<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/NCT03806348</url>
  </required_header>
  <id_info>
    <org_study_id>Paris2018</org_study_id>
    <nct_id>NCT03806348</nct_id>
  </id_info>
  <brief_title>Early Resuturing Versus Expectant Management Following Perineal Wound Dehiscence Among Women Who Had a Vaginal Delivery</brief_title>
  <official_title>Early Resuturing Versus Expectant Management Following Perineal Wound Dehiscence: a Randomised Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Stockholm South General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Stockholm South General Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Women who deliver their baby vaginally often suffer from a perineal wound. The wound is after&#xD;
      being sutured sometimes dehisced after days up to a few weeks and this study will investigate&#xD;
      whether it is better to resuture early or leave the rupture for secondary healing.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      140 women will be included in the trial, 70 women will be randomized to resuturing and 70&#xD;
      women will be randomized to expectant management. The investigators will follow the women&#xD;
      with clinical investigations after 2 and 4 weeks. After two weeks the healing will be&#xD;
      measured using the REEDA scale and the women will be asked whether they breastfeed or not.&#xD;
      The psychological wellbeing will be measured using the EPDS (Edinburgh Postnatal Depression&#xD;
      Scale).&#xD;
&#xD;
      After four weeks the above will be done again as well as collecting of the daily pain diary&#xD;
      that the women have filled in since being included in the trial.&#xD;
&#xD;
      After one year the women will be seen again and the investigators will do a clinical&#xD;
      investigation including ultrasound of the perineal body, measurement of the perineal body,&#xD;
      POP-Q ( Pelvic Organ Prolapse Quantification System) as well as multiple validated scales as&#xD;
      EPDS, FSFI ( Female Sexual Function Index), PFIQ (Pelvic Floor Impact Questionnaire) and PFDI&#xD;
      (Pelvic Floor Distress Inventory). These scales will help the investigators to find out if&#xD;
      the women have moderate to much trouble with vaginal wideness and/ or moderate to much&#xD;
      problems during defecation and therefore, if the perineal body is palpated smaller than 2 cm,&#xD;
      there will be indication for a perineal reconstruction.&#xD;
&#xD;
      The primary outcome will be to investigate whether early resuturing is reducing the need of a&#xD;
      later secondary reconstruction of the perineal body compared with conservative management&#xD;
      concerning dehisced perineal wounds.&#xD;
&#xD;
      The secondary outcomes will be to investigate whether early resuturing is reducing the risk&#xD;
      of having symptoms from the perineum and/or sexual problems one year after delivery.&#xD;
&#xD;
      The healing of the wound and the estimated pain will be compared between the two groups.&#xD;
&#xD;
      Certain questions concerning secondary fear of childbirth will also be asked and compared&#xD;
      between the two groups.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">December 12, 2018</start_date>
  <completion_date type="Anticipated">January 1, 2021</completion_date>
  <primary_completion_date type="Anticipated">January 1, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Need of late perineal reconstruction</measure>
    <time_frame>One year</time_frame>
    <description>Digital palpation of the perineal body and assessment of thickness. POP-Q score; nine points in the vagina are identified. The hymen is the reference point to which the other points are compared. The prolapsed organs are measured in centimeters to the hymen. The measurements are taken when the Valsalva maneuver is performed by the woman.&#xD;
Anovaginal distance using perineal ultrasound. Validated scales to identify specific symptoms from the perineum and to identify the feeling of vaginal wideness and the need for digital assistance during defecation.&#xD;
PFDI 20- short form-version of pelvic floor distress inventory FSFI - female sexual function index PFIQ - pelvic floor impact questionnaire</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pelvic floor symptoms and the impact on quality of life</measure>
    <time_frame>One year</time_frame>
    <description>The PFDI 20 is both a symptom inventory and a measure of the degree of bother and distress (quality-of-life) caused by pelvic floor symptoms. It includes 20 questions and 3 scales. The 3 scales include questions taken from the following widely used outcome measures: Urinary Distress Inventory - 6 questions, Pelvic Organ Prolapse Distress Inventory - 6 questions, and Colorectal-Anal Distress Inventory - 8 questions. Each of the 3 scales is scored from 0 (least distress) to 100 (greatest distress). The sum of the scores of these 3 scales serves as the overall summary score of the PFDI-20 and ranges from 0 - 300.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pelvic floor symptoms and the impact on quality of life</measure>
    <time_frame>One year</time_frame>
