<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/NCT04427592</url>
  </required_header>
  <id_info>
    <org_study_id>H.R501</org_study_id>
    <nct_id>NCT04427592</nct_id>
  </id_info>
  <brief_title>New Conservative Technique for Placenta Accreta Spectrum</brief_title>
  <acronym>percreta</acronym>
  <official_title>Placenta Accreta; A Vision for Conservative Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Alexandria University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Alexandria 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>
      participants diagnosed as placenta accreta spectrum were subjected to cesarean delivery.&#xD;
&#xD;
      Investigators manually detected a plan of cleavage through which the placenta was separated&#xD;
      followed by closure of defective placental bed.&#xD;
&#xD;
      Data were collected about the outcome.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Demographic data, detailed history taking, routine blood tests were done. Trans-abdominal and&#xD;
      trans-vaginal ultrasound to diagnose placenta accreta spectrum ( PAS). Detecting new signs to&#xD;
      help sure diagnosis of PAS.&#xD;
&#xD;
      Cesarean section will be performed through extended transverse supra-pubic incision bladder&#xD;
      dissection from anterior uterine wall using electro-coagulation instruments and double&#xD;
      ligation of large caliber bridging vessels.&#xD;
&#xD;
      Uterine incision above the placental bulge by at least 5 mm then complete separation of the&#xD;
      placenta starting from least resistance plans to high resistant one leaving a clear defect&#xD;
      which will be closed by running sutures from inside the uterus and controlling placental bed&#xD;
      hemorrhage then closing the uterine incision with compressing the bed from outwards ( double&#xD;
      compression sutures ) internal Iliac artery ligation may be done as a complementary measure&#xD;
      to control the bleeding from abnormal pelvic vasculature, insertion of intraperitoneal drain&#xD;
      and closure of abdominal wall in layers.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 28, 2020</start_date>
  <completion_date type="Anticipated">May 20, 2023</completion_date>
  <primary_completion_date type="Anticipated">April 20, 2023</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>Investigators conducting prospective study for management of placenta accreta spectrum including diagnosis and uterine sparing surgery.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>surgical outcome</measure>
    <time_frame>from the time of the surgery until 48 hours after.</time_frame>
    <description>number of participants whom their uterus were preserved without major hemorrhage</description>
  </primary_outcome>
  <primary_outcome>
    <measure>intra-operative blood loss</measure>
    <time_frame>intraoperative</time_frame>
    <description>the amount of blood loss during operation was estimated for each participant.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>surgical complications</measure>
    <time_frame>intraoperative</time_frame>
    <description>number of participants had bladder, ureter injury or hysterectomy,</description>
  </primary_outcome>
  <primary_outcome>
    <measure>internal iliac artery ligation</measure>
    <time_frame>intra-operative</time_frame>
    <description>number of participants had with either unilateral or bilateral internal iliac artery ligation</description>
  </primary_outcome>
  <primary_outcome>
    <measure>high dependency unit admission</measure>
    <time_frame>from 0 to 48 hours postoperative</time_frame>
    <description>number of participants needed high dependency unit admission</description>
  </primary_outcome>
  <primary_outcome>
    <measure>wound complications</measure>
    <time_frame>up to 2 weeks postoperative</time_frame>
    <description>number of patients suffered wound infection</description>
  </primary_outcome>
  <primary_outcome>
    <measure>change in the hemoglobin level</measure>
    <time_frame>from 48 hours pre operative to 48 hours post operative</time_frame>
    <description>participant's hemoglobin was measured</description>
  </primary_outcome>
  <primary_outcome>
    <measure>blood transfusion</measure>
    <time_frame>from 48 hours preoperative to 48 hours postoperative.</time_frame>
    <description>number of units of blood and it's products transfused to participants</description>
  </primary_outcome>
  <primary_outcome>
    <measure>hematuria</measure>
    <time_frame>post-operative up to 24 hours</time_frame>
    <description>number of participants suffered hematuria</description>
  </primary_outcome>
  <primary_outcome>
    <measure>manual cervical assesment</measure>
    <time_frame>before skin incision</time_frame>
    <description>participants were subjected to vaginal examination to asses the cervix lenght</description>
  </primary_outcome>
  <primary_outcome>
    <measure>placental separation</measure>
    <time_frame>intra-operative</time_frame>
    <description>number of participants whom their placenta was separated manually</description>
  </primary_outcome>
  <primary_outcome>
    <measure>surgical grading of the placenta</measure>
    <time_frame>intra-operative</time_frame>
    <description>number of participants who had accreta, increta, percreta or mixed type</description>
  </primary_outcome>
  <primary_outcome>
    <measure>ultrasound grading of the placenta</measure>
    <time_frame>pre-operative</time_frame>
    <description>number of participants who were diagnosed by ultrasound as accreta, increta or percreta</description>
  </primary_outcome>
  <primary_outcome>
    <measure>manual assessment of vaginal fornices</measure>
    <time_frame>before skin incision</time_frame>
    <description>participants were subjected to vaginal examination to assess fornices</description>
  </primary_outcome>
  <primary_outcome>
    <measure>repair time</measure>
    <time_frame>intra-operative</time_frame>
    <description>the time recorded from the end of the placental separation to the closure of the first layer of the uterus</description>
  </primary_outcome>
  <primary_outcome>
    <measure>total operation time</measure>
    <time_frame>intra-operative</time_frame>
    <description>the time taken from the start of the skin incision to the skin closure</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>placental bed</measure>
    <time_frame>intra-operative</time_frame>
    <description>number of participants that investigators detected a well delineated placental bed like a pouch</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>pouch site</measure>
    <time_frame>intra-operative</time_frame>
    <description>the site of the pouch in relation to the cervix</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>defect site</measure>
    <time_frame>intra-operative</time_frame>
    <description>the location of the myometrium defects</description>
  </secondary_outcome>
  <other_outcome>
    <measure>new ultrasound sign the pouch</measure>
    <time_frame>pre-operative</time_frame>
    <description>number of participants that the investigators detected the previously noticed pouch by ultrasound.</description>
  </other_outcome>
  <other_outcome>
    <measure>significance of the pouch</measure>
    <time_frame>peri-operative</time_frame>
    <description>the investigators determine the relation of the pouch to estimated blood loss</description>
  </other_outcome>
  <other_outcome>
    <measure>Pathology</measure>
    <time_frame>From the operation time for 48 hours</time_frame>
    <description>Histopathological examination of 1 cm specimen from the myometriam attached to the placenta in random cases</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">120</enrollment>
  <condition>Placenta Accreta Spectrum</condition>
  <arm_group>
    <arm_group_label>pregnant women with placenta accreta spectrum</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The participants were subjected to ultrasound to diagnose placenta accreta spectrum followed by new conservative surgical technique.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>ultrasound</intervention_name>
    <description>trans-vaginal and trans-abdominal ultrasound using different modalities such as grey-scale, Doppler, multi-planer mode</description>
    <arm_group_label>pregnant women with placenta accreta spectrum</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>closure of uterine wall defect</intervention_name>
    <description>uterine incision above placental bulge by at least 5 mm then complete separation of the placenta starting from areas of least resistance to areas of high resistance leaving a clear defect which will be closed by non locked running sutures from inside the uterus starting from one edge, hitch the bed to the other edge of the defect and controlling placental bed hemorrhage then closing the uterine incision via running sutures in 2 layers with compressing the bed from outwards in the first layer. hemostasis of the abnormal pelvic vasculature if excessive bleeding internal iliac artery may be ligated then insertion of intra-peritoneal drain followed by closing the abdomen.</description>
    <arm_group_label>pregnant women with placenta accreta spectrum</arm_group_label>
    <other_name>Double compression suture</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  pregnant women diagnosed as placenta accreta spectrum with previous Cesarean section,&#xD;
             with or without other uterine surgeries and less than 40 years of age.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnant women having medical conditions such as cardiac diseases, coagulopathy and&#xD;
             hematological disorders.&#xD;
&#xD;
        pregnant women had 5 or more previous Cesarean sections or their age more than 40 years&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mahmoud AH Hamdy, A. lecturer</last_name>
