<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/NCT03777696</url>
  </required_header>
  <id_info>
    <org_study_id>aswu /185/18</org_study_id>
    <nct_id>NCT03777696</nct_id>
  </id_info>
  <brief_title>Buccal Misoprostol and Intravenous Tranexamic Acid During Emergent Cesarean Delivery</brief_title>
  <official_title>A Randomized Controlled Trial Comparing Co-administered Buccal Misoprostol and Intravenous Tranexamic Acid, Versus Buccal Misoprostol Alone for the Prevention of Postpartum Hemorrhage Following an Emergent Cesarean Delivery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>hany farouk</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Aswan University Hospital</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>
      Purpose to evaluate the effects of buccal misoprostol with or without intravenous tranexamic&#xD;
      acid (TA) in comparison with placebo on reducing post-partum hemorrhage in pregnant women&#xD;
      undergoing emergent cesarean section&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The American Congress of Obstetricians and Gynecologists (ACOG) defines postpartum hemorrhage&#xD;
      (PPH) as the loss of more than 1,000 mL after cesarean delivery. In the majority of cases,&#xD;
      uterine atony is responsible for the occurrence of excessive bleeding during or following&#xD;
      childbirth. The Millennium Development Goal of reducing the maternal mortality ratio by 75 %&#xD;
      by 2015 will remain beyond the investigator reach unless prioritize the prevention and&#xD;
      treatment of PPH in low-resource countries. Consequently, the administration of uterotonic&#xD;
      drugs during cesarean section (CS) has become essential to diminish the risk of PPH and&#xD;
      improve maternal safety. Misoprostol is a prostaglandin E1 analog proven in several&#xD;
      randomized controlled trials to be effective in preventing PPH because of its strong&#xD;
      uterotonic effects. In addition, misoprostol is inexpensive, stable at room temperature, and&#xD;
      easy to administer. Misoprostol has been broadly studied in the prevention and treatment of&#xD;
      PPH after vaginal delivery; however, its use in conjunction with CS has not been investigated&#xD;
      as much.T he buccal route is recognized as having the greatest benefit due to its rapid&#xD;
      uptake, long-acting effect, and greatest bioavailability compared with other routes of&#xD;
      misoprostol administration. Anti-fibrinolytic agents, such as tranexamic acid (TA), reduce&#xD;
      the risk of death in bleeding trauma patients. On the other hand, it has been suggested that&#xD;
      TA administration reduces blood loss and the incidence of PPH in females after vaginal or&#xD;
      elective CS. The investigators designed this study to evaluate and compare these two new&#xD;
      therapeutic options in controlling PPH following emergent CS.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 1, 2019</start_date>
  <completion_date type="Anticipated">January 31, 2021</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2020</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>
    <intervention_model_description>A Double-Blind Randomized Clinical Trial</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>a double-blinded randomized placebo-controlled trial</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>estimation of intraoperative blood loss (ml)</measure>
    <time_frame>during the operation</time_frame>
    <description>measure Intraoperative blood loss in ml by gravimetric methods</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>amount of postoperative blood loss</measure>
    <time_frame>6 hours post operative</time_frame>
    <description>measure amount of blood loss post operative in ml by gravimetric methods</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>number of patient with postpartum hemorrhage</measure>
    <time_frame>24 hours post operative</time_frame>
    <description>calculation of the number of the patients with blood loss &gt;1000 ml</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Cesarean Section Complications</condition>
  <arm_group>
    <arm_group_label>Misoprostol with TA</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>400 μg of buccal misoprostol (two tablets) plus 1 gm tranexamic acid in 100 ml saline by iv rout</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Misoprostol with placebo to TA</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>400 μg of buccal misoprostol (two tablets) plus 110 ml saline by iv rout</description>
  </arm_group>
  <arm_group>
    <arm_group_label>placebo to Misoprostol and TA</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>placebo to misoprostol plus placebo to tranexamic acid</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Misoprostol</intervention_name>
    <description>400 μg of buccal misoprostol</description>
    <arm_group_label>Misoprostol with TA</arm_group_label>
    <arm_group_label>Misoprostol with placebo to TA</arm_group_label>
    <other_name>Active Comparator</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>TA</intervention_name>
    <description>1 gm of tranexamic acid in 100 ml saline iv</description>
    <arm_group_label>Misoprostol with TA</arm_group_label>
    <arm_group_label>placebo to Misoprostol and TA</arm_group_label>
    <other_name>active comparator</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>placebo to misoprostol</intervention_name>
    <description>placebo tablets to misoprostol buccal</description>
    <arm_group_label>placebo to Misoprostol and TA</arm_group_label>
    <other_name>Placebo comparator</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>placebo to TA</intervention_name>
    <description>110 ml saline iv</description>
    <arm_group_label>Misoprostol with placebo to TA</arm_group_label>
    <other_name>placebo comparator</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age &gt;18 years, singleton pregnancy, term gestation and decision made for a cesarean&#xD;
             section in labor&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  multiple gestations&#xD;
&#xD;
          -  placenta praevia and placental abruption&#xD;
&#xD;
          -  undergoing cesarean section with general anesthesia&#xD;
&#xD;
          -  women undergoing cesarean section at less than 37 weeks of gestation--with a severe&#xD;
             medical disorder&#xD;
&#xD;
          -  allergy to tranexamic acid or misoprostol&#xD;
&#xD;
          -  refuse to consent&#xD;
&#xD;
