Perineal Laceration, Tear, or Rupture During Delivery
Conditions
Keywords
Perineal injury, childbirth, vaginal birth, local anesthesia, pudendal nerve block, perineal protection techniques, midwifery
Brief 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).
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
OTHERPerineal 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.
Sponsors
Karolinska Institutet
Danderyd Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 64 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Second-degree perineal injury or worse | Within 24 hours of birth | Perineal injury after childbirth diagnosed clinically resulting in the diagnostic codes O701, O702, or O703 (i.e. second, third or fourth degree injury). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| OASI | Within 24 hours from birth | Perineal injury affecting the external or internal anal sphincter muscles (third- or fourth-degree tear, O702 or O703). |
| Episiotomy | Immediately at birth. | Any incision or cut in the perineum to enlarge the vaginal opening during birth. |
Countries
Sweden
Contacts
PRINCIPAL_INVESTIGATORSophia Brismar Wendel, MD, PhD
Karolinska Institutet
Outcome results
None listed