    <role>Principal Investigator</role>
    <affiliation>faculty of medicine department of obstetrics and gyneacology</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Mahmoud AH Hamdy, A. lecturer</last_name>
    <phone>00201229102311</phone>
    <email>mahmoud_hamdy81@yahoo.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Omar YS Elshorbagy, A. lecturer</last_name>
    <phone>00201111362322</phone>
    <email>oyke2011@hotmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Faculty of Medicine</name>
      <address>
        <city>Alexandria</city>
        <zip>21131</zip>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Mahmoud AH Hamdy, A. lecturer</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Omar YS Elshorbagy, A. lecturer</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <results_reference>
    <citation>Sentilhes L, Kayem G, Chandraharan E, Palacios-Jaraquemada J, Jauniaux E; FIGO Placenta Accreta Diagnosis and Management Expert Consensus Panel. FIGO consensus guidelines on placenta accreta spectrum disorders: Conservative management. Int J Gynaecol Obstet. 2018 Mar;140(3):291-298. doi: 10.1002/ijgo.12410. No abstract available.</citation>
    <PMID>29405320</PMID>
  </results_reference>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>May 31, 2020</study_first_submitted>
  <study_first_submitted_qc>June 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>December 9, 2022</last_update_submitted>
  <last_update_submitted_qc>December 9, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 12, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Alexandria University</investigator_affiliation>
    <investigator_full_name>Mahmoud A Hamdy</investigator_full_name>
    <investigator_title>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>Yes</sharing_ipd>
    <ipd_description>all IPD that underlies results in publication</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_time_frame>after publication by 1 month</ipd_time_frame>
  </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/NCT04427592
org study id: H.R501
nct id: NCT04427592
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
participants diagnosed as placenta accreta spectrum were subjected to cesarean delivery.

      Investigators manually detected a plan of cleavage through which the placenta was separated
      followed by closure of defective placental bed.

      Data were collected about the outcome.
Demographic data, detailed history taking, routine blood tests were done. Trans-abdominal and
      trans-vaginal ultrasound to diagnose placenta accreta spectrum ( PAS). Detecting new signs to
      help sure diagnosis of PAS.

      Cesarean section will be performed through extended transverse supra-pubic incision bladder
      dissection from anterior uterine wall using electro-coagulation instruments and double
      ligation of large caliber bridging vessels.

      Uterine incision above the placental bulge by at least 5 mm then complete separation of the
      placenta starting from least resistance plans to high resistant one leaving a clear defect
      which will be closed by running sutures from inside the uterus and controlling placental bed
      hemorrhage then closing the uterine incision with compressing the bed from outwards ( double
      compression sutures ) internal Iliac artery ligation may be done as a complementary measure
      to control the bleeding from abnormal pelvic vasculature, insertion of intraperitoneal drain
      and closure of abdominal wall in layers.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Investigators conducting prospective study for management of placenta accreta spectrum including diagnosis and uterine sparing surgery.
primary purpose: Treatment
masking: None (Open Label)
measure: surgical outcome
time frame: from the time of the surgery until 48 hours after.
description: number of participants whom their uterus were preserved without major hemorrhage
measure: intra-operative blood loss
time frame: intraoperative
description: the amount of blood loss during operation was estimated for each participant.
measure: surgical complications
time frame: intraoperative
description: number of participants had bladder, ureter injury or hysterectomy,
measure: internal iliac artery ligation
time frame: intra-operative
description: number of participants had with either unilateral or bilateral internal iliac artery ligation
measure: high dependency unit admission
time frame: from 0 to 48 hours postoperative
description: number of participants needed high dependency unit admission
measure: wound complications
time frame: up to 2 weeks postoperative
description: number of patients suffered wound infection
measure: change in the hemoglobin level
time frame: from 48 hours pre operative to 48 hours post operative
description: participant's hemoglobin was measured
measure: blood transfusion
time frame: from 48 hours preoperative to 48 hours postoperative.
