<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/NCT02997397</url>
  </required_header>
  <id_info>
    <org_study_id>IR-2016-01</org_study_id>
    <nct_id>NCT02997397</nct_id>
  </id_info>
  <brief_title>A Novel Tourniquet Technic for Massive PPH</brief_title>
  <acronym>PPH</acronym>
  <official_title>A Novel Atraumatic Tourniquet Technique in Cases of Excessive Bleeding During Cesarean Section</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Irenbe</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Irenbe</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In this study, the investigators aimed to find out the effect of a novel tourniquet&#xD;
      technique, in cases of excessive bleeding during cesarean delivery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In this retrospective comparative study, the investigators compared the peripartum features&#xD;
      of patients who experienced profuse postpartum bleeding during C/S and this novel atraumatic&#xD;
      tourniquet technique was used and not used.&#xD;
&#xD;
      In this technique; the uterus is exteriorized following the delivery of the baby and before&#xD;
      the removal of the placenta to be able to apply the tourniquet technique. In this technique&#xD;
      it is not obligatory to push the bladder before the procedure. Afterwards, the surgeon and&#xD;
      the assistant palpate the ureters with both hands in the two sheaths of broad ligament and&#xD;
      try to hear a 'click' sound which comes from ureter sliding out between both fingers. After&#xD;
      confirming that the ureters are not in the surgical site, an atraumatic vascular DeBakey&#xD;
      clamp is applied widely including both the infundibulopelvic ligament and uterine arteries.&#xD;
      Thus, two-sided blood supply of the uterus is reduced significantly and this gives the&#xD;
      surgeon some time, for planning further surgical procedures and also serves a minimal bloody&#xD;
      surgical site. If the avascular state of the surgical site is needed for a prolonged time,&#xD;
      for instance while preparing for a blood transfusion or while waiting until an experienced&#xD;
      surgeon is available, the clamps were opened and closed intermittently for a maximum of 10&#xD;
      minutes, as to sustain the blood supply of the ovaries and the uterus.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2013</start_date>
  <completion_date type="Actual">April 2016</completion_date>
  <primary_completion_date type="Actual">February 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Hemoglobin values</measure>
    <time_frame>1 hour</time_frame>
    <description>The differences in hemoglobin values just before the surgery and immediately after the surgery</description>
  </primary_outcome>
  <primary_outcome>
    <measure>red blood cell transfusion</measure>
    <time_frame>24 hours</time_frame>
    <description>the amount of packed red blood cells, required for haemodynamic stability in the first 24 hour.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>fresh frozen plasma transfusion</measure>
    <time_frame>24 hours</time_frame>
    <description>the amount of packed fresh frozen plasma, required for haemodynamic stability in the first 24 hour.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">37</enrollment>
  <condition>Postpartum Hemorrhage</condition>
  <arm_group>
    <arm_group_label>tourniquet (+)</arm_group_label>
    <description>The cases in which the tourniquet technique is used</description>
  </arm_group>
  <arm_group>
    <arm_group_label>tourniquet(-)</arm_group_label>
    <description>The cases in which the tourniquet technique is not used</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>tourniquet(+)</intervention_name>
    <description>A novel atraumatic tourniquet technique, applied via placing a vascular clamp widely on both the infundibulopelvic ligament and uterine arteries.</description>
    <arm_group_label>tourniquet (+)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>tourniquet(-)</intervention_name>
    <arm_group_label>tourniquet(-)</arm_group_label>
    <other_name>The tourniquet was not used</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Two groups of women who experienced profuse bleeding during C/S; one group in which a novel&#xD;
        tourniquet technique was used and another group in which the tourniquet technique was not&#xD;
        used.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The women who experienced profuse postpartum haemorrhage during cesarean section&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  none defined&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Barış Büke, resident</last_name>
    <role>Principal Investigator</role>
    <affiliation>İRENBE</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ege University</name>
      <address>
        <city>Izmir</city>
        <zip>35040</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <results_reference>
    <citation>B-Lynch C, Coker A, Lawal AH, Abu J, Cowen MJ. The B-Lynch surgical technique for the control of massive postpartum haemorrhage: an alternative to hysterectomy? Five cases reported. Br J Obstet Gynaecol. 1997 Mar;104(3):372-5. doi: 10.1111/j.1471-0528.1997.tb11471.x.</citation>
    <PMID>9091019</PMID>
  </results_reference>
  <results_reference>
    <citation>Hayman RG, Arulkumaran S, Steer PJ. Uterine compression sutures: surgical management of postpartum hemorrhage. Obstet Gynecol. 2002 Mar;99(3):502-6. doi: 10.1016/s0029-7844(01)01643-x.</citation>
    <PMID>11864681</PMID>
  </results_reference>
  <results_reference>
    <citation>AbdRabbo SA. Stepwise uterine devascularization: a novel technique for management of uncontrolled postpartum hemorrhage with preservation of the uterus. Am J Obstet Gynecol. 1994 Sep;171(3):694-700. doi: 10.1016/0002-9378(94)90084-1.</citation>
    <PMID>8092217</PMID>
  </results_reference>
  <results_reference>
    <citation>Ikeda T, Sameshima H, Kawaguchi H, Yamauchi N, Ikenoue T. Tourniquet technique prevents profuse blood loss in placenta accreta cesarean section. J Obstet Gynaecol Res. 2005 Feb;31(1):27-31. doi: 10.1111/j.1447-0756.2005.00247.x.</citation>
    <PMID>15669988</PMID>
  </results_reference>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 10, 2016</study_first_submitted>
  <study_first_submitted_qc>December 15, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 20, 2016</study_first_posted>
  <last_update_submitted>December 15, 2016</last_update_submitted>
  <last_update_submitted_qc>December 15, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 20, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Irenbe</investigator_affiliation>
    <investigator_full_name>Baris Buke</investigator_full_name>
    <investigator_title>M.D.</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Postpartum Hemorrhage</mesh_term>
    <mesh_term>Hemorrhage</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>If needed</ipd_description>
  </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/NCT02997397
org study id: IR-2016-01
nct id: NCT02997397
lead sponsor: 
has dmc: No
In this study, the investigators aimed to find out the effect of a novel tourniquet
      technique, in cases of excessive bleeding during cesarean delivery.
