<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/NCT01713153</url>
  </required_header>
  <id_info>
    <org_study_id>2.4.9</org_study_id>
    <nct_id>NCT01713153</nct_id>
  </id_info>
  <brief_title>Comparing Misoprostol and Oxytocin in Uniject for Postpartum Hemorrhage (PPH) Prevention in Senegal</brief_title>
  <official_title>Preventing Postpartum Hemorrhage: Examining Two Strategies for PPH Prevention in Communities: Misoprostol and Oxytocin Uniject in Senegal</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Gynuity Health Projects</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>ChildFund International</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Gynuity Health Projects</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a large, community-based, cluster-randomized trial to compare routine prophylactic&#xD;
      use of 600 mcg oral misoprostol and 10 IU oxytocin delivered by UnijectTM intramuscularly&#xD;
      during the third stage of labor&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will assess the programmatic implications (including feasibility, acceptability,&#xD;
      risks and benefits) at the community level of the introduction of misoprostol and/or oxytocin&#xD;
      in UnijectTM for the prevention of PPH and will help to identify the appropriate niche for&#xD;
      both drugs.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2012</start_date>
  <completion_date type="Actual">January 2014</completion_date>
  <primary_completion_date type="Actual">January 2014</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mean change in hemoglobin</measure>
    <time_frame>during 3rd trimester and 1-3 days postpartum</time_frame>
    <description>To establish the comparable effectiveness of two technologies, individual pre- and post-delivery Hb measures will be taken to calculate change in Hb. This will be done using a Hemocue Hemoglobin machine + cuvette (HemoCue, Angelholm, Sweden). The Hemocue is a simple means of collecting Hb measures at the community-level where traditional laboratory techniques are not feasible</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Occurrence and management of side effects</measure>
    <time_frame>1 hour postpartum</time_frame>
    <description>nausea, vomiting, diarrhea, shivering, fever</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>correct timing of drug administration</measure>
    <time_frame>collected immediately following birth, verified 1-3 days postpartum</time_frame>
    <description>administration of the drug after the birth of the baby and verifying no twin, before the expulsion of the placenta</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change in hemoglobin ≥ 2 g/dL</measure>
    <time_frame>during third trimester and 1-3 days postpartum</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>additional interventions</measure>
    <time_frame>during birth</time_frame>
    <description>use of additional uterotonics, manual removal of placental fragments, etc</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>referrals</measure>
    <time_frame>0-3 days postpartum</time_frame>
    <description>referral requested, transfers carried out, reasons for incomplete referrals/transfers</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>acceptability</measure>
    <time_frame>1-3 days postpartum</time_frame>
    <description>acceptability according to woman of study medication, care received, side effects experienced</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1365</enrollment>
  <condition>Postpartum Hemorrhage</condition>
  <arm_group>
    <arm_group_label>Misoprostol</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>600 mcg oral misoprostol administered during the third stage of labor</description>
  </arm_group>
  <arm_group>
    <arm_group_label>UnijectTM</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>10 IU oxytocin delivered IM with UnijectTM during he third stage of labor</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Misoprostol</intervention_name>
    <description>600 mcg misoprostol oral</description>
    <arm_group_label>Misoprostol</arm_group_label>
    <other_name>Cytotec</other_name>
    <other_name>Misoclear</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>UnijectTM</intervention_name>
    <description>10 IU oxytocin delivered intramuscularly with UnijectTM</description>
    <arm_group_label>UnijectTM</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  women delivering in community health centers (case de sante) with a trained study&#xD;
             provider (matrone) who are able to provide informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  women with known contraindications to prostaglandins&#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>
  <location>
    <facility>
      <name>Health huts in the district of Thiadiaye and Kolda</name>
      <address>
        <city>Thiadiay and Kolda</city>
        <state>Thiadiaye and Kolda</state>
        <country>Senegal</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Senegal</country>
  </location_countries>
  <verification_date>February 2016</verification_date>
  <study_first_submitted>October 22, 2012</study_first_submitted>
  <study_first_submitted_qc>October 22, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 24, 2012</study_first_posted>
  <last_update_submitted>February 24, 2016</last_update_submitted>
  <last_update_submitted_qc>February 24, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 25, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>postpartum hemorrhage</keyword>
  <keyword>prevention</keyword>
  <keyword>misoprostol</keyword>
  <keyword>Uniject</keyword>
  <keyword>oxytocin</keyword>
  <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/NCT01713153
org study id: 2.4.9
nct id: NCT01713153
lead sponsor: 
collaborator: 
has dmc: Yes
This is a large, community-based, cluster-randomized trial to compare routine prophylactic
      use of 600 mcg oral misoprostol and 10 IU oxytocin delivered by UnijectTM intramuscularly
      during the third stage of labor
This study will assess the programmatic implications (including feasibility, acceptability,
      risks and benefits) at the community level of the introduction of misoprostol and/or oxytocin
      in UnijectTM for the prevention of PPH and will help to identify the appropriate niche for
      both drugs.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Mean change in hemoglobin
time frame: during 3rd trimester and 1-3 days postpartum
description: To establish the comparable effectiveness of two technologies, individual pre- and post-delivery Hb measures will be taken to calculate change in Hb. This will be done using a Hemocue Hemoglobin machine + cuvette (HemoCue, Angelholm, Sweden). The Hemocue is a simple means of collecting Hb measures at the community-level where traditional laboratory techniques are not feasible
measure: Occurrence and management of side effects
time frame: 1 hour postpartum
description: nausea, vomiting, diarrhea, shivering, fever
measure: correct timing of drug administration
time frame: collected immediately following birth, verified 1-3 days postpartum
description: administration of the drug after the birth of the baby and verifying no twin, before the expulsion of the placenta
measure: change in hemoglobin ≥ 2 g/dL
time frame: during third trimester and 1-3 days postpartum
measure: additional interventions
time frame: during birth
description: use of additional uterotonics, manual removal of placental fragments, etc
measure: referrals
time frame: 0-3 days postpartum
description: referral requested, transfers carried out, reasons for incomplete referrals/transfers
measure: acceptability
time frame: 1-3 days postpartum
description: acceptability according to woman of study medication, care received, side effects experienced
arm group label: Misoprostol
arm group type: Experimental
description: 600 mcg oral misoprostol administered during the third stage of labor
arm group label: UnijectTM
arm group type: Experimental
description: 10 IU oxytocin delivered IM with UnijectTM during he third stage of labor
intervention type: Drug
intervention name: Misoprostol
description: 600 mcg misoprostol oral
arm group label: Misoprostol
other name: Cytotec
other name: Misoclear
intervention type: Device
intervention name: UnijectTM
description: 10 IU oxytocin delivered intramuscularly with UnijectTM
arm group label: UnijectTM
criteria: 
gender: Female
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Senegal
responsible party type: Sponsor
mesh term: Postpartum Hemorrhage
mesh term: Hemorrhage
mesh term: Misoprostol