Women 18-64 years undergoing their first vaginal birth which is non-instrumental with one or more live fetuses, all presentations accepted, at gestational week 34+0 or more.

You may qualify if:

• Pregnant individuals giving birth.
• Live fetus/fetuses.
• Gestational week 34 or more at birth.
• First vaginal birth, i.e., individuals with prior cesarean section can be included.

You may not qualify if:

• Intrauterine fetal death or stillbirth.
• Labor resulting in cesarean section or instrumental delivery.

Sponsors & Collaborators

• Karolinska Institutet: lead
• Danderyd Hospital: collaborator

Study Sites (1)

Danderyd Hospital

Stockholm, 18288, Sweden

Location

MeSH Terms

Conditions

Lacerations

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Sophia Brismar Wendel, MD, PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, MD, PhD

Study Record Dates

• First Submitted: March 24, 2026
• First Posted: March 30, 2026
• Study Start: October 20, 2025
• Primary Completion (Estimated): October 20, 2027
• Study Completion (Estimated): October 20, 2027
• Last Updated: April 13, 2026

Record last verified: 2026-04

Locations

SE (1)