<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/NCT02185625</url>
  </required_header>
  <id_info>
    <org_study_id>AU201407</org_study_id>
    <secondary_id>AU201407</secondary_id>
    <nct_id>NCT02185625</nct_id>
  </id_info>
  <brief_title>Reduction of Adverse Pregnancy Outcomes With a Smartphone Application in Ghana</brief_title>
  <official_title>Reduction of Adverse Pregnancy Outcomes With a Smartphone Application in Ghana: a Cluster Randomized Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Aarhus</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Copenhagen</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Ghana</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Maternity Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Augustinus Fonden</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Lundbeck Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Edith and Godtfred Kirk Christiansen Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Aase and Ejnar Danielsens Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Aarhus</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine whether use of the Safe Delivery smartphone&#xD;
      application by midwives can reduce excess blood loss from bleeding, and infant death during&#xD;
      childbirth in Ghanaian women. Moreover, it will be investigated whether the Safe Delivery&#xD;
      application can increase midwives' knowledge and skills in managing childbirth.&#xD;
&#xD;
      Fifteen hospitals in Greater Accra, Ghana, will be cluster randomized to either use the Safe&#xD;
      Delivery application (intervention), or to no intervention (control). In the intervention&#xD;
      hospitals, midwives will be educated in the use of Safe Delivery. Pregnant women will be&#xD;
      enrolled at delivery and followed until 7 days postpartum. Data collection will begin July&#xD;
      2014 and is expected to be finished by October 2014.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">September 2014</completion_date>
  <primary_completion_date type="Actual">September 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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Postpartum Hemorrhage.</measure>
    <time_frame>Measurements 2 hours after delivery.</time_frame>
    <description>Postpartum Hemorrhage is defined as blood loss greater than 500 ml from bleeding associated with childbirth within first 2 hours postpartum.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Blood loss</measure>
    <time_frame>Measurements 2 hours after delivery.</time_frame>
    <description>Amount of blood loss (ml) from bleeding associated with childbirth within first 2 hours postpartum.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Key feature questionnaire (KFQ).</measure>
    <time_frame>At baseline and 2 months after randomization.</time_frame>
    <description>The KFQ questionnaire measures midwives' knowledge in relation to 1) active management of the third stage of labour, 2) treatment of postpartum hemorrhage, 3) manual removal of placenta, and 4) neonatal resuscitation. The midwives' performance will be scored by research assistants by use of the KFQ tool.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Objective structured assessment of technical skill (OSATS).</measure>
    <time_frame>At baseline and 2 months after randomization.</time_frame>
    <description>The OSATS tool measures midwives' skills in relation to 1) active management of the third stage of labour, 2) treatment of postpartum hemorrhage, 3) manual removal of placenta, and 4) neonatal resuscitation. The midwives' performance will be scored by research assistants by use of the OSATS tool.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fresh stillbirth</measure>
    <time_frame>At delivery.</time_frame>
    <description>Delivery of a fetus with a birth weight above 1,000 g birth weight who at birth has no signs of life (breathing, crying or movement) with intact skin.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neonatal mortality 7 days postpartum.</measure>
    <time_frame>Within 7 days postpartum.</time_frame>
    <description>A baby born alive with a birth weight above 1000 g who dies within 7 days postpartum.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">3773</enrollment>
  <condition>Postpartum Hemorrhage</condition>
  <condition>Delivery, Obstetric</condition>
  <condition>Stillbirth</condition>
  <condition>Infant Mortality</condition>
  <condition>Midwifery</condition>
  <arm_group>
    <arm_group_label>Safe Delivery smartphone application</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Safe Delivery smartphone application</intervention_name>
    <description>The intervention is the use of a smartphone application called Safe Delivery, designed by University of Copenhagen, Denmark and Maternity Foundation Denmark. The application contains animated videos aimed to train midwives in the prevention and management of postpartum hemorrhage and the treatment of neonatal resuscitation. The instructions in the videos are based on WHO recommendations, and the application is designed to be an on-going tool for midwives, so that they can drill themselves in the emergencies of postpartum hemorrhage and neonatal resuscitation.</description>
    <arm_group_label>Safe Delivery smartphone application</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria for Hospitals:&#xD;
&#xD;
          -  Located in the region of Greater Accra.&#xD;
&#xD;
          -  The hospital should have at least 10 midwives employed.&#xD;
&#xD;
          -  The patient flow for each midwife should be at least 10 deliveries per month.&#xD;
&#xD;
          -  The annual average number of deliveries should be at least 1,200.&#xD;
&#xD;
        Inclusion criteria for midwives:&#xD;
&#xD;
          -  Should have no leave or vacation from June 17th to September 17th 2014.&#xD;
&#xD;
          -  Should have a full time employment at the delivery ward (conducting deliveries 100% of&#xD;
             the work time).&#xD;
&#xD;
          -  Should be willing and available to participate in an information meeting at the&#xD;
             hospital where the balloting among eligible midwives will take place.&#xD;
&#xD;
          -  Should give an informed consent to participate in the study.&#xD;
&#xD;
          -  Should be willing and available to participate in a workshop July 14th 2014 (this is&#xD;
             the day of randomization, and intervention midwives will receive smartphone training).&#xD;
&#xD;
          -  Should be willing and available to participate in a workshop September 17th 2014 (to&#xD;
             complete an end of study questionnaire, the key feature questionnaire, and control&#xD;
             midwives will receive smartphones).&#xD;
&#xD;
          -  Should be proficient in English to understand the spoken instructions in the animated&#xD;
             videos.&#xD;
&#xD;
        Inclusion criteria for women in labor:&#xD;
&#xD;
          -  Should be in active labor.&#xD;
&#xD;
          -  Should give informed consent to participate in the study.&#xD;
&#xD;
