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NCT Number: NCT06026423

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

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

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Key information

Conditions

Dehiscence Wound Episiotomy; Dehiscence Secondary Perineal Tear

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Department of Obstetrics and Gynaecology, Copenhagen University Hospital - Herlev and Gentofte

Herlev, DK-2730, Denmark

Location status: Recruiting

Location contact

Hanna M. Jangö, MD, PhD, Associate Professor

CONTACT

[email protected]

+4538681612

Hanna M. Jangö, MD, PhD, Associate Professor

PRINCIPAL_INVESTIGATOR

Hanne K. Hegaard, Prof., Midwife, PhD

SUB_INVESTIGATOR

Lærke V. Moestrup, Midwife, MSc, PhD-student

SUB_INVESTIGATOR

Niels Klarskov, Prof., Chef Physician, DMSc

SUB_INVESTIGATOR

Thomas Bergholt, Prof., Chief Physician, PhD

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Clinical examination and pictures

Other

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.

Questionnaire

Other

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.

Primary outcomes

  1. Body image

    Time frame: 9-12 months

    Measured by the Body-Image questionnaire FGSIS - Female Genital Self-Image Scale

Secondary outcomes

  1. Wound healing

    Time frame: One month

    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

  2. Infection rate

    Time frame: One month

    The proportion of women with an infected wound until one month post-partum assessed by clinical examination and measured by REEDA scale

  3. Resuming sexual intercourse

    Time frame: One month, three months, and 9-12 months

    Measured by the PISQ-12 questionnaire which is a short form of the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12)

  4. Dyspareunia

    Time frame: One month, three months, and 9-12months

    Measured by the PISQ-12 questionnaire which is a short form of the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12)

  5. Woman´s satisfaction with the aesthetic results of the perineal wound

    Time frame: One month, three months, and 9-12 months

    Self-reported. The woman will be asked if she is satisfied with the aesthetic results of the perineal wound

  6. Affected breastfeeding

    Time frame: One month, three months, and 9-12 months

    The woman will be asked whether she is breastfeeding or not

  7. Re-admission

    Time frame: Within one month

    The women will be asked whether they have been readmitted to the hospital and why within four weeks p.p.

  8. Prolapse

    Time frame: One month, three months, and 9-12 months

    Measured by ICIQ-VS questionnaire which is a short form of the International Consultation on Incontinence Questionnaire - Vaginal Symptoms (ICIQ-VS)

  9. Urinary incontinence

    Time frame: One month, three months, and 9-12 months

    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)

  10. Fecal incontinence

    Time frame: One month, three months, and 9-12 months

    Measured by ICIQ-B questionnaire which is a short form of the International Consultation on Incontinence Questionnaire - Bowel (ICIQ-B)

  11. Psychological well-being (maternal anxiety or depression)

    Time frame: Three months, and 9-12 months

    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

  12. Pain intensity

    Time frame: One month, three months, and 9-12 months

    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)

  13. Consuming painkillers because of pain due to perineal tear

    Time frame: One month, three months, and 9-12 months

    The participant will be asked whether she is consuming painkillers because of pain due to a perineal tear (Yes/No)

  14. Pelvic floor muscle contraction

    Time frame: One month and 9-12 months

    Measured by Modified Oxford scale

Study contacts

Contact information is provided by the study sponsor or research team.

Hanna M. Jangö, MD, PhD

CONTACT

[email protected]

+45 38381612

Lærke V. Moestrup, PhD student

CONTACT

[email protected]

+45 21351767

Sponsors and collaborators

Lead sponsor

Herlev Hospital

Other

Registry information

Official study title

Dehisced Perineal Tear After Vaginal Labour (HEAL) - Conservative Treatment or Resuturing

Acronym: HEAL

Important dates

Study start
2023
Primary completion
2024
Study completion
2026
First posted
Sep 7, 2023
Registry last updated
Sep 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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