<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/NCT03273569</url>
  </required_header>
  <id_info>
    <org_study_id>PDIUC001</org_study_id>
    <nct_id>NCT03273569</nct_id>
  </id_info>
  <brief_title>PDIUC Protocol for Placental Accreta</brief_title>
  <acronym>PDIUC</acronym>
  <official_title>Preplacental Delivery Intervention for Uterine Conservation Protocol: a Novel Approach for Management of Placenta Accreta</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</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>
      The aim of this study is to evaluate a novel protocol to conserve the uterus during Cesarean&#xD;
      delivery indicated for placenta accreta.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Placenta accreta is a morbid obstetric condition that describes variable non-physiologic&#xD;
      invasion of the placenta into the the uterine wall. The incidence of placenta accreta, as a&#xD;
      serious cause of postpartum hemorrhage, has substantially increased secondary to increase the&#xD;
      rate of Cesarean delivery. Placenta accreta is primarily managed by peripartum hysterectomy&#xD;
      prior to delivery of the placenta to avoid uncontrolled bleeding. However, in addition to the&#xD;
      surgical risks, hysterectomy is psychologically morbid to many women particularly younger&#xD;
      women and women with low parity. Therefore, several conservative options were studied to&#xD;
      provide an alternative for hysterectomy in these women. Our study is designated to evaluate a&#xD;
      proposed protocol of multi-step interventions to reduce the anticipated amount of bleeding&#xD;
      prior to delivery of the placenta.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">October 1, 2017</start_date>
  <completion_date type="Anticipated">June 1, 2018</completion_date>
  <primary_completion_date type="Anticipated">March 30, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Women with placenta accreta at the time of Cesarean delivery</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Uterine conservation</measure>
    <time_frame>Intra-operative (during the time of Cesarean delivery)</time_frame>
    <description>Successive Uterine conservation; no peripartum hysterectomy needed</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Primary postpartum hemorrhage</measure>
    <time_frame>From delivery of the fetus to 1 hour after delivery of the fetus</time_frame>
    <description>Amount of postpartum bleeding &gt; 1000 ml</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Severe primary postpartum hemorrhage</measure>
    <time_frame>From delivery of the fetus to 1 hour after delivery of the fetus</time_frame>
    <description>Amount of postpartum bleeding &gt; 1500 ml</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bladder injury</measure>
    <time_frame>Intra-operative (during the time of Cesarean delivery)</time_frame>
    <description>Incidental injury of the bladder during delivery of the placenta or control of bleeding</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bowel injury</measure>
    <time_frame>Intra-operative (during the time of Cesarean delivery)</time_frame>
    <description>Incidental injury of the bladder during delivery of the placenta or control of bleeding</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Surgical site infection</measure>
    <time_frame>Up to 2 weeks after Cesarean delivery</time_frame>
    <description>Cesarean wound infection</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Drop in hemoglobin level</measure>
    <time_frame>Hemoglobin is checked 1 hour prior to Cesarean delivery and again postoperative (24 and 72 hours after Cesarean delivery)</time_frame>
    <description>Change in hemoglobin before and more than 24 hours after delivery</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Placenta Accreta</condition>
  <arm_group>
    <arm_group_label>Women with placenta accreta</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>PDI-UC protocol</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>PDI-UC protocol</intervention_name>
    <description>Preplacental delivery intervention for uterine conservation protocol starts after delivery of the fetus during Cesarean delivery and consists of delayed cord clamping, intramyometrial injection of vasopressin, subdecidual injection of saline, ligation of the uterine arteries, multiple 8 compression sutures, followed by delivery of the placenta, application of pressure and interrupted sutures if needed</description>
    <arm_group_label>Women with placenta accreta</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women with diagnosis of placenta accreta (US or MRI based diagnosis)&#xD;
&#xD;
          -  Women who decline hysterectomy&#xD;
&#xD;
          -  Pregnancy at 28 weeks of gestation or beyond&#xD;
&#xD;
          -  Women who accept to participate in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Emergency Cesarean delivery (women with active bleeding)&#xD;
&#xD;
          -  Women with cardiac diseases&#xD;
&#xD;
          -  Women with coagulopathy&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Sherif Shazly, MBBCh, MSc</last_name>
    <phone>+15075131392</phone>
    <email>sherify2k2@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Ahmed Abbas, MBBCh, MD</last_name>
    <phone>+201003385183</phone>
    <email>bmr90@hotmail.com</email>
  </overall_contact_backup>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>August 5, 2017</study_first_submitted>
  <study_first_submitted_qc>September 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 6, 2017</study_first_posted>
  <last_update_submitted>September 4, 2017</last_update_submitted>
  <last_update_submitted_qc>September 4, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 6, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Sherif Abdelkarim Mohammed Shazly</investigator_full_name>
    <investigator_title>Assistant lecturer, OBGYN department; principal investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Placenta Accreta</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/NCT03273569
org study id: PDIUC001
nct id: NCT03273569
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to evaluate a novel protocol to conserve the uterus during Cesarean
      delivery indicated for placenta accreta.