    <description>The PFIQ-7 is used to assess life impact in women with pelvic floor disorders. It consists of 3 scales of 7 questions each taken from the Urinary Impact Questionnaire, the Pelvic Organ Prolapse Impact Questionnaire, and the Colorectal-Anal Impact Questionnaire. The 3 scales are scored from 0 (least impact) to 100 (greatest impact) and an overall summary score (0 to 300).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sexual function</measure>
    <time_frame>One year</time_frame>
    <description>The FSFI comprises of a 19 item questionnaire focused on sexual functioning. There are six domains assessed. The subject is advised to consider each of the questions in the context of the last 4 weeks. The answer choices in the FSFI carry a number of points and are summed to obtain six domain scores and an overall score. For the latter here is a threshold at 26.55 which means that all values below are classed as indicating female sexual dysfunction (FSD).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Wound healing</measure>
    <time_frame>2 weeks</time_frame>
    <description>REEDA ( Redness, Oedema, Ecchymosis, Discharge, Approximation) scale contains five criteria namely redness, edema, ecchymosis, discharge, and approximation of the wound edges, each receiving a score between 0 and 3. Thus, the total score could range from 0 to 15, with lower scores representing better-wound healing.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Wound healing</measure>
    <time_frame>4 weeks</time_frame>
    <description>REEDA scale contains five criteria namely redness, edema, ecchymosis, discharge, and approximation of the wound edges, each receiving a score between 0 and 3. Thus, the total score could range from 0 to 15, with lower scores representing better-wound healing.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain intensity measure: NRS</measure>
    <time_frame>From randomization to 4 weeks after.</time_frame>
    <description>Self reported daily pain intensity. NRS ( numeric rating scale), each day is scored 0-10 ( 0= no pain, 10= pain as bad as can be).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Secondary fear of childbirth</measure>
    <time_frame>One year.</time_frame>
    <description>One question concerning fear of giving birth in the future will be asked: &quot;What kind of delivery method would you prefer if getting pregnant again in the future, vaginal delivery or planned c-section?&quot;. W-DEQ B (Wijma Delivery Expectancy Questionnaire) is a questionnaire measuring the fear of giving birth after delivering. The questionnaire consists of 33 questions, every question has a score from 1-6. The higher score, the higher is the fear of giving birth.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Affected breastfeeding</measure>
    <time_frame>2 weeks</time_frame>
    <description>The participant will be asked whether she breastfeeds or not.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Affected breastfeeding</measure>
    <time_frame>4 weeks</time_frame>
    <description>The participant will be asked whether she breastfeeds or not.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Psychological wellbeing</measure>
    <time_frame>4 weeks</time_frame>
    <description>EPDS- Edinburgh Postnatal Depression Scale . EPDS is a self assessment questionnaire consisting of ten statements and the respondent is asked about her feelings the last seven days. The answers are scored from 0-3 which gives an endpoint from 0-30. In Sweden women are said to have depressive symptoms after delivery if scoring 12 or higher.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Psychological wellbeing</measure>
    <time_frame>One year.</time_frame>
    <description>EPDS- Edinburgh Postnatal Depression Scale . EPDS is a self assessment questionnaire consisting of ten statements and the respondent is asked about her feelings the last seven days. The answers are scored from 0-3 which gives an endpoint from 0-30. In Sweden women are said to have depressive symptoms after delivery if scoring 12 or higher.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">140</enrollment>
  <condition>Wound; Perineal Rupture, Dehiscence</condition>
  <arm_group>
    <arm_group_label>Resuturing</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Early resuturing of perineal wound dehiscence. Antibiotics: Amoxicillin 500 mg, Clavulanic Acid 125 mg and Metronidazole 400 mg by mouth, every 8 hours, for at least 6 Days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Conservative treatment</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Antibiotics: Amoxicillin 500 mg, Clavulanic Acid 125 mg and Metronidazole 400 mg by mouth, every 8 hours, for at least 6 Days.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Resuturing</intervention_name>
    <description>Early reconstruction of the perineal body after wound dehiscence within two weeks of delivery.</description>
    <arm_group_label>Resuturing</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Woman over 18 years old who had a vaginal delivery and suffered from a perineal&#xD;
             rupture, grade 2 (spontaneous or episiotomy).&#xD;
&#xD;
          -  No longer than two weeks has passed since delivery.&#xD;
&#xD;
          -  The woman must be able to give informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Perineal rupture grade 3 and 4.&#xD;