          -  elective cesarean section&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>age &gt;18 years, singleton pregnancy, term gestation and decision made for a cesarean section in labor</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>hany f sallam, md</last_name>
    <role>Principal Investigator</role>
    <affiliation>Aswan University Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>hany f sallam, md</last_name>
    <phone>01022336052</phone>
    <email>hany.farouk@aswu.edu.eg</email>
  </overall_contact>
  <location>
    <facility>
      <name>Aswan University</name>
      <address>
        <city>Aswan</city>
        <zip>81528</zip>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>hany f sallam, md</last_name>
      <phone>01092440504</phone>
      <phone_ext>002</phone_ext>
      <email>nahla.elsayed@aswu.ed.eg</email>
    </contact>
    <contact_backup>
      <last_name>Nahla w Shady, md</last_name>
      <phone>1019240504</phone>
      <phone_ext>002</phone_ext>
      <email>nahla.elsayed@aswu.edu.eg</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>December 14, 2018</study_first_submitted>
  <study_first_submitted_qc>December 14, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 17, 2018</study_first_posted>
  <last_update_submitted>February 14, 2019</last_update_submitted>
  <last_update_submitted_qc>February 14, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 18, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Aswan University Hospital</investigator_affiliation>
    <investigator_full_name>hany farouk</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>cesarean section</keyword>
  <keyword>tranexamic acid</keyword>
  <keyword>postpartum hemorrhage</keyword>
  <keyword>misoprostol</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Postpartum Hemorrhage</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Misoprostol</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03777696
org study id: aswu /185/18
nct id: NCT03777696
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Purpose to evaluate the effects of buccal misoprostol with or without intravenous tranexamic
      acid (TA) in comparison with placebo on reducing post-partum hemorrhage in pregnant women
      undergoing emergent cesarean section
The American Congress of Obstetricians and Gynecologists (ACOG) defines postpartum hemorrhage
      (PPH) as the loss of more than 1,000 mL after cesarean delivery. In the majority of cases,
      uterine atony is responsible for the occurrence of excessive bleeding during or following
      childbirth. The Millennium Development Goal of reducing the maternal mortality ratio by 75 %
      by 2015 will remain beyond the investigator reach unless prioritize the prevention and
      treatment of PPH in low-resource countries. Consequently, the administration of uterotonic
      drugs during cesarean section (CS) has become essential to diminish the risk of PPH and
      improve maternal safety. Misoprostol is a prostaglandin E1 analog proven in several
      randomized controlled trials to be effective in preventing PPH because of its strong
      uterotonic effects. In addition, misoprostol is inexpensive, stable at room temperature, and
      easy to administer. Misoprostol has been broadly studied in the prevention and treatment of
      PPH after vaginal delivery; however, its use in conjunction with CS has not been investigated
      as much.T he buccal route is recognized as having the greatest benefit due to its rapid
      uptake, long-acting effect, and greatest bioavailability compared with other routes of
      misoprostol administration. Anti-fibrinolytic agents, such as tranexamic acid (TA), reduce
      the risk of death in bleeding trauma patients. On the other hand, it has been suggested that
      TA administration reduces blood loss and the incidence of PPH in females after vaginal or
      elective CS. The investigators designed this study to evaluate and compare these two new
      therapeutic options in controlling PPH following emergent CS.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: A Double-Blind Randomized Clinical Trial
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: a double-blinded randomized placebo-controlled trial
measure: estimation of intraoperative blood loss (ml)
time frame: during the operation
description: measure Intraoperative blood loss in ml by gravimetric methods
measure: amount of postoperative blood loss
time frame: 6 hours post operative
description: measure amount of blood loss post operative in ml by gravimetric methods
measure: number of patient with postpartum hemorrhage
time frame: 24 hours post operative
description: calculation of the number of the patients with blood loss >1000 ml
arm group label: Misoprostol with TA
arm group type: Active Comparator
description: 400 μg of buccal misoprostol (two tablets) plus 1 gm tranexamic acid in 100 ml saline by iv rout
arm group label: Misoprostol with placebo to TA
arm group type: Active Comparator
description: 400 μg of buccal misoprostol (two tablets) plus 110 ml saline by iv rout
arm group label: placebo to Misoprostol and TA
arm group type: Placebo Comparator
description: placebo to misoprostol plus placebo to tranexamic acid
intervention type: Drug
intervention name: Misoprostol
description: 400 μg of buccal misoprostol
arm group label: Misoprostol with TA
arm group label: Misoprostol with placebo to TA
other name: Active Comparator
intervention type: Drug
intervention name: TA
description: 1 gm of tranexamic acid in 100 ml saline iv
arm group label: Misoprostol with TA
arm group label: placebo to Misoprostol and TA
other name: active comparator
intervention type: Drug
intervention name: placebo to misoprostol
description: placebo tablets to misoprostol buccal
arm group label: placebo to Misoprostol and TA
other name: Placebo comparator
intervention type: Drug
intervention name: placebo to TA
description: 110 ml saline iv
arm group label: Misoprostol with placebo to TA
other name: placebo comparator
criteria: 
gender: Female
gender based: Yes
gender description: age >18 years, singleton pregnancy, term gestation and decision made for a cesarean section in labor
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: No
last name: hany f sallam, md
role: Principal Investigator
affiliation: Aswan University Hospital
last name: hany f sallam, md
phone: 01022336052
email: hany.farouk@aswu.edu.eg
facility: 
status: Recruiting
contact: 
contact backup: 
country: Egypt
responsible party type: Sponsor-Investigator
investigator affiliation: Aswan University Hospital
investigator full name: hany farouk
investigator title: Principal Investigator
mesh term: Postpartum Hemorrhage
mesh term: Misoprostol
sharing ipd: Undecided