xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06026423</url>
    </required_header>
    <id_info>
      <org_study_id>H-23022460</org_study_id>
      <nct_id>NCT06026423</nct_id>
    </id_info>
    <brief_title>Conservative Treatment or Resuturing Among Women With Perineal Wound Dehiscence After Vaginal Labour</brief_title>
    <acronym>HEAL</acronym>
    <official_title>Dehisced Perineal Tear After Vaginal Labour (HEAL) - Conservative Treatment or Resuturing</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Herlev Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Herlev Hospital</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this observational study is to make us more aware of the short and long-term&#xD;
        outcomes for women having an uncomplicated healing process after a rupture or birth cut in&#xD;
        the perineum after giving birth in relation to a healing process with a dehisced wound&#xD;
        treated with conservative management or secondary suturing.&#xD;
  &#xD;
        Participants will be asked to do&#xD;
  &#xD;
          -  A gynecological examination at one month after birth and 9-12 months after birth.&#xD;
  &#xD;
          -  Have a picture taken of the healing process&#xD;
  &#xD;
          -  Answer a questionnaire at one month, three months, and 9-12 months after birth&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The best way to manage perineal wound dehiscence after childbirth is unknown. Currently,&#xD;
        there is no agreed best practice recommendation for managing perineal wound dehiscence due to&#xD;
        a lack of evidence comparing conservative management with secondary suturing. Therefore,&#xD;
        studies are urgently needed to compare the benefits and risks of both treatments. This study&#xD;
        has the potential to significantly impact women´s health for those suffering from perineal&#xD;
        wound dehiscence.&#xD;
  &#xD;
        The investigators want to include 100 women who have had a primary repair of a second-degree&#xD;
        tear or episiotomy with a normal/uncomplicated healing process, 100 women with a&#xD;
        second-degree tear or episiotomy identified with a dehisced wound treated with secondary&#xD;
        resuturing, and 100 women with a second-degree tear or episiotomy identified with a dehisced&#xD;
        wound treated with conservative management.&#xD;
  &#xD;
        All women who meet the inclusion criteria are recommended the same treatment and follow-up as&#xD;
        currently present as standard care at the four hospitals that the investigators are&#xD;
        recruiting from. The study deviates from the standard of care by offering two extra clinical&#xD;
        examinations, one questionnaire evaluation without clinical examination, and a follow-up with&#xD;
        pictures of the perineal tear healing process.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">September 15, 2023</start_date>
    <completion_date type="Anticipated">September 1, 2026</completion_date>
    <primary_completion_date type="Anticipated">September 1, 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Body image</measure>
      <time_frame>9-12 months</time_frame>
      <description>Measured by the Body-Image questionnaire FGSIS - Female Genital Self-Image Scale</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Wound healing</measure>
      <time_frame>One month</time_frame>
      <description>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</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Infection rate</measure>
      <time_frame>One month</time_frame>
      <description>The proportion of women with an infected wound until one month post-partum assessed by clinical examination and measured by REEDA scale</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Resuming sexual intercourse</measure>
      <time_frame>One month, three months, and 9-12 months</time_frame>
      <description>Measured by the PISQ-12 questionnaire which is a short form of the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Dyspareunia</measure>
      <time_frame>One month, three months, and 9-12months</time_frame>
      <description>Measured by the PISQ-12 questionnaire which is a short form of the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Woman´s satisfaction with the aesthetic results of the perineal wound</measure>
      <time_frame>One month, three months, and 9-12 months</time_frame>
      <description>Self-reported. The woman will be asked if she is satisfied with the aesthetic results of the perineal wound</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Affected breastfeeding</measure>
      <time_frame>One month, three months, and 9-12 months</time_frame>
      <description>The woman will be asked whether she is breastfeeding or not</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Re-admission</measure>
      <time_frame>Within one month</time_frame>
      <description>The women will be asked whether they have been readmitted to the hospital and why within four weeks p.p.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Prolapse</measure>
      <time_frame>One month, three months, and 9-12 months</time_frame>
      <description>Measured by ICIQ-VS questionnaire which is a short form of the International Consultation on Incontinence Questionnaire - Vaginal Symptoms (ICIQ-VS)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Urinary incontinence</measure>
      <time_frame>One month, three months, and 9-12 months</time_frame>
      <description>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)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Fecal incontinence</measure>
      <time_frame>One month, three months, and 9-12 months</time_frame>
      <description>Measured by ICIQ-B questionnaire which is a short form of the International Consultation on Incontinence Questionnaire - Bowel (ICIQ-B)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Psychological well-being (maternal anxiety or depression)</measure>
      <time_frame>Three months, and 9-12 months</time_frame>
      <description>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</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pain intensity</measure>
      <time_frame>One month, three months, and 9-12 months</time_frame>
      <description>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)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Consuming painkillers because of pain due to perineal tear</measure>