&#xD;
          -  Woman suffering from connective tissue disease.&#xD;
&#xD;
          -  Ongoing treatment with oral cortisone or other immunosuppressive disease.&#xD;
&#xD;
          -  Diabetes treated with insulin.&#xD;
&#xD;
          -  Suspicion of occult damage of the anal sphincter.&#xD;
&#xD;
          -  Earlier surgery of the perineum.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marion Ek, PhD, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Obstetrics and Gynecology, Stockholm South General Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Anna Drca, MD</last_name>
    <phone>+46705618733</phone>
    <email>anna.lundmark-drca@sll.se</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Denise Golmann, MD</last_name>
    <phone>+46707478144</phone>
    <email>denise.golmann@sll.se</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Department of Obstetrics and Gynecology, Stockholm South General Hospital</name>
      <address>
        <city>Stockholm</city>
        <zip>11883</zip>
        <country>Sweden</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Anna Drca, MD</last_name>
      <phone>+46705618733</phone>
      <email>anna.lundmark-drca@sll.se</email>
    </contact>
    <contact_backup>
      <last_name>Denise Golmann, MD</last_name>
      <phone>+46707478144</phone>
      <email>denise.golmann@sll.se</email>
    </contact_backup>
    <investigator>
      <last_name>Marion Ek, PhD, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>November 29, 2018</study_first_submitted>
  <study_first_submitted_qc>January 15, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 16, 2019</study_first_posted>
  <last_update_submitted>January 15, 2019</last_update_submitted>
  <last_update_submitted_qc>January 15, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 16, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Stockholm South General Hospital</investigator_affiliation>
    <investigator_full_name>Marion Ek</investigator_full_name>
    <investigator_title>Senior Consultant</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Wounds and Injuries</mesh_term>
    <mesh_term>Rupture</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT03806348
org study id: Paris2018
nct id: NCT03806348
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Women who deliver their baby vaginally often suffer from a perineal wound. The wound is after
      being sutured sometimes dehisced after days up to a few weeks and this study will investigate
      whether it is better to resuture early or leave the rupture for secondary healing.
140 women will be included in the trial, 70 women will be randomized to resuturing and 70
      women will be randomized to expectant management. The investigators will follow the women
      with clinical investigations after 2 and 4 weeks. After two weeks the healing will be
      measured using the REEDA scale and the women will be asked whether they breastfeed or not.
      The psychological wellbeing will be measured using the EPDS (Edinburgh Postnatal Depression
      Scale).

      After four weeks the above will be done again as well as collecting of the daily pain diary
      that the women have filled in since being included in the trial.

      After one year the women will be seen again and the investigators will do a clinical
      investigation including ultrasound of the perineal body, measurement of the perineal body,
      POP-Q ( Pelvic Organ Prolapse Quantification System) as well as multiple validated scales as
      EPDS, FSFI ( Female Sexual Function Index), PFIQ (Pelvic Floor Impact Questionnaire) and PFDI
      (Pelvic Floor Distress Inventory). These scales will help the investigators to find out if
      the women have moderate to much trouble with vaginal wideness and/ or moderate to much
      problems during defecation and therefore, if the perineal body is palpated smaller than 2 cm,
      there will be indication for a perineal reconstruction.

      The primary outcome will be to investigate whether early resuturing is reducing the need of a
      later secondary reconstruction of the perineal body compared with conservative management
      concerning dehisced perineal wounds.

      The secondary outcomes will be to investigate whether early resuturing is reducing the risk
      of having symptoms from the perineum and/or sexual problems one year after delivery.

      The healing of the wound and the estimated pain will be compared between the two groups.

      Certain questions concerning secondary fear of childbirth will also be asked and compared
      between the two groups.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Need of late perineal reconstruction
time frame: One year
description: Digital palpation of the perineal body and assessment of thickness. POP-Q score; nine points in the vagina are identified. The hymen is the reference point to which the other points are compared. The prolapsed organs are measured in centimeters to the hymen. The measurements are taken when the Valsalva maneuver is performed by the woman.
Anovaginal distance using perineal ultrasound. Validated scales to identify specific symptoms from the perineum and to identify the feeling of vaginal wideness and the need for digital assistance during defecation.
