xml: <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/NCT06030479</url>
    </required_header>
    <id_info>
      <org_study_id>MS-469-2023</org_study_id>
      <nct_id>NCT06030479</nct_id>
    </id_info>
    <brief_title>Topical Adrenaline Versus Warm Saline Solution for Minimizing Intraperitoneal Bleeding During Caesarian Delivery for Placenta Previa / Accreta Spectrum ( PAS)</brief_title>
    <official_title>Topical Adrenaline Versus Warm Saline Solution for Minimizing Intraperitoneal Bleeding During Caesarian Delivery for Placenta Previa / Accreta Spectrum ( PAS): A Randomized Controlled Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Cairo University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Cairo University</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Placenta accreta spectrum (PAS), encompassing the terms placenta accreta, increta, and&#xD;
        percreta; abnormally invasive placenta; morbidly adherent placenta; and invasive&#xD;
        placentation, is a leading cause of life-threatening obstetric haemorrage . Currently, more&#xD;
        than 90% of women diagnosed with PAS also have a placenta praevia , and the combination of&#xD;
        both conditions leads to high maternal morbidity and mortality due to massive haemorrhage at&#xD;
        the time of birth . Maternal mortality of placenta praevia with percreta has been reported to&#xD;
        be as high as 7% of cases .&#xD;
  &#xD;
        Adrenaline has also been demonstrated to be a reasonable hemostatic agent because of its low&#xD;
        cost, low risk, powerful vasoconstrictor, and platelet aggregation. Topical use of adrenaline&#xD;
        is an effective and reasonable hemostatic agent in tonsillectomy.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        -  Population of study: A total of 84 pregnant patients with placenta previa / Accreta&#xD;
             spectrum.&#xD;
  &#xD;
          -  Study location: Obstetrics and Gynecology Kasr Al-Ainy Hospital , Faculty of Medicine ,&#xD;
             Cairo University.&#xD;
  &#xD;
        This is a randomized controlled trial including a total number of 84 patients representing&#xD;
        study group , randomized in 2 equal groups , using computer generated randomization sheet on&#xD;
        (Medcalc ®) .&#xD;
  &#xD;
        Group A : Topical adrenaline group (n=42)&#xD;
  &#xD;
        Group B : Warm saline Group (control) (n=42)&#xD;
  &#xD;
        The aim of the study is to evaluate the efficacy of topical adrenaline for decreasing&#xD;
        intraperitoneal bleeding during caesarian section for placenta previa/ Accreta spectrum&#xD;
        (PAS).&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">February 1, 2023</start_date>
    <completion_date type="Anticipated">October 25, 2023</completion_date>
    <primary_completion_date type="Anticipated">October 15, 2023</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>Treatment</primary_purpose>
      <masking>Triple (Participant, Care Provider, Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>control of intra-operative bleeding from surgical field.</measure>
      <time_frame>30 minutes after application of topical drug</time_frame>
      <description>control of intra-operative bleeding from surgical field if bleeding stopped , or minimal oozing , towel are not soaked with blood and improvement of general condition with no hemoglobin drop.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Need for hemostatic sutures , uterine artery ligation , internal iliac artery ligation , hysterectomy</measure>
      <time_frame>if bleeding continued 30 minutes after topical drugs</time_frame>
      <description>Need for hemostatic sutures , uterine artery ligation , internal iliac artery ligation , hysterectomy</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>immediate maternal complications ( postpartum haemorrage , DIC , hysterectomy , maternal mortality , ICU admission , …)</measure>
      <time_frame>24 hours after delivery</time_frame>
      <description>immediate maternal complications ( postpartum haemorrage , DIC , hysterectomy , maternal mortality , ICU admission , …)</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">84</enrollment>
    <condition>Placenta Accreta</condition>
    <condition>Placenta Previa</condition>
    <arm_group>
      <arm_group_label>Topical Adrenaline Group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Topical adrenaline group</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Warm saline Group</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Warm saline Group</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Topical adrenaline</intervention_name>
      <description>Skin is incised midline sub-umbilical incision , bladder dissection will be done , uterus will be incised by vertical upper segment incision , followed by delivery of the baby.&#xD;
