By InvitationNot Applicable

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

Sweden1,350 participantsStarted 2025-10-20

Plain-language 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).

Who can participate

Age range18 Years – 64 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Second-degree perineal injury or worse

Timeframe: Within 24 hours of birth

Trial details

NCT IDNCT07499752

SponsorKarolinska Institutet

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2027-10-20

View on ClinicalTrials.gov More Perineal Laceration, Tear, or Rupture During Delivery trials