NCT07499752

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

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 1,350 (estimated)
• Sponsor: Karolinska Institutet · Academic / Other
• Sex: Female
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

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).

Detailed description

Introduction Perineal tears are the most common complications of vaginal birth. Severe tears can cause long-term physical and psychological morbidity. Preliminary observations suggest that pudendal block and perineal infiltration with local anaesthesia may relax the pelvic floor muscles, reduce pain, and facilitate a more controlled pushing phase. 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). Materials and Methods Data collection for a prospective observational study is ongoing at Danderyd University Hospital. The study documents perineal protection techniques and the incidence of perineal tears in women with their first vaginal birth (non-instrumental). Findings from this preparatory study will guide the design of a randomized, double-blind, controlled trial to evaluate whether pudendal block and perineal infiltration with mepivacaine or placebo have a protective effect on perineal trauma. The aim is to include 1,350 participants in this observational study. Midwives complete a case report form indicating the use of manual perineal protection, fetal presentation and position, the duration of the second stage, the detailed degree of perineal tear, pain management during the pushing phase, and the need for local anaesthesia during suturing. The full analysis will evaluate associations among perineal protection techniques, local anaesthesia, and the incidence and severity of perineal tears.

Conditions

• Perineal Laceration, Tear, or Rupture During Delivery

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-10-20
• Primary completion: 2027-10-20
• Completion: 2027-10-20
• First posted: 2026-03-30
• Last updated: 2026-04-13

Locations

1 site across 1 country: Sweden