<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/NCT03774524</url>
  </required_header>
  <id_info>
    <org_study_id>aswu / 183/18</org_study_id>
    <nct_id>NCT03774524</nct_id>
  </id_info>
  <brief_title>Sublingual Misoprostol and Tranexamic Acid in Pregnant Women With Twin Pregnancy Undergoing Cesarean Section</brief_title>
  <official_title>Effects of Co-administered Sublingual Misoprostol and Intravenous Tranexamic Acid on Prevention of Postpartum Hemorrhage in Pregnant Women With Twin Pregnancy Undergoing Elective Cesarean Section: A Double-Blind Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Aswan University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Aswan University Hospital</source>
  <oversight_info>
    <has_dmc>No</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 sublingual misoprostol with or without intravenous&#xD;
      tranexamic acid (TA) in comparison with placebo on reducing post-partum hemorrhage in&#xD;
      pregnant women with twin pregnancy undergoing an elective cesarean section.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Uterine atony is the major cause of postpartum hemorrhage (PPH), accounting for up to 80% of&#xD;
      PPH cases. PPH is the leading cause of maternal morbidity and mortality worldwide, resulting&#xD;
      in up to 28% of maternal deaths. Therefore, inducing a rapid and effective uterine&#xD;
      contraction following delivery is an important issue. Risk factors of uterine atony include&#xD;
      obesity, White or Hispanic race/ethnicity, polyhydramnios, preeclampsia, anemia, and&#xD;
      chorioamnionitis as well as a twin pregnancy.&#xD;
&#xD;
      With the increasingly common use of ovulation induction and assisted reproduction techniques,&#xD;
      the incidence of multiple gestation pregnancies has progressively increased. Suzuki et al&#xD;
      reported that elective cesarean delivery of twin pregnancy at a gestational age of 37 weeks&#xD;
      or greater may increase the risk of blood transfusion. Several uterotonic agents are used to&#xD;
      prevent PPH because of uterine atony, including oxytocin, an ergot alkaloid, and&#xD;
      prostaglandin. However, there are currently no data to evaluate the efficacy of&#xD;
      co-administered Sublingual Misoprostol and Intravenous Tranexamic Acid on prevention of&#xD;
      postpartum hemorrhage in pregnant women with twin pregnancy undergoing an elective cesarean.&#xD;
      therefore, this study was designed to evaluate and compare these two new therapeutic options&#xD;
      in controlling PPH following CS for twin pregnancy&#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">March 1, 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">150</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 sublingual 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 sublingual misoprostol (two tablets) plus 110 ml saline by iv rout</description>
  </arm_group>
  <arm_group>
    <arm_group_label>placebo to Misoprostol with placebo to 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 sublingual 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>
    <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 subligual</description>
    <arm_group_label>Misoprostol with placebo to TA</arm_group_label>
    <arm_group_label>placebo to Misoprostol with placebo to 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>placebo to Misoprostol with placebo to TA</arm_group_label>
    <other_name>placebo comparator</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  women with a multiple term pregnancy undergoing elective cesarean section&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  single gestation&#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&#xD;
&#xD;
          -  with a severe medical disorder&#xD;
&#xD;
          -  allergy to tranexamic acid or misoprostol&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>women with a multiple term pregnancy undergoing elective cesarean section</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>
    <phone_ext>002</phone_ext>
    <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 12, 2018</study_first_submitted>
  <study_first_submitted_qc>December 12, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 13, 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 15, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal 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/NCT03774524
org study id: aswu / 183/18
nct id: NCT03774524
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Purpose to evaluate the effects of sublingual misoprostol with or without intravenous
      tranexamic acid (TA) in comparison with placebo on reducing post-partum hemorrhage in
      pregnant women with twin pregnancy undergoing an elective cesarean section.
Uterine atony is the major cause of postpartum hemorrhage (PPH), accounting for up to 80% of
      PPH cases. PPH is the leading cause of maternal morbidity and mortality worldwide, resulting
      in up to 28% of maternal deaths. Therefore, inducing a rapid and effective uterine
      contraction following delivery is an important issue. Risk factors of uterine atony include
      obesity, White or Hispanic race/ethnicity, polyhydramnios, preeclampsia, anemia, and
      chorioamnionitis as well as a twin pregnancy.

      With the increasingly common use of ovulation induction and assisted reproduction techniques,
      the incidence of multiple gestation pregnancies has progressively increased. Suzuki et al
      reported that elective cesarean delivery of twin pregnancy at a gestational age of 37 weeks
      or greater may increase the risk of blood transfusion. Several uterotonic agents are used to
      prevent PPH because of uterine atony, including oxytocin, an ergot alkaloid, and
      prostaglandin. However, there are currently no data to evaluate the efficacy of
      co-administered Sublingual Misoprostol and Intravenous Tranexamic Acid on prevention of
      postpartum hemorrhage in pregnant women with twin pregnancy undergoing an elective cesarean.
      therefore, this study was designed to evaluate and compare these two new therapeutic options
      in controlling PPH following CS for twin pregnancy
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 sublingual 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 sublingual misoprostol (two tablets) plus 110 ml saline by iv rout
arm group label: placebo to Misoprostol with placebo to 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 sublingual 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
other name: Active Comparator
intervention type: Drug
intervention name: placebo to misoprostol
description: placebo tablets to misoprostol subligual
arm group label: Misoprostol with placebo to TA
arm group label: placebo to Misoprostol with placebo to TA
other name: Placebo comparator
intervention type: Drug
intervention name: placebo to TA
description: 110 ml saline iv
arm group label: placebo to Misoprostol with placebo to TA
other name: placebo comparator
criteria: 
gender: Female
gender based: Yes
gender description: women with a multiple term pregnancy undergoing elective cesarean section
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
phone ext: 002
email: hany.farouk@aswu.edu.eg
facility: 
status: Recruiting
contact: 
contact backup: 
country: Egypt
responsible party type: Principal 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