<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/NCT04446780</url>
  </required_header>
  <id_info>
    <org_study_id>INSTRUMODA</org_study_id>
    <nct_id>NCT04446780</nct_id>
  </id_info>
  <brief_title>Mediolateral Episiotomy and Obstetric Anal Sphincter Injuries in Instrumental Delivery</brief_title>
  <acronym>INSTRUMODA</acronym>
  <official_title>Mediolateral Episiotomy and Prevention of Obstetric Anal Sphincter Injuries in Instrumental Delivery: a Prospective Population-based Propensity Score Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Poitiers University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Poitiers University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Literature is contradictory about the impact of mediolateral episiotomy during operative&#xD;
      vaginal delivery in obstetric anal sphincter injuries prevention explaining the absence of&#xD;
      international guidelines. The investigators consider that a randomized trials does not&#xD;
      appears feasible for both ethical and practical reason and so we suggest a large national&#xD;
      observational study.&#xD;
&#xD;
      The investigators will include all nulliparous women that underwent an operative vaginal&#xD;
      delivery within the 72h following the delivery at more than 34 weeks of amenorrhea. The&#xD;
      investigators will collect data about the history of pregnancy, the course of labor, the mode&#xD;
      of delivery, maternal immediate and one-year morbidity, neonatal immediate morbidity. The&#xD;
      investigators expect a one-year study in 129 recruiting center with 15000 included women.&#xD;
&#xD;
      The primary objective is to assess the protective effect of mediolateral episiotomy against&#xD;
      obstetric anal sphincter injury during instrumental delivery in nulliparous women according&#xD;
      to the type of instrument used. The secondary endpoints are to investigate the effect of&#xD;
      mediolateral episiotomy on one-year maternal morbidity, immediate maternal morbidity. The&#xD;
      investigators also aim to develop a clinical score to assess the absolute risk of obstetric&#xD;
      anal sphincter injury during instrumental delivery. Finally, the investigators will&#xD;
      investigate the impact of fetal presentation ultrasound assessment immediately before&#xD;
      instrumental delivery on the mode of delivery.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">April 1, 2021</start_date>
  <completion_date type="Anticipated">April 2023</completion_date>
  <primary_completion_date type="Anticipated">April 1, 2022</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>Obstetric Anal Sphincter Injury (mediolateral episiotomy vs no episiotomy for each type of instrument)</measure>
    <time_frame>Immediately after the delivery</time_frame>
    <description>Perineal tears involving the anal sphincter complex (3rd and 4th degree according RCOG OMS classification)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Immediate maternal morbidity (mediolateral episiotomy vs no episiotomy)</measure>
    <time_frame>through mother's hospitalization, an average of 4 days</time_frame>
    <description>post partum hemorrhage, perineal infection, perineal hematoma, perineal pain, difficulty for voiding, satisfaction about childbirth, intensive care admission, death</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Immediate neonatal morbidity (mediolateral episiotomy versus no episiotomy)</measure>
    <time_frame>through mother's hospitalization, an average of 4 days</time_frame>
    <description>Clinical vitality status, neonatal cephalic marks , neonatal bone fractures, admission into intensive unit care, death</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>One year maternal morbidity (mediolateral episiotomy versus no episiotomy)</measure>
    <time_frame>1 year</time_frame>
    <description>Anal incontinence, urinary incontinence, perineal pain, postnatal depression, sexual function, self rated health</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Association between fetal presentation assessment before the delivery and the issue of delivery (ultrasound assessment versus no ultrasound assessment)</measure>
    <time_frame>through mother's hospitalization, an average of 4 days</time_frame>
    <description>Failed instrumental delivery defined as a requirement of several instrument and/or requirement of cesarean section</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Development of a clinical score to assess the absolute risk of obstetric anal sphincter injury during instrumental delivery (with or without mediolateral episiotomy)</measure>
    <time_frame>through mother's hospitalization, an average of 4 days</time_frame>
    <description>We will report the sensitivity, specificity and area under the curve of this score.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">15000</enrollment>
  <condition>Obstetric Anal Sphincter Injury</condition>
  <condition>Episiotomy Wound</condition>
  <condition>Anal Incontinence</condition>
  <condition>Pelvic Floor Disorders</condition>
  <condition>Depression</condition>
  <arm_group>
    <arm_group_label>Women who underwent an episiotomy</arm_group_label>
    <description>Nulliparous women who underwent an instrumental vaginal delivery with mediolateral episiotomy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Women who did not underwent an episiotomy</arm_group_label>
    <description>Nulliparous women who underwent an instrumental vaginal delivery without mediolateral episiotomy</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Mediolateral episiotomy</intervention_name>
    <description>Cutting of the perineum during vaginal delivery in order to avoid obstetric anal sphincter injury</description>
    <arm_group_label>Women who underwent an episiotomy</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        We will include in 121 centers in France during women year women who gave birth to their&#xD;
        first child with requirement of an operative delivery. We will compare those who underwent&#xD;
        a mediolateral episiotomy to those wo have not for the occurrence of obstetric anal&#xD;
        sphincter injury according to the type of instrument used&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age of 18 years or older&#xD;
&#xD;
