<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/NCT03024905</url>
  </required_header>
  <id_info>
    <org_study_id>108026</org_study_id>
    <nct_id>NCT03024905</nct_id>
  </id_info>
  <brief_title>Project to Use Community Health Workers to Reduce Maternal Deaths</brief_title>
  <acronym>EWH</acronym>
  <official_title>Enhancing All Community Health Workers on Maternal and Newborn Health: Rorya Tanzania</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bruyere Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ottawa Hospital Research Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Shirati KMT Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Bruyere Research Institute</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this trial is to establish if several interventions will help women in rural&#xD;
      Tanzania access health care services during pregnancy and at the time of delivery. The&#xD;
      interventions include education about the importance of attending antenatal care visits with&#xD;
      nurses and facility deliveries, a voucher for transport to access the health facility at the&#xD;
      time of delivery, and supplies to be used either at the health facility, or on route if the&#xD;
      women does not make it to the health facility.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In order to reduce the number of women dying in childbirth and to improve women's health in&#xD;
      pregnancy, this trial is designed to assess if several interventions combined can increase&#xD;
      the number of women delivering in health care facilities. The design of the study is&#xD;
      &quot;Multiple Baseline Design&quot;. Community health workers are trained to collect baseline data on&#xD;
      women using mobile phones in one rural district in Tanzania. The district has four distinct&#xD;
      divisions. After 6 months of baseline data in the district, one division will experience the&#xD;
      interventions. The interventions are education about the importance of attending antenatal&#xD;
      care visits with nurses and facility deliveries, a voucher for transport to access the health&#xD;
      facility at the time of delivery, and birthing supplies to be used either at the health&#xD;
      facility, or on route if the women does not make it to the health facility. The intervention&#xD;
      will be begun in each of the other divisions in 3 month intervals (i.e. the second division&#xD;
      starts to experience the interventions 3 months after the first, the third, 3 months after&#xD;
      the second and the fourth 3 months after the third). The trial will continue for a total of&#xD;
      27 months including the baseline period.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 16, 2017</start_date>
  <completion_date type="Actual">May 2019</completion_date>
  <primary_completion_date type="Actual">May 2019</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>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Facility births</measure>
    <time_frame>During baseline vs during intervention periods until end of study (2 years)</time_frame>
    <description>Number of women attending health facilities for delivery</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Antenatal Care visits</measure>
    <time_frame>During baseline vs during intervention until end of study (2 years)</time_frame>
    <description>Number of times women attend health facility for antenatal visits</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postpartum visits</measure>
    <time_frame>During baseline vs during intervention until end of study (2 years)</time_frame>
    <description>Number of women attending health facility for postpartum visits</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Use of transport intervention</measure>
    <time_frame>During Intervention until end of study (2 years)</time_frame>
    <description>Number of women using the free transport intervention</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Use of birth kit</measure>
    <time_frame>During Intervention until end of study (2 years)</time_frame>
    <description>Number of women using the birth kit</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">17000</enrollment>
  <condition>Maternal Mortality</condition>
  <condition>Access to Health Care</condition>
  <arm_group>
    <arm_group_label>Division 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The first division receives baseline data collection for 6 months then experiences interventions for the remainder of the trial.&#xD;
Interventions are behavioural and device:&#xD;
Behavioural: education about safety of delivery at a health facility, reminders to go for antenatal care, and a voucher for transport to the health facility at the time of delivery.&#xD;
Device: A birth kit with clean delivery supplies (soap, 2 pairs of gloves, cord clamps, surgical blade, and 600 mcg misoprostol for the woman to take immediately after the delivery to prevent postpartum hemorrhage).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Division 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The second division receives baseline data collection for 9 months then experiences interventions for the remainder of the trial.&#xD;
Interventions are behavioural and device:&#xD;
