An observational study in Perineal Laceration, Tear, or Rupture During Delivery, sponsored by Karolinska Institutet. Enrolling by invitation at 1 site in Sweden. Open to female participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2026-04-13.
Sponsored by Karolinska Institutet · Observational
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).
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.
174 studies on the registry are indexed under Lacerations; 43 are open to participants now.
This study's planned enrollment of 1,350 is above the median of 100 across 37 observational studies indexed under Lacerations.
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Women 18-64 years undergoing their first vaginal birth which is non-instrumental with one or more live fetuses, all presentations accepted, at gestational week 34+0 or more.
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Exclusion Criteria:
Women having their first vaginal birth, which is non-instrumental.
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.
Second-degree perineal injury or worse
Perineal injury after childbirth diagnosed clinically resulting in the diagnostic codes O701, O702, or O703 (i.e. second, third or fourth degree injury).
Time frame: Within 24 hours of birth
OASI
Perineal injury affecting the external or internal anal sphincter muscles (third- or fourth-degree tear, O702 or O703).
Time frame: Within 24 hours from birth
Episiotomy
Any incision or cut in the perineum to enlarge the vaginal opening during birth.
Time frame: Immediately at birth.
Perineal or vaginal injury of any degree
All types of tears and injuries resulting from and diagnosed at childbirth.
Time frame: Within 24 hours from birth
Plan to share: Undecided — IPD can be shared with other researchers upon reasonable request, provided ethical approval and all applicable requirements have been met.
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No contact was published for this record. The registry link below has the sponsor’s details.
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