<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/NCT03021954</url>
  </required_header>
  <id_info>
    <org_study_id>DCiptoMGHFMoegni</org_study_id>
    <nct_id>NCT03021954</nct_id>
  </id_info>
  <brief_title>The Role of Platelet Rich Plasma Towards the Repair of Pelvic Floor Muscle Damage in Primipara</brief_title>
  <official_title>The Role of Platelet Rich Plasma Towards the Repair of Pelvic Floor Muscle Damage in Primipara</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dr Cipto Mangunkusumo General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Indonesia University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Dr Cipto Mangunkusumo General Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims to see if platelet rich plasma (PRP) have beneficial effect on the repair of&#xD;
      pelvic floor muscle damage in primipara. Therefore, this double blinded randomized clinical&#xD;
      trial compares the pelvic floor muscle repair in primipara following labor between the&#xD;
      interventional group who received intramuscular PRP injection in levator ani muscle and the&#xD;
      control group, as assessed by ultrasonography, perineometry, and biomarker assessments.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study aims to see if platelet rich plasma (PRP) has beneficial effect on the repair of&#xD;
      pelvic floor muscle damage in primipara. Therefore, this double blinded randomized clinical&#xD;
      trial compares the pelvic floor muscle repair in primipara following labor between the&#xD;
      interventional group who received intramuscular PRP injection in levator ani muscle and the&#xD;
      control group, as assessed by ultrasonography, perineometry, and biomarker assessments. The&#xD;
      ultrasonography outcome measures include lower hiatal area during contraction and during&#xD;
      valsava. Menawhile, the biomarker assessments include Creatine Kinae, MyoD, and IGF-1. The&#xD;
      assessments are performed at multiple time points, which are before labor, 24-48 hours post&#xD;
      labor, 7 days post labor, 40 days post labor and 3 months post labor.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>November 2016</start_date>
  <completion_date type="Anticipated">December 2017</completion_date>
  <primary_completion_date type="Anticipated">September 2017</primary_completion_date>
  <phase>Phase 2/Phase 3</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 (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline (third trimester) lower hiatal area during contraction measured using pelvic floor USG at 7 days post partum</measure>
    <time_frame>Third trimester and 7 days post partum</time_frame>
    <description>Assessed using pelvic floor USG</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline (third trimester) lower hiatal area during contraction measured using pelvic floor USG at 40 days post partum</measure>
    <time_frame>Third trimester and 40 days post partum</time_frame>
    <description>Assessed using pelvic floor USG</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline (third trimester) lower hiatal area during contraction measured using pelvic floor USG at 3 months post partum</measure>
    <time_frame>Third trimester and 3 months post partum</time_frame>
    <description>Assessed using pelvic floor USG</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline (third trimester) lower hiatal area measured using pelvic floor USG during valsava at 7 days post partum</measure>
    <time_frame>Third trimester and 7 days post partum</time_frame>
    <description>Assessed using pelvic floor USG</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline (third trimester) lower hiatal area during valsava measured using pelvic floor USG at 40 days post partum</measure>
    <time_frame>Third trimester and 40 days post partum</time_frame>
    <description>Assessed using pelvic floor USG</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline (third trimester) lower hiatal area during valsava measured using pelvic floor USG at 3 months post partum</measure>
    <time_frame>Third trimester and 3 months post partum</time_frame>
    <description>Assessed using pelvic floor USG</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pelvic Floor Muscle Contraction</measure>
    <time_frame>Third trimester and 7 days post partum</time_frame>
    <description>assessed using perineometry</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pelvic Floor Muscle Contraction</measure>
    <time_frame>Third trimester and 40 days post partum</time_frame>
    <description>assessed using perineometry</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pelvic Floor Muscle Contraction</measure>
    <time_frame>Third trimester and 3 months post partum</time_frame>
    <description>assessed using perineometry</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Creatine Kinase</measure>
