Perineal Laceration, Tear, or Rupture During DeliverySOFTNCT07499752
Study on Fewer Tears (SOFT) - The Effect of Local Anesthesia on the Incidence of Perineal Tears in the First Vaginal Birth
An observational study of Perineal Laceration, Tear, or Rupture During Delivery, run by Karolinska Institutet at 1 site in Sweden.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 64 years, women only
- Conditions the study is for
- Perineal Laceration, Tear, or Rupture During Delivery
- What is being tested?
- Perineal protection techniques
- How many people
- 1,350 participants
- Where
- 1 siteSweden
- Study dates
- 20 Oct 2025to 20 Oct 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- Women only
- No healthy volunteers
- Adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- Intrauterine fetal death or stillbirth.
- Labor resulting in cesarean section or instrumental delivery.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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).
Read the 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.
- Being tested
- Perineal protection techniques
- Keywords
- Perineal injury, childbirth, vaginal birth, local anesthesia, pudendal nerve block, perineal protection techniques, midwifery
- Medical subject headings
- Lacerations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perineal protection techniquesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| First vaginal birth | Women having their first vaginal birth, which is non-instrumental. Receives: Other: Perineal protection techniques |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Within 24 hours of birth
Secondary outcomes (2)
OASI
Perineal injury affecting the external or internal anal sphincter muscles (third- or fourth-degree tear, O702 or O703).
Measured: Within 24 hours from birth
Episiotomy
Any incision or cut in the perineum to enlarge the vaginal opening during birth.
Measured: Immediately at birth.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2026
- Study start20 Oct 2025
- Primary completion20 Oct 2027 (estimated)
- Study completion20 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perineal Laceration, Tear, or Rupture During DeliveryStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Danderyd Hospital
- Responsible party
- Principal investigator, Sophia Brismar Wendel, Karolinska Institutet
- Investigators
- Sophia Brismar Wendel, MD, PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07499752
- Sponsor's protocol ID
- 2025-04140-01
- Other IDs
- ASN 2026-1615, 2025
- Acronym
- SOFT
- Status last verified
- Apr 2026
- First submitted
- 24 Mar 2026
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: IPD can be shared with other researchers upon reasonable request, provided ethical approval and all applicable requirements have been met.
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Fewer Tears (SOFT) - The Effect of Local Anesthesia on the Incidence of Perineal Tears in the First Vaginal Birth
- ClinicalTrials.gov ID
- NCT07499752
- Acronym / sponsor ID
- SOFT / 2025-04140-01
- Keywords
- Perineal injury, childbirth, vaginal birth, local anesthesia, pudendal nerve block, perineal protection techniques, midwifery
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 1,350 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Danderyd Hospital
- Study start
- 20 Oct 2025 (actual)
- Primary completion
- 20 Oct 2027 (estimated)
- Study completion
- 20 Oct 2027 (estimated)
- First posted
- 30 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| First vaginal birth | – | Other: Perineal protection techniquesWomen having their first vaginal birth, which is non-instrumental. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- Intrauterine fetal death or stillbirth.
- Labor resulting in cesarean section or instrumental delivery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Perineal protection techniquesPerineal 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. | Other | First vaginal birth |
Primary outcome
Second-degree perineal injury or worse
Time frame: 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).
2 secondary outcomes
OASI
Time frame: Within 24 hours from birth
Episiotomy
Time frame: Immediately at birth.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Individual participant dataSharing planned: 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sophia Brismar Wendel, MD, PhD principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Perineal Laceration, Tear, or Rupture During Delivery, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Second-degree perineal injury or worse (time frame: Within 24 hours of birth). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.