  Surgical assessment and decision for either conservative management or CS hysterectomy will be done.&#xD;
  After completion of surgical procedure , surgical field is observed for major bleeding and patients are subjected to intervention Packing the pelvic surgical field with towels fully saturated with adrenaline 1:10000 solution.</description>
      <arm_group_label>Topical Adrenaline Group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Warm saline</intervention_name>
      <description>Skin is incised midline sub-umbilical incision , bladder dissection will be done , uterus will be incised by vertical upper segment incision , followed by delivery of the baby.&#xD;
  Surgical assessment and decision for either conservative management or CS hysterectomy will be done.&#xD;
  After completion of surgical procedure , surgical field is observed for major bleeding and patients are subjected to intervention Packing the surgical field with towels fully saturated with warm saline solution ( 50 degrees).</description>
      <arm_group_label>Warm saline Group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age from 18 to 40 years.&#xD;
  &#xD;
            -  BMI &lt; 35.&#xD;
  &#xD;
            -  Pregnant patients with placenta previa .&#xD;
  &#xD;
            -  Placenta accrete spectrum.&#xD;
  &#xD;
            -  Vitally stable .&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Vitally unstable .&#xD;
  &#xD;
            -  Massive pre- or intra-operative bleeding.&#xD;
  &#xD;
            -  Medical disorders ( e.g. : hypertension , cardiac …. )&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <gender_based>Yes</gender_based>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>40 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>bassiony dabian, MD</last_name>
      <phone>1095195513</phone>
      <email>bassiony.dabian@gmail.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Kasr Alainy outpatient clinic</name>
        <address>
          <city>Cairo</city>
          <country>Egypt</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>bassiony dabian, MD</last_name>
        <phone>1095195513</phone>
        <email>bassiony.dabian@gmail.com</email>
      </contact>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <reference>
      <citation>Solheim KN, Esakoff TF, Little SE, Cheng YW, Sparks TN, Caughey AB. The effect of cesarean delivery rates on the future incidence of placenta previa, placenta accreta, and maternal mortality. J Matern Fetal Neonatal Med. 2011 Nov;24(11):1341-6. doi: 10.3109/14767058.2011.553695. Epub 2011 Mar 7.</citation>
      <PMID>21381881</PMID>
    </reference>
    <reference>
      <citation>Jauniaux E, Bhide A, Kennedy A, Woodward P, Hubinont C, Collins S; FIGO Placenta Accreta Diagnosis and Management Expert Consensus Panel. FIGO consensus guidelines on placenta accreta spectrum disorders: Prenatal diagnosis and screening. Int J Gynaecol Obstet. 2018 Mar;140(3):274-280. doi: 10.1002/ijgo.12408. No abstract available.</citation>
      <PMID>29405319</PMID>
    </reference>
    <reference>
      <citation>Hatton RC. Bismuth subgallate-epinephrine paste in adenotonsillectomies. Ann Pharmacother. 2000 Apr;34(4):522-5. doi: 10.1345/aph.19216.</citation>
      <PMID>10772440</PMID>
    </reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 28, 2023</study_first_submitted>
    <study_first_submitted_qc>September 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 11, 2023</study_first_posted>
    <last_update_submitted>September 1, 2023</last_update_submitted>
    <last_update_submitted_qc>September 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 11, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Cairo University</investigator_affiliation>
      <investigator_full_name>Bassiony Dabian</investigator_full_name>
      <investigator_title>lecturer of obstetrics and gynecology</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Placenta Accreta</mesh_term>
      <mesh_term>Placenta Previa</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Epinephrine</mesh_term>
      <mesh_term>Racepinephrine</mesh_term>
      <mesh_term>Epinephryl borate</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06030479
  org study id: MS-469-2023
  nct id: NCT06030479
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Placenta accreta spectrum (PAS), encompassing the terms placenta accreta, increta, and
        percreta; abnormally invasive placenta; morbidly adherent placenta; and invasive
        placentation, is a leading cause of life-threatening obstetric haemorrage . Currently, more
        than 90% of women diagnosed with PAS also have a placenta praevia , and the combination of
        both conditions leads to high maternal morbidity and mortality due to massive haemorrhage at
        the time of birth . Maternal mortality of placenta praevia with percreta has been reported to
        be as high as 7% of cases .
  
        Adrenaline has also been demonstrated to be a reasonable hemostatic agent because of its low
        cost, low risk, powerful vasoconstrictor, and platelet aggregation. Topical use of adrenaline
        is an effective and reasonable hemostatic agent in tonsillectomy.
  -  Population of study: A total of 84 pregnant patients with placenta previa / Accreta
             spectrum.
  
          -  Study location: Obstetrics and Gynecology Kasr Al-Ainy Hospital , Faculty of Medicine ,
             Cairo University.
  
        This is a randomized controlled trial including a total number of 84 patients representing
        study group , randomized in 2 equal groups , using computer generated randomization sheet on
        (Medcalc ®) .
  
        Group A : Topical adrenaline group (n=42)
  
        Group B : Warm saline Group (control) (n=42)
  
        The aim of the study is to evaluate the efficacy of topical adrenaline for decreasing
        intraperitoneal bleeding during caesarian section for placenta previa/ Accreta spectrum
        (PAS).
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Triple (Participant, Care Provider, Investigator)
  measure: control of intra-operative bleeding from surgical field.
  time frame: 30 minutes after application of topical drug
  description: control of intra-operative bleeding from surgical field if bleeding stopped , or minimal oozing , towel are not soaked with blood and improvement of general condition with no hemoglobin drop.
  measure: Need for hemostatic sutures , uterine artery ligation , internal iliac artery ligation , hysterectomy
  time frame: if bleeding continued 30 minutes after topical drugs
  description: Need for hemostatic sutures , uterine artery ligation , internal iliac artery ligation , hysterectomy
  measure: immediate maternal complications ( postpartum haemorrage , DIC , hysterectomy , maternal mortality , ICU admission , …)
  time frame: 24 hours after delivery
  description: immediate maternal complications ( postpartum haemorrage , DIC , hysterectomy , maternal mortality , ICU admission , …)
  arm group label: Topical Adrenaline Group
  arm group type: Experimental
  description: Topical adrenaline group
  arm group label: Warm saline Group
  arm group type: Placebo Comparator
  description: Warm saline Group
  intervention type: Drug
  intervention name: Topical adrenaline
  description: Skin is incised midline sub-umbilical incision , bladder dissection will be done , uterus will be incised by vertical upper segment incision , followed by delivery of the baby.
  Surgical assessment and decision for either conservative management or CS hysterectomy will be done.
  After completion of surgical procedure , surgical field is observed for major bleeding and patients are subjected to intervention Packing the pelvic surgical field with towels fully saturated with adrenaline 1:10000 solution.
  arm group label: Topical Adrenaline Group
  intervention type: Drug
  intervention name: Warm saline
  description: Skin is incised midline sub-umbilical incision , bladder dissection will be done , uterus will be incised by vertical upper segment incision , followed by delivery of the baby.
  Surgical assessment and decision for either conservative management or CS hysterectomy will be done.
  After completion of surgical procedure , surgical field is observed for major bleeding and patients are subjected to intervention Packing the surgical field with towels fully saturated with warm saline solution ( 50 degrees).
  arm group label: Warm saline Group
  criteria: 
  gender: Female
  gender based: Yes
  minimum age: 18 Years
  maximum age: 40 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: bassiony dabian, MD
  phone: 1095195513
  email: bassiony.dabian@gmail.com
  facility: 
  status: Recruiting
  contact: 
  country: Egypt
  citation: Solheim KN, Esakoff TF, Little SE, Cheng YW, Sparks TN, Caughey AB. The effect of cesarean delivery rates on the future incidence of placenta previa, placenta accreta, and maternal mortality. J Matern Fetal Neonatal Med. 2011 Nov;24(11):1341-6. doi: 10.3109/14767058.2011.553695. Epub 2011 Mar 7.
  PMID: 21381881
  citation: Jauniaux E, Bhide A, Kennedy A, Woodward P, Hubinont C, Collins S; FIGO Placenta Accreta Diagnosis and Management Expert Consensus Panel. FIGO consensus guidelines on placenta accreta spectrum disorders: Prenatal diagnosis and screening. Int J Gynaecol Obstet. 2018 Mar;140(3):274-280. doi: 10.1002/ijgo.12408. No abstract available.
  PMID: 29405319
  citation: Hatton RC. Bismuth subgallate-epinephrine paste in adenotonsillectomies. Ann Pharmacother. 2000 Apr;34(4):522-5. doi: 10.1345/aph.19216.
  PMID: 10772440
  responsible party type: Principal Investigator
  investigator affiliation: Cairo University
  investigator full name: Bassiony Dabian
  investigator title: lecturer of obstetrics and gynecology
  mesh term: Placenta Accreta
  mesh term: Placenta Previa
  mesh term: Epinephrine
  mesh term: Racepinephrine
  mesh term: Epinephryl borate
  sharing ipd: Undecided