    <time_frame>before labor, 24-48 hour post partum, and 7 days post partum</time_frame>
    <description>Assessed using appropriate reagent</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>IGF-1</measure>
    <time_frame>before labor, 24-48 hour post partum</time_frame>
    <description>Assessed using ELISA</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>myoD</measure>
    <time_frame>7 days post partum</time_frame>
    <description>Assessed using ELISA</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain</measure>
    <time_frame>before labor, 7 days post partum, 40 days post partum, and 3 months post partum</time_frame>
    <description>assessed using VAS</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">90</enrollment>
  <condition>Pelvic Floor Disorders</condition>
  <arm_group>
    <arm_group_label>Platelet rich plasma</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Platelet rich plasma injected intramuscularly in pelvic floor muscle immediately following labor and before perineoraphy, simultaneously with the injection of local anesthesia</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No intervention given, patient will only get local anesthesia injection before perineoraphy</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Platelet Rich Plasma</intervention_name>
    <description>Platelet rich plasma is produced by obtaining patient's whole blood and processed by centrifugation and activation by CaCl2.</description>
    <arm_group_label>Platelet rich plasma</arm_group_label>
    <other_name>PRP</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  primigravida, in third trimester pregnancy&#xD;
&#xD;
          -  plan to do vaginal birth&#xD;
&#xD;
          -  consent to participate in this study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  history of pelvic floor disorder before pregnancy&#xD;
&#xD;
          -  history of pelvic surgery&#xD;
&#xD;
          -  avulsion of levator ani muscle (seen in USG)&#xD;
&#xD;
          -  unstable hemodynamic&#xD;
&#xD;
          -  trombocytopenia (&lt; 150,000)&#xD;
&#xD;
          -  anemia (Hb&lt; 10)&#xD;
&#xD;
          -  sepsis&#xD;
&#xD;
          -  infection on perineum&#xD;
&#xD;
          -  corticosteroid intake within last 2 weeks&#xD;
&#xD;
          -  smoking&#xD;
&#xD;
          -  hematopoetic or bone cancer&#xD;
&#xD;
          -  delivery by c-section&#xD;
&#xD;
          -  no perineoraphy after birth&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Fernandi Moegni, MD,OBGYN(C)</last_name>
    <role>Principal Investigator</role>
    <affiliation>FKUI/RSCM</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Fernandi Moegni, MD,OBGYN(C)</last_name>
    <phone>+6282298111778</phone>
    <email>fmoegni@yahoo.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Primary Care Centre</name>
      <address>
        <city>Jakarta Pusat</city>
        <state>DKI Jakarta</state>
        <country>Indonesia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Fernandi Moegni</last_name>
      <phone>+6282298111778</phone>
      <email>fmoegni@yahoo.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Indonesia</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 11, 2017</study_first_submitted>
  <study_first_submitted_qc>January 12, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 16, 2017</study_first_posted>
  <last_update_submitted>January 12, 2017</last_update_submitted>
  <last_update_submitted_qc>January 12, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 16, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Dr Cipto Mangunkusumo General Hospital</investigator_affiliation>
    <investigator_full_name>Fernandi Moegni</investigator_full_name>
    <investigator_title>M.D., SpOG(K)</investigator_title>
  </responsible_party>
  <keyword>platelet rich plasma</keyword>
  <keyword>pelvic floor disorders</keyword>
  <keyword>primipara</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pelvic Floor Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>March 22, 2022</submitted>
    <returned>July 21, 2022</returned>
    <submitted>July 25, 2022</submitted>
    <returned>June 29, 2023</returned>
    <submitted>July 6, 2023</submitted>
  </pending_results>
  <!-- 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/NCT03021954
org study id: DCiptoMGHFMoegni
nct id: NCT03021954
lead sponsor: 
collaborator: 
has dmc: Yes
This study aims to see if platelet rich plasma (PRP) have beneficial effect on the repair of
      pelvic floor muscle damage in primipara. Therefore, this double blinded randomized clinical
      trial compares the pelvic floor muscle repair in primipara following labor between the
      interventional group who received intramuscular PRP injection in levator ani muscle and the
      control group, as assessed by ultrasonography, perineometry, and biomarker assessments.
