Study on Fewer Tears (SOFT) - The Effect of Local Anesthesia on the Incidence of Perineal Tears in the First Vaginal Birth
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Perineal protection techniques.
- Who it may be relevant to
- Registry conditions: Perineal Laceration, Tear, or Rupture During Delivery. Basic parameters: 18 years — 64 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Sweden
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
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.
Primary outcome measures
- Second-degree perineal injury or worse [Time frame: Within 24 hours of birth]
Secondary outcome measures (2)
- OASI [Time frame: Within 24 hours from birth]
- Episiotomy [Time frame: Immediately at birth.]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- Intrauterine fetal death or stillbirth.
- Labor resulting in cesarean section or instrumental delivery.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Sweden · 1 center
- Danderyd Hospital — Stockholm
Identifiers
NCT: NCT07499752 · 2025-04140-01 · ASN 2026-1615