Clinical trial NCT06026423: Conservative Treatment or Resuturing Among Women With Perineal Wound Dehiscence After Vaginal Labour
Official title: Dehisced Perineal Tear After Vaginal Labour (HEAL) - Conservative Treatment or Resuturing
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Dehiscence Wound
Secondary Perineal Tear
Episiotomy; Dehiscence
Keywords: Dehiscence
Secondary Perineal Tear
Episiotomy
Lead sponsor: Herlev Hospital
Sponsor class: OTHER
First posted: 2023-09-07
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We want to include 100 women who have had a primary repair of a second-degree tear or episiotomy with an uncomplicated healing process. They will only be recruited from the Perineal Care Clinics at the Department of Obstetrics and Gynecology at the Copenhagen University Hospital - Herlev. Furthermore, we want to include 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. They will be recruited from the Perineal Care Clinics at the Department of Obstetrics and Gynecology at the Copenhagen University Hospitals - Rigshospitalet, Herlev Hospital, North Zealand Hospital, and Hvidovre Hospital. The women will come for a clinical examination to assess wound infection and healing 4 - 14 days post-partum.

Brief summary: 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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Body image
timeFrame: 9-12 months
Secondary outcomes:
measure: Wound healing
timeFrame: One month
measure: Infection rate
timeFrame: One month
measure: Resuming sexual intercourse
timeFrame: One month, three months, and 9-12 months
measure: Dyspareunia
timeFrame: One month, three months, and 9-12months
measure: Woman´s satisfaction with the aesthetic results of the perineal wound
timeFrame: One month, three months, and 9-12 months
measure: Affected breastfeeding
timeFrame: One month, three months, and 9-12 months
measure: Re-admission
timeFrame: Within one month
measure: Prolapse
timeFrame: One month, three months, and 9-12 months
measure: Urinary incontinence
timeFrame: One month, three months, and 9-12 months
measure: Fecal incontinence
timeFrame: One month, three months, and 9-12 months
measure: Psychological well-being (maternal anxiety or depression)
timeFrame: Three months, and 9-12 months
measure: Pain intensity
timeFrame: One month, three months, and 9-12 months
measure: Consuming painkillers because of pain due to perineal tear
timeFrame: One month, three months, and 9-12 months
measure: Pelvic floor muscle contraction
timeFrame: One month and 9-12 months
Other outcomes:
Locations:
city: Herlev
country: Denmark
facility: Department of Obstetrics and Gynaecology, Copenhagen University Hospital - Herlev and Gentofte
Study officials:
affiliation: Copenhagen University Hospital - Herlev and Gentofte
name: Hanna M. Jangö, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: