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

Enrolling by invitation

Conditions studied: Perineal Laceration, Tear, or Rupture During Delivery

In brief

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).

Key facts

Study ID

NCT07499752

Run by

Karolinska Institutet

People needed

1350

Starts

2025-10-20

Expected to finish

2027-10-20

Last updated by the study team

2026-04-13

Who can join

Age: 18 and older, up to 64. Sex: female. Healthy volunteers: not accepted.

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.

Where it is running

• Danderyd Hospital — Stockholm, Sweden

Full record on ClinicalTrials.gov

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