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/NCT06030492</url>
    </required_header>
    <id_info>
      <org_study_id>MS-467-2023</org_study_id>
      <nct_id>NCT06030492</nct_id>
    </id_info>
    <brief_title>Efficacy of Hydrogen Peroxide ( H2O2) in Controlling Placental Site Bleeding in Caesarian Delivery for Placenta Previa / Accreta Spectrum ( PAS)</brief_title>
    <official_title>Efficacy of Hydrogen Peroxide ( H2O2) in Controlling Placental Site Bleeding in Caesarian Delivery for Placenta Previa / Accreta Spectrum ( PAS)</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 (1) . Currently,&#xD;
        more than 90% of women diagnosed with PAS also have a placenta praevia (2), and the&#xD;
        combination of both conditions leads to high maternal morbidity and mortality due to massive&#xD;
        haemorrhage at the time of birth . Maternal mortality of placenta praevia with percreta has&#xD;
        been reported to be as high as 7% of cases .&#xD;
  &#xD;
        Hydrogen peroxide is well-known for its antimicrobial and antiseptic properties. It is used&#xD;
        to clean surgical cuts for better localization of bleeding focus in surgery and orthopedics&#xD;
        and burn excisions to induce hemostasis . Topical application of hydrogen peroxide was proven&#xD;
        to induce hemostasis and reduce operative time in both tonsillectomy and adenoidectomy .&#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;
        The aim of the study is to evaluate the efficacy of hydrogen peroxide for controlling&#xD;
        bleeding from placental bed in caesarian section for placenta previa/ Accreta spectrum (PAS).&#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 : hydrogen peroxide group (n=42)&#xD;
  &#xD;
        Group B : control group (normal Saline solution) (n=42) .&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">January 1, 2023</start_date>
    <completion_date type="Anticipated">October 15, 2023</completion_date>
    <primary_completion_date type="Anticipated">September 30, 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 placental bed</measure>
      <time_frame>3 minutes after application of topical drug , identified as arrest of bleeding or minimal oozing from placental bed with good general condition &amp; no hemoglobin drop</time_frame>
      <description>control of intra-operative bleeding from placental bed</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Estimated intraoperative blood loss</measure>
      <time_frame>from begining to end of surgery</time_frame>
      <description>Estimated intraoperative blood loss by towel saturarion , amount of blood in suction , and pre&amp; postoperative hemoglobin and hematocrite</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Need for hemostatic sutures , uterine artery ligation , internal iliac artery ligation , hysterectomy</measure>
      <time_frame>3 minutes after topical application , if bleeding continued</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>within 1st 24 hours postoperative</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>
    <arm_group>
      <arm_group_label>hydrogen peroxide group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>hydrogen peroxide group Irrigation of the placental bed with 100 ml 3% hydrogen peroxide , followed by packing with a towel highly soaked hydrogen peroxide solution (Pozitif Kimya, İstanbul, Turkey) , freshly prepared by a 50% dilution with a normal saline solution.(</description>
    </arm_group>
    <arm_group>
      <arm_group_label>normal Saline solution</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Packing the placental bed with a towel soaked with normal Saline solution</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>packing placental site with hydrogen peroxide soaked towels</intervention_name>
      <description>Skin is incised either midline or Pfannenstiel incision according to clinical situation , bladder dissection will be done , uterus will be incised by transverse lower segment incision , followed by delivery of the baby.&#xD;
  Uterine massage , ecbolics &amp; a trial for delivery of the placenta will be done Irrigation of the placental bed with 100 ml 3% hydrogen peroxide , followed by packing with a towel highly soaked hydrogen peroxide solution (Pozitif Kimya, İstanbul, Turkey) , freshly prepared by a 50% dilution with a normal saline solution</description>
      <arm_group_label>hydrogen peroxide group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>normal Saline</intervention_name>
      <description>Skin is incised either midline or Pfannenstiel incision according to clinical situation , bladder dissection will be done , uterus will be incised by transverse lower segment incision , followed by delivery of the baby.&#xD;
  Uterine massage , ecbolics &amp; a trial for delivery of the placenta will be done.&#xD;
  Packing the placental bed with a towel soaked with normal Saline solution</description>
      <arm_group_label>normal Saline solution</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age from 18-40 years&#xD;
  &#xD;
            -  BMI &lt; 35 kg/m2&#xD;
  &#xD;
            -  Pregnant patients with placenta previa .&#xD;
  &#xD;
            -  Placenta accrete FIGO grade 1 .&#xD;
  &#xD;
            -  Vitally stable .&#xD;
  &#xD;
            -  Candidate for conservative management.&#xD;
  &#xD;
            -  No major intra-operative bleeding.&#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;
  &#xD;
            -  Placenta accrete , FIGO grades 2 or 3 .&#xD;
  &#xD;
            -  Not indicated for conservative management.&#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 infertility 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>Sheiner E, Sarid L, Levy A, Seidman DS, Hallak M. Obstetric risk factors and outcome of pregnancies complicated with early postpartum hemorrhage: a population-based study. J Matern Fetal Neonatal Med. 2005 Sep;18(3):149-54. doi: 10.1080/14767050500170088.</citation>
      <PMID>16272036</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>Wasserbauer S, Perez-Meza D, Chao R. Hydrogen peroxide and wound healing: a theoretical and practical review for hair transplant surgeons. Dermatol Surg. 2008 Jun;34(6):745-50. doi: 10.1111/j.1524-4725.2008.34141.x. Epub 2008 Mar 3.</citation>
      <PMID>18318724</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>Hydrogen Peroxide</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/NCT06030492
  org study id: MS-467-2023
  nct id: NCT06030492
  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 (1) . Currently,
        more than 90% of women diagnosed with PAS also have a placenta praevia (2), 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 .
  
        Hydrogen peroxide is well-known for its antimicrobial and antiseptic properties. It is used
        to clean surgical cuts for better localization of bleeding focus in surgery and orthopedics
        and burn excisions to induce hemostasis . Topical application of hydrogen peroxide was proven
        to induce hemostasis and reduce operative time in both tonsillectomy and adenoidectomy .
  -  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.
  
        The aim of the study is to evaluate the efficacy of hydrogen peroxide for controlling
        bleeding from placental bed in caesarian section for placenta previa/ Accreta spectrum (PAS).
  
        • 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 : hydrogen peroxide group (n=42)
  
        Group B : control group (normal Saline solution) (n=42) .
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Triple (Participant, Care Provider, Investigator)
  measure: control of intra-operative bleeding from placental bed
  time frame: 3 minutes after application of topical drug , identified as arrest of bleeding or minimal oozing from placental bed with good general condition & no hemoglobin drop
  description: control of intra-operative bleeding from placental bed
  measure: Estimated intraoperative blood loss
  time frame: from begining to end of surgery
  description: Estimated intraoperative blood loss by towel saturarion , amount of blood in suction , and pre& postoperative hemoglobin and hematocrite
  measure: Need for hemostatic sutures , uterine artery ligation , internal iliac artery ligation , hysterectomy
  time frame: 3 minutes after topical application , if bleeding continued
  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: within 1st 24 hours postoperative
  description: immediate maternal complications ( postpartum haemorrage , DIC , hysterectomy , maternal mortality , ICU admission , …)
  arm group label: hydrogen peroxide group
  arm group type: Experimental
  description: hydrogen peroxide group Irrigation of the placental bed with 100 ml 3% hydrogen peroxide , followed by packing with a towel highly soaked hydrogen peroxide solution (Pozitif Kimya, İstanbul, Turkey) , freshly prepared by a 50% dilution with a normal saline solution.(
  arm group label: normal Saline solution
  arm group type: Placebo Comparator
  description: Packing the placental bed with a towel soaked with normal Saline solution
  intervention type: Drug
  intervention name: packing placental site with hydrogen peroxide soaked towels
  description: Skin is incised either midline or Pfannenstiel incision according to clinical situation , bladder dissection will be done , uterus will be incised by transverse lower segment incision , followed by delivery of the baby.
  Uterine massage , ecbolics & a trial for delivery of the placenta will be done Irrigation of the placental bed with 100 ml 3% hydrogen peroxide , followed by packing with a towel highly soaked hydrogen peroxide solution (Pozitif Kimya, İstanbul, Turkey) , freshly prepared by a 50% dilution with a normal saline solution
  arm group label: hydrogen peroxide group
  intervention type: Drug
  intervention name: normal Saline
  description: Skin is incised either midline or Pfannenstiel incision according to clinical situation , bladder dissection will be done , uterus will be incised by transverse lower segment incision , followed by delivery of the baby.
  Uterine massage , ecbolics & a trial for delivery of the placenta will be done.
  Packing the placental bed with a towel soaked with normal Saline solution
  arm group label: normal Saline solution
  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: Sheiner E, Sarid L, Levy A, Seidman DS, Hallak M. Obstetric risk factors and outcome of pregnancies complicated with early postpartum hemorrhage: a population-based study. J Matern Fetal Neonatal Med. 2005 Sep;18(3):149-54. doi: 10.1080/14767050500170088.
  PMID: 16272036
  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: Wasserbauer S, Perez-Meza D, Chao R. Hydrogen peroxide and wound healing: a theoretical and practical review for hair transplant surgeons. Dermatol Surg. 2008 Jun;34(6):745-50. doi: 10.1111/j.1524-4725.2008.34141.x. Epub 2008 Mar 3.
  PMID: 18318724
  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: Hydrogen Peroxide
  sharing ipd: Undecided