<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/NCT03299491</url>
  </required_header>
  <id_info>
    <org_study_id>108028-002</org_study_id>
    <nct_id>NCT03299491</nct_id>
  </id_info>
  <brief_title>An Implementation Study of Interventions to Promote Safe Motherhood in Jimma Zone Ethiopia</brief_title>
  <official_title>An Implementation Study of Interventions to Promote Safe Motherhood in Jimma Zone Ethiopia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Ottawa</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Jimma University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Ethiopian Ministry of Health, Jimma Zone</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Ottawa</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Ethiopia has one of the highest rates of maternal mortality among all countries in Africa and&#xD;
      indeed worldwide, with a maternal mortality ratio of 676 per 100,000 live births in 2011&#xD;
      (UNFPA, 2012). The majority of maternal deaths are preventable through early detection and&#xD;
      management of complications, and access to adequate obstetric care (Say et al, 2014).&#xD;
      However, in 2011 only 34% of women received antenatal care, 10% of births were delivered at a&#xD;
      health facility and 7% of women received postnatal care during the first two days after&#xD;
      delivery (Ethiopian DHS, 2011). Large distances and poor access to transport are two major&#xD;
      obstacles that women face when trying to access services. In order to facilitate timely&#xD;
      access to obstetric care, the Ethiopian Government introduced Maternity Waiting Areas (MWAs)&#xD;
      at health centres to enable women to stay close to health facilities as they await delivery.&#xD;
      Utilization of MWAs has generally been low due to the poor state of the homes and lack of&#xD;
      adequate community support. This study aims to evaluate the effectiveness of two&#xD;
      interventions to promote safe motherhood in increasing coverage of maternal health care&#xD;
      services: (i) upgraded MWAs (ii) community and religious leader sensitization using&#xD;
      information, education and communication (IEC) materials. The IEC materials are expected to&#xD;
      increase leader awareness and support of antenatal care, facility deliveries, postnatal care&#xD;
      and MWA use. Together with increased use of functional MWAs, improved support from leaders is&#xD;
      expected to increase the proportion of facility-based births in interventions area. The&#xD;
      interventions are also expected to positively impact antenatal care and postnatal care use in&#xD;
      the study districts.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A three-arm cluster trial design will be used to measure the impact of the intervention&#xD;
      packages in three districts (Gomma, Seka Chekorsa, Kersa) in Jimma Zone, Ethiopia.&#xD;
      Twenty-four clusters with 160 individuals each are required to detect a 17% change in the&#xD;
      primary outcome (proportion of facility-based births) with 80% power,assuming a cluster&#xD;
      autocorrelation of 0.8 and an intra-cluster correlation coefficient of 0.1. Primary health&#xD;
      care units (PHCU) which consist of a health centre and several community-based health posts&#xD;
      will serve as trial clusters. All PHCUs with maternity waiting areas (MWAs) constructed will&#xD;
      be eligible for selection. Eligible women will be randomly selected from PHCU catchment areas&#xD;
      stratified by MWA functionality and health centre basic emergency obstetric care (BEmOC)&#xD;
      capacity. This is to ensure balanced distribution of poorly functioning MWAs and facilities&#xD;
      with diminished BEmOC capacity between trial arms.&#xD;
&#xD;
      Cross-sectional household surveys will be conducted with eligible women to collect&#xD;
      information on socio-demographics, knowledge, attitudes and practices regarding maternal&#xD;
      health services, reproductive history and maternal health service utilization. