SOFT – Study On Fewer Tears
The SOFT study investigates whether local anaesthesia during the pushing stage can reduce the risk of perineal tears, a common complication in vaginal childbirth.
Perineal tears are the most common complication after vaginal birth. At the same time, many women giving birth receive local anaesthesia in the form of perineal infiltration and/or pudendal block during the pushing stage. Although these methods are used regularly, knowledge about their impact on perineal tear outcomes is very limited.
SOFT (Study On Fewer Tears) is a research project that aims to investigate whether local anaesthesia during the pushing stage can help reduce perineal tears.
Why is the study needed?
Preliminary results from the project’s ongoing prospective observational study show that around one third of women giving birth receive local anaesthesia in the form of infiltration, pudendal block, or both methods. Despite its widespread use, there is insufficient evidence to assess whether the treatment affects the risk of perineal tears. SOFT aims to fill this knowledge gap.
Ongoing research
Prospective observational study
In an ongoing observational study, data are being collected following vaginal births. After each birth, the responsible midwife completes a study form with information including pain relief, the baby’s presentation, the course of labour, tearing outcomes and suturing. So far, data from more than 500 births have been collected.
Interview study
Midwives and pregnant women are interviewed about their expectations regarding research into tear prevention, information provision and participation in a future study. The knowledge gained is used to design the upcoming intervention study.
Next steps
Based on the results from the ongoing sub-studies, a randomised controlled trial is planned to begin in 2027.
In the study, mepivacaine will be compared with placebo for perineal infiltration and pudendal block during the pushing stage. The aim is to investigate whether local anaesthesia can reduce the incidence of perineal tears.
Vision
SOFT aims to contribute to increased knowledge about how perineal tears can be prevented and to create a stronger scientific evidence base for the maternity care of the future.
Funding
The SOFT project has received research grants from the Allmänna BB Memorial Foundation and the Trygg-Hansa Research Foundation.
Ethics
The study has been approved by the Swedish Ethical Review Authority. 2025-04140-01, 2026-02302-02