Placenta accreta is a morbid obstetric condition that describes variable non-physiologic
      invasion of the placenta into the the uterine wall. The incidence of placenta accreta, as a
      serious cause of postpartum hemorrhage, has substantially increased secondary to increase the
      rate of Cesarean delivery. Placenta accreta is primarily managed by peripartum hysterectomy
      prior to delivery of the placenta to avoid uncontrolled bleeding. However, in addition to the
      surgical risks, hysterectomy is psychologically morbid to many women particularly younger
      women and women with low parity. Therefore, several conservative options were studied to
      provide an alternative for hysterectomy in these women. Our study is designated to evaluate a
      proposed protocol of multi-step interventions to reduce the anticipated amount of bleeding
      prior to delivery of the placenta.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Women with placenta accreta at the time of Cesarean delivery
primary purpose: Prevention
masking: None (Open Label)
measure: Uterine conservation
time frame: Intra-operative (during the time of Cesarean delivery)
description: Successive Uterine conservation; no peripartum hysterectomy needed
measure: Primary postpartum hemorrhage
time frame: From delivery of the fetus to 1 hour after delivery of the fetus
description: Amount of postpartum bleeding > 1000 ml
measure: Severe primary postpartum hemorrhage
time frame: From delivery of the fetus to 1 hour after delivery of the fetus
description: Amount of postpartum bleeding > 1500 ml
measure: Bladder injury
time frame: Intra-operative (during the time of Cesarean delivery)
description: Incidental injury of the bladder during delivery of the placenta or control of bleeding
measure: Bowel injury
time frame: Intra-operative (during the time of Cesarean delivery)
description: Incidental injury of the bladder during delivery of the placenta or control of bleeding
measure: Surgical site infection
time frame: Up to 2 weeks after Cesarean delivery
description: Cesarean wound infection
measure: Drop in hemoglobin level
time frame: Hemoglobin is checked 1 hour prior to Cesarean delivery and again postoperative (24 and 72 hours after Cesarean delivery)
description: Change in hemoglobin before and more than 24 hours after delivery
arm group label: Women with placenta accreta
arm group type: Experimental
description: PDI-UC protocol
intervention type: Procedure
intervention name: PDI-UC protocol
description: Preplacental delivery intervention for uterine conservation protocol starts after delivery of the fetus during Cesarean delivery and consists of delayed cord clamping, intramyometrial injection of vasopressin, subdecidual injection of saline, ligation of the uterine arteries, multiple 8 compression sutures, followed by delivery of the placenta, application of pressure and interrupted sutures if needed
arm group label: Women with placenta accreta
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: No
last name: Sherif Shazly, MBBCh, MSc
phone: +15075131392
email: sherify2k2@gmail.com
last name: Ahmed Abbas, MBBCh, MD
phone: +201003385183
email: bmr90@hotmail.com
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Sherif Abdelkarim Mohammed Shazly
investigator title: Assistant lecturer, OBGYN department; principal investigator
mesh term: Placenta Accreta
sharing ipd: No