PFDI 20- short form-version of pelvic floor distress inventory FSFI - female sexual function index PFIQ - pelvic floor impact questionnaire
measure: Pelvic floor symptoms and the impact on quality of life
time frame: One year
description: The PFDI 20 is both a symptom inventory and a measure of the degree of bother and distress (quality-of-life) caused by pelvic floor symptoms. It includes 20 questions and 3 scales. The 3 scales include questions taken from the following widely used outcome measures: Urinary Distress Inventory - 6 questions, Pelvic Organ Prolapse Distress Inventory - 6 questions, and Colorectal-Anal Distress Inventory - 8 questions. Each of the 3 scales is scored from 0 (least distress) to 100 (greatest distress). The sum of the scores of these 3 scales serves as the overall summary score of the PFDI-20 and ranges from 0 - 300.
measure: Pelvic floor symptoms and the impact on quality of life
time frame: One year
description: The PFIQ-7 is used to assess life impact in women with pelvic floor disorders. It consists of 3 scales of 7 questions each taken from the Urinary Impact Questionnaire, the Pelvic Organ Prolapse Impact Questionnaire, and the Colorectal-Anal Impact Questionnaire. The 3 scales are scored from 0 (least impact) to 100 (greatest impact) and an overall summary score (0 to 300).
measure: Sexual function
time frame: One year
description: The FSFI comprises of a 19 item questionnaire focused on sexual functioning. There are six domains assessed. The subject is advised to consider each of the questions in the context of the last 4 weeks. The answer choices in the FSFI carry a number of points and are summed to obtain six domain scores and an overall score. For the latter here is a threshold at 26.55 which means that all values below are classed as indicating female sexual dysfunction (FSD).
measure: Wound healing
time frame: 2 weeks
description: REEDA ( Redness, Oedema, Ecchymosis, Discharge, Approximation) scale contains five criteria namely redness, edema, ecchymosis, discharge, and approximation of the wound edges, each receiving a score between 0 and 3. Thus, the total score could range from 0 to 15, with lower scores representing better-wound healing.
measure: Wound healing
time frame: 4 weeks
description: REEDA scale contains five criteria namely redness, edema, ecchymosis, discharge, and approximation of the wound edges, each receiving a score between 0 and 3. Thus, the total score could range from 0 to 15, with lower scores representing better-wound healing.
measure: Pain intensity measure: NRS
time frame: From randomization to 4 weeks after.
description: Self reported daily pain intensity. NRS ( numeric rating scale), each day is scored 0-10 ( 0= no pain, 10= pain as bad as can be).
measure: Secondary fear of childbirth
time frame: One year.
description: One question concerning fear of giving birth in the future will be asked: "What kind of delivery method would you prefer if getting pregnant again in the future, vaginal delivery or planned c-section?". W-DEQ B (Wijma Delivery Expectancy Questionnaire) is a questionnaire measuring the fear of giving birth after delivering. The questionnaire consists of 33 questions, every question has a score from 1-6. The higher score, the higher is the fear of giving birth.
measure: Affected breastfeeding
time frame: 2 weeks
description: The participant will be asked whether she breastfeeds or not.
measure: Affected breastfeeding
time frame: 4 weeks
description: The participant will be asked whether she breastfeeds or not.
measure: Psychological wellbeing
time frame: 4 weeks
description: EPDS- Edinburgh Postnatal Depression Scale . EPDS is a self assessment questionnaire consisting of ten statements and the respondent is asked about her feelings the last seven days. The answers are scored from 0-3 which gives an endpoint from 0-30. In Sweden women are said to have depressive symptoms after delivery if scoring 12 or higher.
measure: Psychological wellbeing
time frame: One year.
description: EPDS- Edinburgh Postnatal Depression Scale . EPDS is a self assessment questionnaire consisting of ten statements and the respondent is asked about her feelings the last seven days. The answers are scored from 0-3 which gives an endpoint from 0-30. In Sweden women are said to have depressive symptoms after delivery if scoring 12 or higher.
arm group label: Resuturing
arm group type: Experimental
description: Early resuturing of perineal wound dehiscence. Antibiotics: Amoxicillin 500 mg, Clavulanic Acid 125 mg and Metronidazole 400 mg by mouth, every 8 hours, for at least 6 Days.
arm group label: Conservative treatment
arm group type: No Intervention
description: Antibiotics: Amoxicillin 500 mg, Clavulanic Acid 125 mg and Metronidazole 400 mg by mouth, every 8 hours, for at least 6 Days.
intervention type: Procedure
intervention name: Resuturing
description: Early reconstruction of the perineal body after wound dehiscence within two weeks of delivery.
arm group label: Resuturing
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Marion Ek, PhD, MD
role: Principal Investigator
affiliation: Department of Obstetrics and Gynecology, Stockholm South General Hospital
last name: Anna Drca, MD
phone: +46705618733
email: anna.lundmark-drca@sll.se
last name: Denise Golmann, MD
phone: +46707478144
email: denise.golmann@sll.se
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: Sweden
responsible party type: Principal Investigator
investigator affiliation: Stockholm South General Hospital
investigator full name: Marion Ek
investigator title: Senior Consultant
mesh term: Wounds and Injuries
mesh term: Rupture
sharing ipd: No