      <time_frame>One month, three months, and 9-12 months</time_frame>
      <description>The participant will be asked whether she is consuming painkillers because of pain due to a perineal tear (Yes/No)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pelvic floor muscle contraction</measure>
      <time_frame>One month and 9-12 months</time_frame>
      <description>Measured by Modified Oxford scale</description>
    </secondary_outcome>
    <number_of_groups>3</number_of_groups>
    <enrollment type="Anticipated">300</enrollment>
    <condition>Dehiscence Wound</condition>
    <condition>Secondary Perineal Tear</condition>
    <condition>Episiotomy; Dehiscence</condition>
    <arm_group>
      <arm_group_label>Normal/uncomplicated healing process</arm_group_label>
      <description>100 women with a second-degree tear or episiotomy primarily sutured after labor: identified with a normal/uncomplicated healing process</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Dehisced wound treated with secondary resuturing</arm_group_label>
      <description>100 women with a second-degree tear or episiotomy: identified with a dehisced wound treated with secondary resuturing</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Dehisced wound treated with conservative management</arm_group_label>
      <description>100 women with a second-degree tear or episiotomy: identified with a dehisced wound treated with conservative management</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Clinical examination and pictures</intervention_name>
      <description>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.</description>
      <arm_group_label>Dehisced wound treated with conservative management</arm_group_label>
      <arm_group_label>Dehisced wound treated with secondary resuturing</arm_group_label>
      <arm_group_label>Normal/uncomplicated healing process</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Questionnaire</intervention_name>
      <description>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.</description>
      <arm_group_label>Dehisced wound treated with conservative management</arm_group_label>
      <arm_group_label>Dehisced wound treated with secondary resuturing</arm_group_label>
      <arm_group_label>Normal/uncomplicated healing process</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          We want to include 100 women who have had a primary repair of a second-degree tear or&#xD;
          episiotomy with an uncomplicated healing process. They will only be recruited from the&#xD;
          Perineal Care Clinics at the Department of Obstetrics and Gynecology at the Copenhagen&#xD;
          University Hospital - Herlev. Furthermore, we want to include 100 women with a&#xD;
          second-degree tear or episiotomy identified with a dehisced wound treated with secondary&#xD;
          resuturing, and 100 women with a second-degree tear or episiotomy identified with a&#xD;
          dehisced wound treated with conservative management. They will be recruited from the&#xD;
          Perineal Care Clinics at the Department of Obstetrics and Gynecology at the Copenhagen&#xD;
          University Hospitals - Rigshospitalet, Herlev Hospital, North Zealand Hospital, and&#xD;
          Hvidovre Hospital. The women will come for a clinical examination to assess wound infection&#xD;
          and healing 4 - 14 days post-partum.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Women with a vaginal delivery who have had a primary repair of a second-degree&#xD;
               perineal tear or episiotomy&#xD;
  &#xD;
            -  At least 18 years old&#xD;
  &#xD;
            -  Able to understand, read and speak Danish or English&#xD;
  &#xD;
            -  Able to give informed consent&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  None, first, third- and fourth-degree tear&#xD;
  &#xD;
            -  Cesarean Section&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Hanna M. Jangö, MD, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Copenhagen University Hospital - Herlev and Gentofte</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Lærke V. Moestrup, PhD student</last_name>
      <phone>+45 21351767</phone>
      <email>laerke.vinberg.moestrup@regionh.dk</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Hanna M. Jangö, MD, PhD</last_name>
      <phone>+45 38381612</phone>
      <email>hanna.margareta.jangoe@regionh.dk</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Department of Obstetrics and Gynaecology, Copenhagen University Hospital - Herlev and Gentofte</name>
        <address>
          <city>Herlev</city>
          <zip>DK-2730</zip>
          <country>Denmark</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Hanna M. Jangö, MD, PhD, Associate Professor</last_name>
        <phone>+4538681612</phone>
        <email>hanna.jango@regionh.dk</email>
      </contact>
      <investigator>
        <last_name>Hanna M. Jangö, MD, PhD, Associate Professor</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Lærke V. Moestrup, Midwife, MSc, PhD-student</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Thomas Bergholt, Prof., Chief Physician, PhD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Hanne K. Hegaard, Prof., Midwife, PhD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Niels Klarskov, Prof., Chef Physician, DMSc</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Denmark</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 30, 2023</study_first_submitted>
    <study_first_submitted_qc>August 30, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 7, 2023</study_first_posted>
    <last_update_submitted>September 15, 2023</last_update_submitted>
    <last_update_submitted_qc>September 15, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Herlev Hospital</investigator_affiliation>
      <investigator_full_name>Hanna Jangö</investigator_full_name>
      <investigator_title>Staff specialist, Ph.D., Associated professor</investigator_title>
    </responsible_party>
    <keyword>Dehiscence</keyword>
    <keyword>Secondary Perineal Tear</keyword>
    <keyword>Episiotomy</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Neoplasm Metastasis</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06026423
  org study id: H-23022460
  nct id: NCT06026423
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  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
  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.