Behavioural: education about safety of delivery at a health facility, reminders to go for antenatal care, and a voucher for transport to the health facility at the time of delivery.&#xD;
Device: A birth kit with clean delivery supplies (soap, 2 pairs of gloves, cord clamps, surgical blade, and 600 mcg misoprostol for the woman to take immediately after the delivery to prevent postpartum hemorrhage).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Division 3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The third division receives baseline data collection for 12 months then experiences interventions for the remainder of the trial.&#xD;
Interventions are behavioural and device:&#xD;
Behavioural: education about safety of delivery at a health facility, reminders to go for antenatal care, and a voucher for transport to the health facility at the time of delivery.&#xD;
Device: A birth kit with clean delivery supplies (soap, 2 pairs of gloves, cord clamps, surgical blade, and 600 mcg misoprostol for the woman to take immediately after the delivery to prevent postpartum hemorrhage).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Division 4</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The fourth division receives baseline data collection for 15 months then experiences interventions for the remainder of the trial.&#xD;
nterventions are behavioural and device: Behavioural: education about safety of delivery at a health facility, reminders to go for antenatal care, and a voucher for transport to the health facility at the time of delivery.&#xD;
Device: A birth kit with clean delivery supplies (soap, 2 pairs of gloves, cord clamps, surgical blade, and 600 mcg misoprostol for the woman to take immediately after the delivery to prevent postpartum hemorrhage).</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Village meeting and travel vouchers</intervention_name>
    <description>The interventions are:&#xD;
Village meetings by community health workers to educate women and their families about safe birthing.&#xD;
Vouchers for free transport by motorcycle taxi drivers to access health facility at delivery.</description>
    <arm_group_label>Division 1</arm_group_label>
    <arm_group_label>Division 2</arm_group_label>
    <arm_group_label>Division 3</arm_group_label>
    <arm_group_label>Division 4</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Birth kit with misoprostol</intervention_name>
    <description>Provision of birth kit with clean delivery supplies (soap, 2 pairs of gloves, 2 cord clamps, surgical blade, and 600 mcg misoprostol for the woman to take immediately after the delivery to prevent postpartum hemorrhage).</description>
    <arm_group_label>Division 1</arm_group_label>
    <arm_group_label>Division 2</arm_group_label>
    <arm_group_label>Division 3</arm_group_label>
    <arm_group_label>Division 4</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Women must be pregnant.&#xD;
&#xD;
          2. Women must live in Rorya District, but not in Shirati Town.&#xD;
&#xD;
          3. Women must deliver in Rorya District .&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Women who live outside or deliver outside of Rorya District.&#xD;
&#xD;
          2. Women who deliver preterm, before they have exposure to all the interventions.&#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>Bwire Chirangi, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Director of Shirati KMT Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Gail C Webber, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Bruyere Research Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Shirati District Hospital Research Office</name>
      <address>
        <city>Shirati, Rorya District</city>
        <state>Mara Region</state>
        <country>Tanzania</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Tanzania</country>
  </location_countries>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>December 11, 2016</study_first_submitted>
  <study_first_submitted_qc>January 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 19, 2017</study_first_posted>
  <last_update_submitted>August 8, 2019</last_update_submitted>
  <last_update_submitted_qc>August 8, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 9, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Bruyere Research Institute</investigator_affiliation>
    <investigator_full_name>Gail Webber</investigator_full_name>
    <investigator_title>Associate Scientist</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Maternal Death</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>No</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/NCT03024905
org study id: 108026
nct id: NCT03024905
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
The purpose of this trial is to establish if several interventions will help women in rural
      Tanzania access health care services during pregnancy and at the time of delivery. The
      interventions include education about the importance of attending antenatal care visits with
      nurses and facility deliveries, a voucher for transport to access the health facility at the
      time of delivery, and supplies to be used either at the health facility, or on route if the
      women does not make it to the health facility.