          -  nulliparity and instrumental delivery of a singleton in cephalic presentation in the&#xD;
             previous 72 hours including failure of vaginal instrumental delivery leading to&#xD;
             cesarean section&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  expression of any opposition or objection to study participation&#xD;
&#xD;
          -  previous delivery of a fetus at a gestational age greater than 20 weeks, regardless of&#xD;
             the mode of delivery&#xD;
&#xD;
          -  preterm birth before 34 weeks of amenorrhea&#xD;
&#xD;
          -  fetal presentation other than cephalic&#xD;
&#xD;
          -  multiple pregnancy&#xD;
&#xD;
          -  in utero death&#xD;
&#xD;
          -  inability to understand French&#xD;
&#xD;
          -  under judicial protection&#xD;
&#xD;
          -  without access to a numeric terminal with internet connexion&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Bertrand GACHON, MD</last_name>
    <phone>+33549443945</phone>
    <email>bertrand.gachon@chu-poitiers.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Poitiers University Hospital</name>
      <address>
        <city>Poitiers</city>
        <zip>86000</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Bertrand GACHON</last_name>
      <phone>+33549443945</phone>
      <email>bertrand.gachon@chu-poitiers.fr</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>June 15, 2020</study_first_submitted>
  <study_first_submitted_qc>June 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 25, 2020</study_first_posted>
  <last_update_submitted>June 29, 2021</last_update_submitted>
  <last_update_submitted_qc>June 29, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 30, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fecal Incontinence</mesh_term>
    <mesh_term>Pelvic Floor Disorders</mesh_term>
    <mesh_term>Wounds and Injuries</mesh_term>
  </condition_browse>
  <!-- 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/NCT04446780
org study id: INSTRUMODA
nct id: NCT04446780
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Literature is contradictory about the impact of mediolateral episiotomy during operative
      vaginal delivery in obstetric anal sphincter injuries prevention explaining the absence of
      international guidelines. The investigators consider that a randomized trials does not
      appears feasible for both ethical and practical reason and so we suggest a large national
      observational study.

      The investigators will include all nulliparous women that underwent an operative vaginal
      delivery within the 72h following the delivery at more than 34 weeks of amenorrhea. The
      investigators will collect data about the history of pregnancy, the course of labor, the mode
      of delivery, maternal immediate and one-year morbidity, neonatal immediate morbidity. The
      investigators expect a one-year study in 129 recruiting center with 15000 included women.

      The primary objective is to assess the protective effect of mediolateral episiotomy against
      obstetric anal sphincter injury during instrumental delivery in nulliparous women according
      to the type of instrument used. The secondary endpoints are to investigate the effect of
      mediolateral episiotomy on one-year maternal morbidity, immediate maternal morbidity. The
      investigators also aim to develop a clinical score to assess the absolute risk of obstetric
      anal sphincter injury during instrumental delivery. Finally, the investigators will
      investigate the impact of fetal presentation ultrasound assessment immediately before
      instrumental delivery on the mode of delivery.
observational model: Cohort
time perspective: Prospective
measure: Obstetric Anal Sphincter Injury (mediolateral episiotomy vs no episiotomy for each type of instrument)
time frame: Immediately after the delivery
description: Perineal tears involving the anal sphincter complex (3rd and 4th degree according RCOG OMS classification)
measure: Immediate maternal morbidity (mediolateral episiotomy vs no episiotomy)
time frame: through mother's hospitalization, an average of 4 days
description: post partum hemorrhage, perineal infection, perineal hematoma, perineal pain, difficulty for voiding, satisfaction about childbirth, intensive care admission, death
measure: Immediate neonatal morbidity (mediolateral episiotomy versus no episiotomy)
time frame: through mother's hospitalization, an average of 4 days
description: Clinical vitality status, neonatal cephalic marks , neonatal bone fractures, admission into intensive unit care, death
measure: One year maternal morbidity (mediolateral episiotomy versus no episiotomy)
time frame: 1 year
description: Anal incontinence, urinary incontinence, perineal pain, postnatal depression, sexual function, self rated health
measure: Association between fetal presentation assessment before the delivery and the issue of delivery (ultrasound assessment versus no ultrasound assessment)
time frame: through mother's hospitalization, an average of 4 days
description: Failed instrumental delivery defined as a requirement of several instrument and/or requirement of cesarean section
measure: Development of a clinical score to assess the absolute risk of obstetric anal sphincter injury during instrumental delivery (with or without mediolateral episiotomy)
time frame: through mother's hospitalization, an average of 4 days
description: We will report the sensitivity, specificity and area under the curve of this score.
arm group label: Women who underwent an episiotomy
description: Nulliparous women who underwent an instrumental vaginal delivery with mediolateral episiotomy
arm group label: Women who did not underwent an episiotomy
description: Nulliparous women who underwent an instrumental vaginal delivery without mediolateral episiotomy
intervention type: Procedure
intervention name: Mediolateral episiotomy
description: Cutting of the perineum during vaginal delivery in order to avoid obstetric anal sphincter injury
arm group label: Women who underwent an episiotomy
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Bertrand GACHON, MD
phone: +33549443945
email: bertrand.gachon@chu-poitiers.fr
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Sponsor
mesh term: Fecal Incontinence
mesh term: Pelvic Floor Disorders
mesh term: Wounds and Injuries