This study aims to see if platelet rich plasma (PRP) has beneficial effect on the repair of
      pelvic floor muscle damage in primipara. Therefore, this double blinded randomized clinical
      trial compares the pelvic floor muscle repair in primipara following labor between the
      interventional group who received intramuscular PRP injection in levator ani muscle and the
      control group, as assessed by ultrasonography, perineometry, and biomarker assessments. The
      ultrasonography outcome measures include lower hiatal area during contraction and during
      valsava. Menawhile, the biomarker assessments include Creatine Kinae, MyoD, and IGF-1. The
      assessments are performed at multiple time points, which are before labor, 24-48 hours post
      labor, 7 days post labor, 40 days post labor and 3 months post labor.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Change from baseline (third trimester) lower hiatal area during contraction measured using pelvic floor USG at 7 days post partum
time frame: Third trimester and 7 days post partum
description: Assessed using pelvic floor USG
measure: Change from baseline (third trimester) lower hiatal area during contraction measured using pelvic floor USG at 40 days post partum
time frame: Third trimester and 40 days post partum
description: Assessed using pelvic floor USG
measure: Change from baseline (third trimester) lower hiatal area during contraction measured using pelvic floor USG at 3 months post partum
time frame: Third trimester and 3 months post partum
description: Assessed using pelvic floor USG
measure: Change from baseline (third trimester) lower hiatal area measured using pelvic floor USG during valsava at 7 days post partum
time frame: Third trimester and 7 days post partum
description: Assessed using pelvic floor USG
measure: Change from baseline (third trimester) lower hiatal area during valsava measured using pelvic floor USG at 40 days post partum
time frame: Third trimester and 40 days post partum
description: Assessed using pelvic floor USG
measure: Change from baseline (third trimester) lower hiatal area during valsava measured using pelvic floor USG at 3 months post partum
time frame: Third trimester and 3 months post partum
description: Assessed using pelvic floor USG
measure: Pelvic Floor Muscle Contraction
time frame: Third trimester and 7 days post partum
description: assessed using perineometry
measure: Pelvic Floor Muscle Contraction
time frame: Third trimester and 40 days post partum
description: assessed using perineometry
measure: Pelvic Floor Muscle Contraction
time frame: Third trimester and 3 months post partum
description: assessed using perineometry
measure: Creatine Kinase
time frame: before labor, 24-48 hour post partum, and 7 days post partum
description: Assessed using appropriate reagent
measure: IGF-1
time frame: before labor, 24-48 hour post partum
description: Assessed using ELISA
measure: myoD
time frame: 7 days post partum
description: Assessed using ELISA
measure: Pain
time frame: before labor, 7 days post partum, 40 days post partum, and 3 months post partum
description: assessed using VAS
arm group label: Platelet rich plasma
arm group type: Experimental
description: Platelet rich plasma injected intramuscularly in pelvic floor muscle immediately following labor and before perineoraphy, simultaneously with the injection of local anesthesia
arm group label: Control
arm group type: No Intervention
description: No intervention given, patient will only get local anesthesia injection before perineoraphy
intervention type: Biological
intervention name: Platelet Rich Plasma
description: Platelet rich plasma is produced by obtaining patient's whole blood and processed by centrifugation and activation by CaCl2.
arm group label: Platelet rich plasma
other name: PRP
criteria: 
gender: Female
minimum age: 20 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Fernandi Moegni, MD,OBGYN(C)
role: Principal Investigator
affiliation: FKUI/RSCM
last name: Fernandi Moegni, MD,OBGYN(C)
phone: +6282298111778
email: fmoegni@yahoo.com
facility: 
status: Recruiting
contact: 
country: Indonesia
responsible party type: Principal Investigator
investigator affiliation: Dr Cipto Mangunkusumo General Hospital
investigator full name: Fernandi Moegni
investigator title: M.D., SpOG(K)
mesh term: Pelvic Floor Disorders
sharing ipd: No
submitted: March 22, 2022
returned: July 21, 2022
submitted: July 25, 2022
returned: June 29, 2023
submitted: July 6, 2023