<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/NCT02226588</url>
  </required_header>
  <id_info>
    <org_study_id>3004</org_study_id>
    <nct_id>NCT02226588</nct_id>
  </id_info>
  <brief_title>Comparison of Primary and Secondary Prevention of Postpartum Hemorrhage at the Community Level in Egypt</brief_title>
  <official_title>Two Community Strategies Comparing Use of Misoprostol for Secondary Prevention to Primary Prevention for Postpartum Hemorrhage: A Randomized Cluster Non-Inferiority Study in El Beheira Governorate, Egypt</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Gynuity Health Projects</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ministry of Health and Population, Egypt</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Alexandria</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>El Galaa Teaching Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Gynuity Health Projects</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this study is to compare two community-level strategies: either selective,&#xD;
      early administration of 800 mcg sublingual misoprostol to women for secondary prevention of&#xD;
      postpartum hemorrhage (PPH) or universal use of 600 mcg oral misoprostol at the time of&#xD;
      delivery for prophylaxis of PPH. The significance of this cluster randomized non-inferiority&#xD;
      trial is its potential to inform service delivery programs on clinical outcomes, program&#xD;
      feasibility, cost, and acceptability of two different community models of PPH care using&#xD;
      misoprostol.1. The study hypothesizes that a service delivery model that administers&#xD;
      misoprostol for secondary prevention is non-inferior to a model that administers misoprostol&#xD;
      for universal prophylaxis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">January 2016</completion_date>
  <primary_completion_date type="Actual">January 2016</primary_completion_date>
  <phase>Phase 4</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mean drop in pre- to post-delivery hemoglobin level</measure>
    <time_frame>Pre-delivery hemoglobin will be measured during a third trimester antenatal care visit or during early labor. Post-delivery hemoglbin will be measured 2 to 4 days after delivery of the baby.</time_frame>
    <description>Hemoglobin will be measured by primary health unit staff using a portable handheld Hemocue machine.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Proportion of women transferred to higher level care</measure>
    <time_frame>Following delivery to postpartum visit (2 to 4 days after delivery)</time_frame>
    <description>The proportion of women transferred to higher level care will be assessed. Includes the condition of woman at time of transfer and arrival at transfer facility.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of women diagnosed with PPH</measure>
    <time_frame>After delivery of the baby up to 24 hours postpartum</time_frame>
    <description>PPH will be diagnosed using the standard practices of PHU staff</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of women receiving additional interventions for PPH</measure>
    <time_frame>Following delivery to postpartum visit (2 to 4 days after delivery)</time_frame>
    <description>An additional intervention could include: uterotonics, manual removal of placental fragments. bimanual compression, IV fluids given to control active bleeding.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of women who experience side effects</measure>
    <time_frame>From time of delivery to 2 hours postpartum</time_frame>
    <description>Women experiencing known side effects of misoprostol, including shivering/chills and pyrexia; severity, duration, and any additional care provided will be assessed</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of women who find the intervention acceptable</measure>
    <time_frame>Measured at postpartum visit (2 to 4 days after delivery)</time_frame>
    <description>Acceptability will be assessed in an exit interview with women - women will be asked if they are willing to take misoprostol in future deliveries and about the preferences what method they would prefer (primary or secondary prevention) in future deliveries.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of women who receive intervention per protocol</measure>
    <time_frame>within 2 hours of delivery</time_frame>
    <description>To assess feasibility, we will document the proportion of women for whom the intervention arm protocol is correctly followed (including correct timing of drug administration, when necessary).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of women experiencing a serious adverse event</measure>
    <time_frame>Within 2 to 4 days after delivery</time_frame>
    <description>Serious adverse events include hysterectomy, blood transfusion, maternal death</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">2827</enrollment>
  <condition>Postpartum Hemorrhage</condition>
  <arm_group>
    <arm_group_label>Secondary prevention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single sublingual dose of 800mcg (4 tablets) misoprostol administered to women with 350-500mL postpartum blood loss as estimated using a blood absorption mat or due to deteriorating postpartum condition of the woman as determined by provider's clinical judgment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Universal prophylaxis</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Single oral prophylactic dose of 600mcg (3 tablets) misoprostol administered to all women within 1 minute of deliver of baby</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Misoprostol</intervention_name>
    <arm_group_label>Secondary prevention</arm_group_label>
    <arm_group_label>Universal prophylaxis</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Willing and able to give informed consent&#xD;
&#xD;
          -  Vaginal delivery&#xD;
&#xD;
          -  Agrees to participate in follow-up interview&#xD;
&#xD;
          -  Agrees to have pre- and post-hemoglobin taken&#xD;
&#xD;
          -  Delivery at woman's home or at the primary health unit (PHU)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Too advanced into active labor to provide consent&#xD;
&#xD;
          -  Known allergy to misoprostol and/or other prostaglandin&#xD;
&#xD;
          -  Pregnancy complications, such as hypertension, suspected multiple pregnancy, previous&#xD;
             caesarean section, suspected still birth, ante-partum hemorrhage, and previous&#xD;
