<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/NCT03287258</url>
  </required_header>
  <id_info>
    <org_study_id>perineal preparation study</org_study_id>
    <nct_id>NCT03287258</nct_id>
  </id_info>
  <brief_title>Perineal Preparation for Pregnant Ladies.</brief_title>
  <official_title>Digital Perineal Massage and Pelvic Floor Muscle Exercise as an Antenatal Program for Prevention of Perineal Trauma in Elderly Women, a Randomized Controlled Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kasr El Aini Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kasr El Aini 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>
      Pregnant participants will be recruited at the obstetrics outpatient clinic during their&#xD;
      visits 4 weeks before the due date. They are randomized into two groups. The first group will&#xD;
      be educated to do digital perineal massage. They will be also educated to do pelvic floor&#xD;
      muscle exercises and will receive the usual education program for strengthening the pelvic&#xD;
      floor. The second group will receive the usual education program for strengthening the pelvic&#xD;
      floor. Occurrence of perineal laceration will be reported at time of delivery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Pregnant participants will be recruited at the obstetrics outpatient clinic during their&#xD;
      visits 4 weeks before the due date. They are randomized into two groups. The first group will&#xD;
      be educated to do digital perineal massage. They will be also educated to do pelvic floor&#xD;
      muscle exercises and will receive the usual educational pelvic floor dysfunction prevention&#xD;
      program for strengthening the pelvic floor. The second group will receive the usual education&#xD;
      program for strengthening the pelvic floor. Occurrence of perineal laceration will be&#xD;
      reported at time of delivery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 25, 2017</start_date>
  <completion_date type="Actual">December 31, 2017</completion_date>
  <primary_completion_date type="Actual">July 20, 2017</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>Prevention</primary_purpose>
    <masking>Triple (Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>perineal tears Proportion of perineal tears will be assessed by an investigator who will attend the participant delivery</measure>
    <time_frame>At 15 minutes from delivery</time_frame>
    <description>Proportion of participants who have perineal tears</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>episiotomy need Proportion of participants who need episiotomy at time of delivery will be assessed by an investigator</measure>
    <time_frame>At 15 minutes from delivery</time_frame>
    <description>Proportion of participants who need episiotomy at time of delivery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of the second stage of labour</measure>
    <time_frame>2 hours</time_frame>
    <description>Duration of the second stage of labour will be assessed by an investigator</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">400</enrollment>
  <condition>Delivery; Trauma</condition>
  <condition>Pelvic Floor; Perineal Rupture, Obstetric</condition>
  <condition>Pelvic Floor Muscle Weakness</condition>
  <arm_group>
    <arm_group_label>three program</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>200 patients are subjected to educational Pelvic floor dysfunction prevention program with perineal massage and Pelvic floor muscle exercise.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>one program</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>200 patients are subjected to educational Pelvic floor dysfunction prevention program</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>3 program</intervention_name>
    <description>The participants will receive 3 programs.The educational pelvic floor dysfunction prevention program, pelvic floor muscle exercise program and perineal massage program will be educated by an investigator during the participant visit 4 weeks before her due date</description>
    <arm_group_label>three program</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>one program</intervention_name>
    <description>The participants will receive one program. That is the educational pelvic floor dysfunction prevention program.The instructions of the program will be given by an investigator once during the participant visit 4 weeks before her due date.</description>
    <arm_group_label>one program</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pregnant women ≥ 35 years old&#xD;
&#xD;
          -  Primigravida or multi gravida&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of chronic constipation&#xD;
&#xD;
          -  History of chronic cough&#xD;
&#xD;
          -  Current or past urinary or anal incontinence&#xD;
&#xD;
          -  History of genital prolapse before pregnancy&#xD;
&#xD;
          -  History of neuromuscular disorders or connective tissue disorders&#xD;
&#xD;
          -  History of medical disorders&#xD;
&#xD;
          -  History of preterm or precipitate labour&#xD;
&#xD;
          -  History of premature preterm rupture of membranes.&#xD;
&#xD;
          -  Genital infections&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>35 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Amira Dieb, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>KasrAlainiH</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>KasralainiH</name>
      <address>
        <city>Cairo</city>
        <zip>11956</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>July 22, 2017</study_first_submitted>
  <study_first_submitted_qc>September 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 19, 2017</study_first_posted>
  <last_update_submitted>October 31, 2018</last_update_submitted>
  <last_update_submitted_qc>October 31, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 2, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Kasr El Aini Hospital</investigator_affiliation>
    <investigator_full_name>Amira S Dieb</investigator_full_name>
    <investigator_title>Department of Obstetrics and Gynecology, Kasr Al-Ainy hospital</investigator_title>
  </responsible_party>
  <keyword>perineal massage</keyword>
  <keyword>health education</keyword>
  <keyword>perineal tear</keyword>
  <keyword>episiotomy</keyword>
  <keyword>pelvic floor muscle exercise</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Muscle Weakness</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/NCT03287258
org study id: perineal preparation study
nct id: NCT03287258
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Pregnant participants will be recruited at the obstetrics outpatient clinic during their
      visits 4 weeks before the due date. They are randomized into two groups. The first group will
      be educated to do digital perineal massage. They will be also educated to do pelvic floor
      muscle exercises and will receive the usual education program for strengthening the pelvic
      floor. The second group will receive the usual education program for strengthening the pelvic
      floor. Occurrence of perineal laceration will be reported at time of delivery.
Pregnant participants will be recruited at the obstetrics outpatient clinic during their
      visits 4 weeks before the due date. They are randomized into two groups. The first group will
      be educated to do digital perineal massage. They will be also educated to do pelvic floor
      muscle exercises and will receive the usual educational pelvic floor dysfunction prevention
      program for strengthening the pelvic floor. The second group will receive the usual education
      program for strengthening the pelvic floor. Occurrence of perineal laceration will be
      reported at time of delivery.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Triple (Care Provider, Investigator, Outcomes Assessor)
measure: perineal tears Proportion of perineal tears will be assessed by an investigator who will attend the participant delivery
time frame: At 15 minutes from delivery
description: Proportion of participants who have perineal tears
measure: episiotomy need Proportion of participants who need episiotomy at time of delivery will be assessed by an investigator
time frame: At 15 minutes from delivery
description: Proportion of participants who need episiotomy at time of delivery
measure: Duration of the second stage of labour
time frame: 2 hours
description: Duration of the second stage of labour will be assessed by an investigator
arm group label: three program
arm group type: Active Comparator
description: 200 patients are subjected to educational Pelvic floor dysfunction prevention program with perineal massage and Pelvic floor muscle exercise.
arm group label: one program
arm group type: Active Comparator
description: 200 patients are subjected to educational Pelvic floor dysfunction prevention program
intervention type: Other
intervention name: 3 program
description: The participants will receive 3 programs.The educational pelvic floor dysfunction prevention program, pelvic floor muscle exercise program and perineal massage program will be educated by an investigator during the participant visit 4 weeks before her due date
arm group label: three program
intervention type: Other
intervention name: one program
description: The participants will receive one program. That is the educational pelvic floor dysfunction prevention program.The instructions of the program will be given by an investigator once during the participant visit 4 weeks before her due date.
arm group label: one program
criteria: 
gender: Female
minimum age: 35 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Amira Dieb, MD
role: Principal Investigator
affiliation: KasrAlainiH
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Kasr El Aini Hospital
investigator full name: Amira S Dieb
investigator title: Department of Obstetrics and Gynecology, Kasr Al-Ainy hospital
mesh term: Muscle Weakness
mesh term: Rupture
sharing ipd: No