Conservative Treatment or Resuturing Among Women With Perineal Wound Dehiscence After Vaginal Labour (HEAL)

Herlev Hospital

Status: Enrolling

Conditions: Episiotomy; Dehiscence; Secondary Perineal Tear; Dehiscence Wound

Treatments: Other: Clinical examination and pictures; Other: Questionnaire

Study type: Observational

Funder types: Other

Identifiers

NCT06026423

H-23022460

Details and patient eligibility

About

The goal of this observational study is to make us more aware of the short and long-term outcomes for women having an uncomplicated healing process after a rupture or birth cut in the perineum after giving birth in relation to a healing process with a dehisced wound treated with conservative management or secondary suturing.

Participants will be asked to do

• A gynecological examination at one month after birth and 9-12 months after birth.
• Have a picture taken of the healing process
• Answer a questionnaire at one month, three months, and 9-12 months after birth

Full description

The best way to manage perineal wound dehiscence after childbirth is unknown. Currently, there is no agreed best practice recommendation for managing perineal wound dehiscence due to a lack of evidence comparing conservative management with secondary suturing. Therefore, studies are urgently needed to compare the benefits and risks of both treatments. This study has the potential to significantly impact women´s health for those suffering from perineal wound dehiscence.

The investigators want to include 100 women who have had a primary repair of a second-degree tear or episiotomy with a normal/uncomplicated healing process, 100 women with a second-degree tear or episiotomy identified with a dehisced wound treated with secondary resuturing, and 100 women with a second-degree tear or episiotomy identified with a dehisced wound treated with conservative management.

All women who meet the inclusion criteria are recommended the same treatment and follow-up as currently present as standard care at the four hospitals that the investigators are recruiting from. The study deviates from the standard of care by offering two extra clinical examinations, one questionnaire evaluation without clinical examination, and a follow-up with pictures of the perineal tear healing process.

Enrollment: 300 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Women with a vaginal delivery who have had a primary repair of a second-degree perineal tear or episiotomy
• At least 18 years old
• Able to understand, read and speak Danish or English
• Able to give informed consent

Exclusion criteria

• None, first, third- and fourth-degree tear
• Cesarean Section

Trial design

300 participants in 3 patient groups

Normal/uncomplicated healing process

Description:

100 women with a second-degree tear or episiotomy primarily sutured after labor: identified with a normal/uncomplicated healing process

Treatment:

Other: Questionnaire

Other: Clinical examination and pictures

Dehisced wound treated with secondary resuturing

Description:

100 women with a second-degree tear or episiotomy: identified with a dehisced wound treated with secondary resuturing

Treatment:

Other: Questionnaire

Other: Clinical examination and pictures

Dehisced wound treated with conservative management

Description:

100 women with a second-degree tear or episiotomy: identified with a dehisced wound treated with conservative management

Treatment:

Other: Questionnaire

Other: Clinical examination and pictures