             complication in the third trimester&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nevine Hassanein, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Consultant</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Emad Darwish, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Alexandria University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Mohamed Cherine, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>El Galaa Teaching Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Rasha Dabash, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Gynuity Health Projects</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Holly Anger, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Gynuity Health Projects</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Primary Health Care Units</name>
      <address>
        <city>Damanhour</city>
        <state>El Beheira</state>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Primary Health Care Units</name>
      <address>
        <city>Kafr El Dawar</city>
        <state>El Beheira</state>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <link>
    <url>http://www.gynuity.org</url>
    <description>Related Info</description>
  </link>
  <verification_date>February 2016</verification_date>
  <study_first_submitted>August 25, 2014</study_first_submitted>
  <study_first_submitted_qc>August 25, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 27, 2014</study_first_posted>
  <last_update_submitted>February 12, 2016</last_update_submitted>
  <last_update_submitted_qc>February 12, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 15, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </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>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Misoprostol</mesh_term>
  </intervention_browse>
  <!-- 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/NCT02226588
org study id: 3004
nct id: NCT02226588
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
The objective of this study is to compare two community-level strategies: either selective,
      early administration of 800 mcg sublingual misoprostol to women for secondary prevention of
      postpartum hemorrhage (PPH) or universal use of 600 mcg oral misoprostol at the time of
      delivery for prophylaxis of PPH. The significance of this cluster randomized non-inferiority
      trial is its potential to inform service delivery programs on clinical outcomes, program
      feasibility, cost, and acceptability of two different community models of PPH care using
      misoprostol.1. The study hypothesizes that a service delivery model that administers
      misoprostol for secondary prevention is non-inferior to a model that administers misoprostol
      for universal prophylaxis.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Mean drop in pre- to post-delivery hemoglobin level
time frame: Pre-delivery hemoglobin will be measured during a third trimester antenatal care visit or during early labor. Post-delivery hemoglbin will be measured 2 to 4 days after delivery of the baby.
description: Hemoglobin will be measured by primary health unit staff using a portable handheld Hemocue machine.
measure: Proportion of women transferred to higher level care
time frame: Following delivery to postpartum visit (2 to 4 days after delivery)
description: The proportion of women transferred to higher level care will be assessed. Includes the condition of woman at time of transfer and arrival at transfer facility.
measure: Proportion of women diagnosed with PPH
time frame: After delivery of the baby up to 24 hours postpartum
description: PPH will be diagnosed using the standard practices of PHU staff
measure: Proportion of women receiving additional interventions for PPH
time frame: Following delivery to postpartum visit (2 to 4 days after delivery)
description: An additional intervention could include: uterotonics, manual removal of placental fragments. bimanual compression, IV fluids given to control active bleeding.
measure: Proportion of women who experience side effects
time frame: From time of delivery to 2 hours postpartum
description: Women experiencing known side effects of misoprostol, including shivering/chills and pyrexia; severity, duration, and any additional care provided will be assessed
measure: Proportion of women who find the intervention acceptable
time frame: Measured at postpartum visit (2 to 4 days after delivery)
description: Acceptability will be assessed in an exit interview with women - women will be asked if they are willing to take misoprostol in future deliveries and about the preferences what method they would prefer (primary or secondary prevention) in future deliveries.
measure: Proportion of women who receive intervention per protocol
time frame: within 2 hours of delivery
description: To assess feasibility, we will document the proportion of women for whom the intervention arm protocol is correctly followed (including correct timing of drug administration, when necessary).
measure: Proportion of women experiencing a serious adverse event
time frame: Within 2 to 4 days after delivery
description: Serious adverse events include hysterectomy, blood transfusion, maternal death
arm group label: Secondary prevention
arm group type: Experimental
description: Single sublingual dose of 800mcg (4 tablets) misoprostol administered to women with 350-500mL postpartum blood loss as estimated using a blood absorption mat or due to deteriorating postpartum condition of the woman as determined by provider's clinical judgment
arm group label: Universal prophylaxis
arm group type: Active Comparator
description: Single oral prophylactic dose of 600mcg (3 tablets) misoprostol administered to all women within 1 minute of deliver of baby
intervention type: Drug
intervention name: Misoprostol
arm group label: Secondary prevention
arm group label: Universal prophylaxis
criteria: 
gender: Female
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Nevine Hassanein, MD
role: Principal Investigator
affiliation: Consultant
last name: Emad Darwish, MD
role: Principal Investigator
affiliation: Alexandria University
last name: Mohamed Cherine, MD
role: Principal Investigator
affiliation: El Galaa Teaching Hospital
last name: Rasha Dabash, MPH
role: Principal Investigator
affiliation: Gynuity Health Projects
last name: Holly Anger, MPH
role: Principal Investigator
affiliation: Gynuity Health Projects
facility: 
facility: 
country: Egypt
url: http://www.gynuity.org
description: Related Info
responsible party type: Sponsor
mesh term: Postpartum Hemorrhage
mesh term: Hemorrhage
mesh term: Misoprostol