description: number of units of blood and it's products transfused to participants
measure: hematuria
time frame: post-operative up to 24 hours
description: number of participants suffered hematuria
measure: manual cervical assesment
time frame: before skin incision
description: participants were subjected to vaginal examination to asses the cervix lenght
measure: placental separation
time frame: intra-operative
description: number of participants whom their placenta was separated manually
measure: surgical grading of the placenta
time frame: intra-operative
description: number of participants who had accreta, increta, percreta or mixed type
measure: ultrasound grading of the placenta
time frame: pre-operative
description: number of participants who were diagnosed by ultrasound as accreta, increta or percreta
measure: manual assessment of vaginal fornices
time frame: before skin incision
description: participants were subjected to vaginal examination to assess fornices
measure: repair time
time frame: intra-operative
description: the time recorded from the end of the placental separation to the closure of the first layer of the uterus
measure: total operation time
time frame: intra-operative
description: the time taken from the start of the skin incision to the skin closure
measure: placental bed
time frame: intra-operative
description: number of participants that investigators detected a well delineated placental bed like a pouch
measure: pouch site
time frame: intra-operative
description: the site of the pouch in relation to the cervix
measure: defect site
time frame: intra-operative
description: the location of the myometrium defects
measure: new ultrasound sign the pouch
time frame: pre-operative
description: number of participants that the investigators detected the previously noticed pouch by ultrasound.
measure: significance of the pouch
time frame: peri-operative
description: the investigators determine the relation of the pouch to estimated blood loss
measure: Pathology
time frame: From the operation time for 48 hours
description: Histopathological examination of 1 cm specimen from the myometriam attached to the placenta in random cases
arm group label: pregnant women with placenta accreta spectrum
arm group type: Experimental
description: The participants were subjected to ultrasound to diagnose placenta accreta spectrum followed by new conservative surgical technique.
intervention type: Diagnostic Test
intervention name: ultrasound
description: trans-vaginal and trans-abdominal ultrasound using different modalities such as grey-scale, Doppler, multi-planer mode
arm group label: pregnant women with placenta accreta spectrum
intervention type: Procedure
intervention name: closure of uterine wall defect
description: uterine incision above placental bulge by at least 5 mm then complete separation of the placenta starting from areas of least resistance to areas of high resistance leaving a clear defect which will be closed by non locked running sutures from inside the uterus starting from one edge, hitch the bed to the other edge of the defect and controlling placental bed hemorrhage then closing the uterine incision via running sutures in 2 layers with compressing the bed from outwards in the first layer. hemostasis of the abnormal pelvic vasculature if excessive bleeding internal iliac artery may be ligated then insertion of intra-peritoneal drain followed by closing the abdomen.
arm group label: pregnant women with placenta accreta spectrum
other name: Double compression suture
criteria: 
gender: Female
minimum age: 19 Years
maximum age: 40 Years
healthy volunteers: No
last name: Mahmoud AH Hamdy, A. lecturer
role: Principal Investigator
affiliation: faculty of medicine department of obstetrics and gyneacology
last name: Mahmoud AH Hamdy, A. lecturer
phone: 00201229102311
email: mahmoud_hamdy81@yahoo.com
last name: Omar YS Elshorbagy, A. lecturer
phone: 00201111362322
email: oyke2011@hotmail.com
facility: 
status: Recruiting
investigator: 
investigator: 
country: Egypt
citation: Sentilhes L, Kayem G, Chandraharan E, Palacios-Jaraquemada J, Jauniaux E; FIGO Placenta Accreta Diagnosis and Management Expert Consensus Panel. FIGO consensus guidelines on placenta accreta spectrum disorders: Conservative management. Int J Gynaecol Obstet. 2018 Mar;140(3):291-298. doi: 10.1002/ijgo.12410. No abstract available.
PMID: 29405320
responsible party type: Principal Investigator
investigator affiliation: Alexandria University
investigator full name: Mahmoud A Hamdy
investigator title: principal investigator
mesh term: Placenta Accreta
sharing ipd: Yes
ipd description: all IPD that underlies results in publication
ipd info type: Study Protocol
ipd time frame: after publication by 1 month