          -  Should give birth vaginally.&#xD;
&#xD;
        The women in labor and their newborn children will be the primary observational units.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Christina MB Nielsen, BSc, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Public Health, Aarhus University, Denmark</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Achimota Hospital</name>
      <address>
        <city>Accra</city>
        <country>Ghana</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ashaiman Polyclinic</name>
      <address>
        <city>Accra</city>
        <country>Ghana</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ga South Municipal Hospital</name>
      <address>
        <city>Accra</city>
        <country>Ghana</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ga West Municipal Hospital</name>
      <address>
        <city>Accra</city>
        <country>Ghana</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Keneshi Polyclinic</name>
      <address>
        <city>Accra</city>
        <country>Ghana</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>La General Hospital</name>
      <address>
        <city>Accra</city>
        <country>Ghana</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lekma Hospital</name>
      <address>
        <city>Accra</city>
        <country>Ghana</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Maamobi General Hospital</name>
      <address>
        <city>Accra</city>
        <country>Ghana</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Madina Polyclinic</name>
      <address>
        <city>Accra</city>
        <country>Ghana</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mamprobi Polyclinic</name>
      <address>
        <city>Accra</city>
        <country>Ghana</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ridge Hospital</name>
      <address>
        <city>Accra</city>
        <country>Ghana</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shai Osu Doku District Hospital</name>
      <address>
        <city>Accra</city>
        <country>Ghana</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tema General Hospital</name>
      <address>
        <city>Accra</city>
        <country>Ghana</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tema Polyclinic</name>
      <address>
        <city>Accra</city>
        <country>Ghana</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Usher Poly (James Town Maternity Home)</name>
      <address>
        <city>Accra</city>
        <country>Ghana</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Ghana</country>
  </location_countries>
  <verification_date>July 2015</verification_date>
  <study_first_submitted>July 1, 2014</study_first_submitted>
  <study_first_submitted_qc>July 3, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 9, 2014</study_first_posted>
  <last_update_submitted>May 18, 2016</last_update_submitted>
  <last_update_submitted_qc>May 18, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 19, 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>Stillbirth</mesh_term>
    <mesh_term>Hemorrhage</mesh_term>
    <mesh_term>Infant Death</mesh_term>
  </condition_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/NCT02185625
org study id: AU201407
secondary id: AU201407
nct id: NCT02185625
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
The purpose of this study is to determine whether use of the Safe Delivery smartphone
      application by midwives can reduce excess blood loss from bleeding, and infant death during
      childbirth in Ghanaian women. Moreover, it will be investigated whether the Safe Delivery
      application can increase midwives' knowledge and skills in managing childbirth.

      Fifteen hospitals in Greater Accra, Ghana, will be cluster randomized to either use the Safe
      Delivery application (intervention), or to no intervention (control). In the intervention
      hospitals, midwives will be educated in the use of Safe Delivery. Pregnant women will be
      enrolled at delivery and followed until 7 days postpartum. Data collection will begin July
      2014 and is expected to be finished by October 2014.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Postpartum Hemorrhage.
time frame: Measurements 2 hours after delivery.
description: Postpartum Hemorrhage is defined as blood loss greater than 500 ml from bleeding associated with childbirth within first 2 hours postpartum.
measure: Blood loss
time frame: Measurements 2 hours after delivery.
description: Amount of blood loss (ml) from bleeding associated with childbirth within first 2 hours postpartum.
measure: Key feature questionnaire (KFQ).
time frame: At baseline and 2 months after randomization.
description: The KFQ questionnaire measures midwives' knowledge in relation to 1) active management of the third stage of labour, 2) treatment of postpartum hemorrhage, 3) manual removal of placenta, and 4) neonatal resuscitation. The midwives' performance will be scored by research assistants by use of the KFQ tool.
measure: Objective structured assessment of technical skill (OSATS).
time frame: At baseline and 2 months after randomization.
description: The OSATS tool measures midwives' skills in relation to 1) active management of the third stage of labour, 2) treatment of postpartum hemorrhage, 3) manual removal of placenta, and 4) neonatal resuscitation. The midwives' performance will be scored by research assistants by use of the OSATS tool.
measure: Fresh stillbirth
time frame: At delivery.
description: Delivery of a fetus with a birth weight above 1,000 g birth weight who at birth has no signs of life (breathing, crying or movement) with intact skin.
measure: Neonatal mortality 7 days postpartum.
time frame: Within 7 days postpartum.
description: A baby born alive with a birth weight above 1000 g who dies within 7 days postpartum.
arm group label: Safe Delivery smartphone application
arm group type: Experimental
arm group label: Control
arm group type: No Intervention
intervention type: Device
intervention name: Safe Delivery smartphone application
description: The intervention is the use of a smartphone application called Safe Delivery, designed by University of Copenhagen, Denmark and Maternity Foundation Denmark. The application contains animated videos aimed to train midwives in the prevention and management of postpartum hemorrhage and the treatment of neonatal resuscitation. The instructions in the videos are based on WHO recommendations, and the application is designed to be an on-going tool for midwives, so that they can drill themselves in the emergencies of postpartum hemorrhage and neonatal resuscitation.
arm group label: Safe Delivery smartphone application
criteria: 
gender: Female
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Christina MB Nielsen, BSc, MPH
role: Principal Investigator
affiliation: Department of Public Health, Aarhus University, Denmark
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Ghana
responsible party type: Sponsor
mesh term: Postpartum Hemorrhage
mesh term: Stillbirth
mesh term: Hemorrhage
mesh term: Infant Death