  observational model: Cohort
  time perspective: Prospective
  measure: Body image
  time frame: 9-12 months
  description: Measured by the Body-Image questionnaire FGSIS - Female Genital Self-Image Scale
  measure: Wound healing
  time frame: One month
  description: 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
  measure: Infection rate
  time frame: One month
  description: The proportion of women with an infected wound until one month post-partum assessed by clinical examination and measured by REEDA scale
  measure: Resuming sexual intercourse
  time frame: One month, three months, and 9-12 months
  description: Measured by the PISQ-12 questionnaire which is a short form of the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12)
  measure: Dyspareunia
  time frame: One month, three months, and 9-12months
  description: Measured by the PISQ-12 questionnaire which is a short form of the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12)
  measure: Woman´s satisfaction with the aesthetic results of the perineal wound
  time frame: One month, three months, and 9-12 months
  description: Self-reported. The woman will be asked if she is satisfied with the aesthetic results of the perineal wound
  measure: Affected breastfeeding
  time frame: One month, three months, and 9-12 months
  description: The woman will be asked whether she is breastfeeding or not
  measure: Re-admission
  time frame: Within one month
  description: The women will be asked whether they have been readmitted to the hospital and why within four weeks p.p.
  measure: Prolapse
  time frame: One month, three months, and 9-12 months
  description: Measured by ICIQ-VS questionnaire which is a short form of the International Consultation on Incontinence Questionnaire - Vaginal Symptoms (ICIQ-VS)
  measure: Urinary incontinence
  time frame: One month, three months, and 9-12 months
  description: 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)
  measure: Fecal incontinence
  time frame: One month, three months, and 9-12 months
  description: Measured by ICIQ-B questionnaire which is a short form of the International Consultation on Incontinence Questionnaire - Bowel (ICIQ-B)
  measure: Psychological well-being (maternal anxiety or depression)
  time frame: Three months, and 9-12 months
  description: 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
  measure: Pain intensity
  time frame: One month, three months, and 9-12 months
  description: 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)
  measure: Consuming painkillers because of pain due to perineal tear
  time frame: One month, three months, and 9-12 months
  description: The participant will be asked whether she is consuming painkillers because of pain due to a perineal tear (Yes/No)
  measure: Pelvic floor muscle contraction
  time frame: One month and 9-12 months
  description: Measured by Modified Oxford scale
  arm group label: 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
  arm group label: 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
  arm group label: 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
  intervention type: Other
  intervention name: Clinical examination and pictures
  description: 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.
  arm group label: Dehisced wound treated with conservative management
  arm group label: Dehisced wound treated with secondary resuturing
  arm group label: Normal/uncomplicated healing process
  intervention type: Other
  intervention name: Questionnaire
  description: 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.
  arm group label: Dehisced wound treated with conservative management
  arm group label: Dehisced wound treated with secondary resuturing
  arm group label: Normal/uncomplicated healing process
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: Female
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Hanna M. Jangö, MD, PhD
  role: Principal Investigator
  affiliation: Copenhagen University Hospital - Herlev and Gentofte
  last name: Lærke V. Moestrup, PhD student
  phone: +45 21351767
  email: laerke.vinberg.moestrup@regionh.dk
  last name: Hanna M. Jangö, MD, PhD
  phone: +45 38381612
  email: hanna.margareta.jangoe@regionh.dk
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  country: Denmark
  responsible party type: Principal Investigator
  investigator affiliation: Herlev Hospital
  investigator full name: Hanna Jangö
  investigator title: Staff specialist, Ph.D., Associated professor
  mesh term: Neoplasm Metastasis
  sharing ipd: Undecided