Conservative Treatment or Resuturing Among Women With Perineal Wound Dehiscence After Vaginal Labour
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorHerlev Hospital
About this trial
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
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
None, first, third- and fourth-degree tear
Cesarean Section
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Clinical examination and pictures
Other interventionA clinical examination is needed to assess the healing process for the three groups. After assessing the healing process, we will take pictures of the tear for documentation.
Questionnaire
Other interventionThe participant will answer questions, serving as a baseline questionnaire, when arriving at the clinical examination one month post-partum. At three and 9-12 months post-postpartum, they will receive another questionnaire. The questionnaire will consist of validated questions regarding body image, pain, Urogynecological problems as symptoms of prolapse, urinary and anal incontinence, and questions about sexual problems.
Treatment groups
300 Participants
are divided into 3 treatment groupsGroup A: Normal/uncomplicated healing process2 interventions
Group B: Dehisced wound treated with secondary resuturing2 interventions
Group C: Dehisced wound treated with conservative management2 interventions
Trial outcomes
Primary outcomes
1
Body image
Measured by the Body-Image questionnaire FGSIS - Female Genital Self-Image Scale
Time frame
9-12 monthsSecondary outcomes
1
Wound healing
The proportion of women with healed wounds at one month post-partum assessed by clinical examination and REEDA scale (Redness, Oedema, Ecchymosis, Discharge, Approximation of the wound edges). The REEDA scale contains five criteria each receiving a score between 0 and 3. The total score range from 0 - 15 with lower scores representing better-wound healing
Time frame
One month2
Infection rate
The proportion of women with an infected wound until one month post-partum assessed by clinical examination and measured by REEDA scale
Time frame
One month3
Resuming sexual intercourse
Measured by the PISQ-12 questionnaire which is a short form of the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12)
Time frame
One month, three months, and 9-12 months4
Dyspareunia
Measured by the PISQ-12 questionnaire which is a short form of the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12)
Time frame
One month, three months, and 9-12monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov