Dehiscence WoundHEALNCT06026423
Conservative Treatment or Resuturing Among Women With Perineal Wound Dehiscence After Vaginal Labour
An observational study of Dehiscence Wound and Secondary Perineal Tear, run by Herlev Hospital at 1 site in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Dehiscence Wound, Secondary Perineal Tear, Episiotomy; Dehiscence
- What is being tested?
- Clinical examination and pictures and Questionnaire
- How many people
- 302 participants
- Where
- 1 siteDenmark
- Study dates
- 15 Sep 2023to 20 Aug 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- None, first, third- and fourth-degree tear
- Cesarean Section
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Obstetrics and Gynaecology, Copenhagen University Hospital - Herlev and Gentofte
Herlev, DK-2730
About this study
Official title: Dehisced Perineal Tear After Vaginal Labour (HEAL) - Conservative Treatment or Resuturing
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
Read the 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.
- Being tested
- Clinical examination and pictures, Questionnaire
- Keywords
- Dehiscence, Secondary Perineal Tear, Episiotomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical examination and picturesOther
A 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.
QuestionnaireOther
The 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.
| Study group | Role | What they receive |
|---|---|---|
| Normal/uncomplicated healing process | 100 women with a second-degree tear or episiotomy primarily sutured after labor: identified with a normal/uncomplicated healing process Receives: Other: Clinical examination and pictures; Other: Questionnaire | |
| Dehisced wound treated with secondary resuturing | 100 women with a second-degree tear or episiotomy: identified with a dehisced wound treated with secondary resuturing Receives: Other: Clinical examination and pictures; Other: Questionnaire | |
| Dehisced wound treated with conservative management | 100 women with a second-degree tear or episiotomy: identified with a dehisced wound treated with conservative management Receives: Other: Clinical examination and pictures; Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body image
Measured by the Body-Image questionnaire FGSIS - Female Genital Self-Image Scale
Measured: 9-12 months
Secondary outcomes (14)
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
Measured: One month
Infection rate
The proportion of women with an infected wound until one month post-partum assessed by clinical examination and measured by REEDA scale
Measured: One month
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)
Measured: One month, three months, and 9-12 months
Dyspareunia
Measured by the PISQ-12 questionnaire which is a short form of the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12)
Measured: One month, three months, and 9-12months
Woman´s satisfaction with the aesthetic results of the perineal wound
Self-reported. The woman will be asked if she is satisfied with the aesthetic results of the perineal wound
Measured: One month, three months, and 9-12 months
Affected breastfeeding
The woman will be asked whether she is breastfeeding or not
Measured: One month, three months, and 9-12 months
Re-admission
The women will be asked whether they have been readmitted to the hospital and why within four weeks p.p.
Measured: Within one month
Prolapse
Measured by ICIQ-VS questionnaire which is a short form of the International Consultation on Incontinence Questionnaire - Vaginal Symptoms (ICIQ-VS)
Measured: One month, three months, and 9-12 months
Urinary incontinence
Measured by the ICIQ-UI SF questionnaire which is a short form of the International Consultation on Incontinence Questionnaire - Urinary Incontinence Short Form (ICIQ-UI SF)
Measured: One month, three months, and 9-12 months
Fecal incontinence
Measured by ICIQ-B questionnaire which is a short form of the International Consultation on Incontinence Questionnaire - Bowel (ICIQ-B)
Measured: One month, three months, and 9-12 months
Psychological well-being (maternal anxiety or depression)
Measured by Edinburgh Postnatal Depression Scale (EPDS). EPDS is a self-assessment questionnaire consisting of ten statements and the respondent is asked about their feelings over the last seven days. The answers are scored from 0-3 which gives an endpoint from 0-30. In Denmark, women are said to have depressive symptoms after delivery if they score 11 or higher
Measured: Three months, and 9-12 months
Pain intensity
Self-reported pain intensity measured by Visual Analog Scale (VAS-score). Numeric rating scale from 0-10 (0 = no pain - 10 = pain as bad as can be)
Measured: One month, three months, and 9-12 months
Consuming painkillers because of pain due to perineal tear
The participant will be asked whether she is consuming painkillers because of pain due to a perineal tear (Yes/No)
Measured: One month, three months, and 9-12 months
Pelvic floor muscle contraction
Measured by Modified Oxford scale
Measured: One month and 9-12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2023
- Study start15 Sep 2023
- Primary completion20 Aug 2026
- Study completion20 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dehiscence WoundStudies of the same condition, open and under way.
- 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
- 302 participants (actual)
Sponsor and investigators
- Lead sponsor
- Herlev Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hanna Jangö, Herlev Hospital
- Investigators
- Hanna M. Jangö, MD, PhD, Principal investigator, Copenhagen University Hospital - Herlev and Gentofte
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06026423
- Sponsor's protocol ID
- H-23022460
- Acronym
- HEAL
- Status last verified
- Sep 2026
- First submitted
- 30 Aug 2023
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dehisced Perineal Tear After Vaginal Labour (HEAL) - Conservative Treatment or Resuturing
- ClinicalTrials.gov ID
- NCT06026423
- Acronym / sponsor ID
- HEAL / H-23022460
- Keywords
- Dehiscence, Secondary Perineal Tear, Episiotomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 302 participants (actual)
- Lead sponsor
- Herlev HospitalUniversity, hospital or other
- Study start
- 15 Sep 2023 (actual)
- Primary completion
- 20 Aug 2026 (actual)
- Study completion
- 20 Aug 2026 (actual)
- First posted
- 7 Sep 2023 (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 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Normal/uncomplicated healing process | – | Other: Clinical examination and pictures, Other: Questionnaire100 women with a second-degree tear or episiotomy primarily sutured after labor: identified with a normal/uncomplicated healing process |
| Dehisced wound treated with secondary resuturing | – | Other: Clinical examination and pictures, Other: Questionnaire100 women with a second-degree tear or episiotomy: identified with a dehisced wound treated with secondary resuturing |
| Dehisced wound treated with conservative management | – | Other: Clinical examination and pictures, Other: Questionnaire100 women with a second-degree tear or episiotomy: identified with a dehisced wound treated with conservative management |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- None, first, third- and fourth-degree tear
- Cesarean Section
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 |
|---|---|---|
| Clinical examination and picturesA 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. | Other | Dehisced wound treated with conservative management, Dehisced wound treated with secondary resuturing, Normal/uncomplicated healing process |
| QuestionnaireThe 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. | Other | Dehisced wound treated with conservative management, Dehisced wound treated with secondary resuturing, Normal/uncomplicated healing process |
Primary outcome
Body image
Time frame: 9-12 months
Measured by the Body-Image questionnaire FGSIS - Female Genital Self-Image Scale
14 secondary outcomes
Wound healing
Time frame: One month
Infection rate
Time frame: One month
Resuming sexual intercourse
Time frame: One month, three months, and 9-12 months
Dyspareunia
Time frame: One month, three months, and 9-12months
Woman´s satisfaction with the aesthetic results of the perineal wound
Time frame: One month, three months, and 9-12 months
Affected breastfeeding
Time frame: One month, three months, and 9-12 months
Re-admission
Time frame: Within one month
Prolapse
Time frame: One month, three months, and 9-12 months
Urinary incontinence
Time frame: One month, three months, and 9-12 months
Fecal incontinence
Time frame: One month, three months, and 9-12 months
Psychological well-being (maternal anxiety or depression)
Time frame: Three months, and 9-12 months
Pain intensity
Time frame: One month, three months, and 9-12 months
Consuming painkillers because of pain due to perineal tear
Time frame: One month, three months, and 9-12 months
Pelvic floor muscle contraction
Time frame: One month and 9-12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Dehiscence Wound
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Not yet recruitingPhase 2
Early Feeding TL Trial
Total Laryngectomy
Not yet recruitingObservational study
Arterial Stiffness During Negative Pressure Wound Therapy for Abdominal Wall Wounds
Postoperative Abdominal Wall Wound Complications, Surgical Wound Infection
Not yet recruiting
Comparative Study of Regional Nerve Blocks in Primary Cleft Palate Repair
Cleft Lip, Cleft Palate +/- Lip
Not yet recruiting
Knotless Versus Conventional Sutures for Wound Closure in Cerebral Palsy Multilevel Surgery
Cerebral Palsy
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. This study is not recruiting at the moment.
Hanna M. Jangö, MD, PhD principal investigator
Copenhagen University Hospital - Herlev and Gentofte
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 Dehiscence Wound and Secondary Perineal Tear, run by Herlev Hospital at 1 site in Denmark.
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: finished, as of the sponsor's last update on 25 Sep 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 Denmark. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Body image (time frame: 9-12 months). 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 25 Sep 2026.