In order to reduce the number of women dying in childbirth and to improve women's health in
      pregnancy, this trial is designed to assess if several interventions combined can increase
      the number of women delivering in health care facilities. The design of the study is
      "Multiple Baseline Design". Community health workers are trained to collect baseline data on
      women using mobile phones in one rural district in Tanzania. The district has four distinct
      divisions. After 6 months of baseline data in the district, one division will experience the
      interventions. The interventions are education about the importance of attending antenatal
      care visits with nurses and facility deliveries, a voucher for transport to access the health
      facility at the time of delivery, and birthing supplies to be used either at the health
      facility, or on route if the women does not make it to the health facility. The intervention
      will be begun in each of the other divisions in 3 month intervals (i.e. the second division
      starts to experience the interventions 3 months after the first, the third, 3 months after
      the second and the fourth 3 months after the third). The trial will continue for a total of
      27 months including the baseline period.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Facility births
time frame: During baseline vs during intervention periods until end of study (2 years)
description: Number of women attending health facilities for delivery
measure: Antenatal Care visits
time frame: During baseline vs during intervention until end of study (2 years)
description: Number of times women attend health facility for antenatal visits
measure: Postpartum visits
time frame: During baseline vs during intervention until end of study (2 years)
description: Number of women attending health facility for postpartum visits
measure: Use of transport intervention
time frame: During Intervention until end of study (2 years)
description: Number of women using the free transport intervention
measure: Use of birth kit
time frame: During Intervention until end of study (2 years)
description: Number of women using the birth kit
arm group label: Division 1
arm group type: Experimental
description: The first division receives baseline data collection for 6 months then experiences interventions for the remainder of the trial.
Interventions are behavioural and device:
Behavioural: education about safety of delivery at a health facility, reminders to go for antenatal care, and a voucher for transport to the health facility at the time of delivery.
Device: A birth kit with clean delivery supplies (soap, 2 pairs of gloves, cord clamps, surgical blade, and 600 mcg misoprostol for the woman to take immediately after the delivery to prevent postpartum hemorrhage).
arm group label: Division 2
arm group type: Experimental
description: The second division receives baseline data collection for 9 months then experiences interventions for the remainder of the trial.
Interventions are behavioural and device:
Behavioural: education about safety of delivery at a health facility, reminders to go for antenatal care, and a voucher for transport to the health facility at the time of delivery.
Device: A birth kit with clean delivery supplies (soap, 2 pairs of gloves, cord clamps, surgical blade, and 600 mcg misoprostol for the woman to take immediately after the delivery to prevent postpartum hemorrhage).
arm group label: Division 3
arm group type: Experimental
description: The third division receives baseline data collection for 12 months then experiences interventions for the remainder of the trial.
Interventions are behavioural and device:
Behavioural: education about safety of delivery at a health facility, reminders to go for antenatal care, and a voucher for transport to the health facility at the time of delivery.
Device: A birth kit with clean delivery supplies (soap, 2 pairs of gloves, cord clamps, surgical blade, and 600 mcg misoprostol for the woman to take immediately after the delivery to prevent postpartum hemorrhage).
arm group label: Division 4
arm group type: Experimental
description: The fourth division receives baseline data collection for 15 months then experiences interventions for the remainder of the trial.
nterventions are behavioural and device: Behavioural: education about safety of delivery at a health facility, reminders to go for antenatal care, and a voucher for transport to the health facility at the time of delivery.
Device: A birth kit with clean delivery supplies (soap, 2 pairs of gloves, cord clamps, surgical blade, and 600 mcg misoprostol for the woman to take immediately after the delivery to prevent postpartum hemorrhage).
intervention type: Behavioral
intervention name: Village meeting and travel vouchers
description: The interventions are:
Village meetings by community health workers to educate women and their families about safe birthing.
Vouchers for free transport by motorcycle taxi drivers to access health facility at delivery.
arm group label: Division 1
arm group label: Division 2
arm group label: Division 3
arm group label: Division 4
intervention type: Device
intervention name: Birth kit with misoprostol
description: Provision of birth kit with clean delivery supplies (soap, 2 pairs of gloves, 2 cord clamps, surgical blade, and 600 mcg misoprostol for the woman to take immediately after the delivery to prevent postpartum hemorrhage).
arm group label: Division 1
arm group label: Division 2
arm group label: Division 3
arm group label: Division 4
criteria: 
gender: Female
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Bwire Chirangi, MPH
role: Principal Investigator
affiliation: Director of Shirati KMT Hospital
last name: Gail C Webber, MD, PhD
role: Principal Investigator
affiliation: Bruyere Research Institute
facility: 
country: Tanzania
responsible party type: Principal Investigator
investigator affiliation: Bruyere Research Institute
investigator full name: Gail Webber
investigator title: Associate Scientist
mesh term: Maternal Death
mesh term: Misoprostol
sharing ipd: No