In this retrospective comparative study, the investigators compared the peripartum features
      of patients who experienced profuse postpartum bleeding during C/S and this novel atraumatic
      tourniquet technique was used and not used.

      In this technique; the uterus is exteriorized following the delivery of the baby and before
      the removal of the placenta to be able to apply the tourniquet technique. In this technique
      it is not obligatory to push the bladder before the procedure. Afterwards, the surgeon and
      the assistant palpate the ureters with both hands in the two sheaths of broad ligament and
      try to hear a 'click' sound which comes from ureter sliding out between both fingers. After
      confirming that the ureters are not in the surgical site, an atraumatic vascular DeBakey
      clamp is applied widely including both the infundibulopelvic ligament and uterine arteries.
      Thus, two-sided blood supply of the uterus is reduced significantly and this gives the
      surgeon some time, for planning further surgical procedures and also serves a minimal bloody
      surgical site. If the avascular state of the surgical site is needed for a prolonged time,
      for instance while preparing for a blood transfusion or while waiting until an experienced
      surgeon is available, the clamps were opened and closed intermittently for a maximum of 10
      minutes, as to sustain the blood supply of the ovaries and the uterus.
observational model: Case-Control
time perspective: Retrospective
measure: Hemoglobin values
time frame: 1 hour
description: The differences in hemoglobin values just before the surgery and immediately after the surgery
measure: red blood cell transfusion
time frame: 24 hours
description: the amount of packed red blood cells, required for haemodynamic stability in the first 24 hour.
measure: fresh frozen plasma transfusion
time frame: 24 hours
description: the amount of packed fresh frozen plasma, required for haemodynamic stability in the first 24 hour.
arm group label: tourniquet (+)
description: The cases in which the tourniquet technique is used
arm group label: tourniquet(-)
description: The cases in which the tourniquet technique is not used
intervention type: Procedure
intervention name: tourniquet(+)
description: A novel atraumatic tourniquet technique, applied via placing a vascular clamp widely on both the infundibulopelvic ligament and uterine arteries.
arm group label: tourniquet (+)
intervention type: Procedure
intervention name: tourniquet(-)
arm group label: tourniquet(-)
other name: The tourniquet was not used
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 35 Years
healthy volunteers: No
last name: Barış Büke, resident
role: Principal Investigator
affiliation: İRENBE
facility: 
country: Turkey
citation: B-Lynch C, Coker A, Lawal AH, Abu J, Cowen MJ. The B-Lynch surgical technique for the control of massive postpartum haemorrhage: an alternative to hysterectomy? Five cases reported. Br J Obstet Gynaecol. 1997 Mar;104(3):372-5. doi: 10.1111/j.1471-0528.1997.tb11471.x.
PMID: 9091019
citation: Hayman RG, Arulkumaran S, Steer PJ. Uterine compression sutures: surgical management of postpartum hemorrhage. Obstet Gynecol. 2002 Mar;99(3):502-6. doi: 10.1016/s0029-7844(01)01643-x.
PMID: 11864681
citation: AbdRabbo SA. Stepwise uterine devascularization: a novel technique for management of uncontrolled postpartum hemorrhage with preservation of the uterus. Am J Obstet Gynecol. 1994 Sep;171(3):694-700. doi: 10.1016/0002-9378(94)90084-1.
PMID: 8092217
citation: Ikeda T, Sameshima H, Kawaguchi H, Yamauchi N, Ikenoue T. Tourniquet technique prevents profuse blood loss in placenta accreta cesarean section. J Obstet Gynaecol Res. 2005 Feb;31(1):27-31. doi: 10.1111/j.1447-0756.2005.00247.x.
PMID: 15669988
responsible party type: Principal Investigator
investigator affiliation: Irenbe
investigator full name: Baris Buke
investigator title: M.D.
mesh term: Postpartum Hemorrhage
mesh term: Hemorrhage
sharing ipd: Yes
ipd description: If needed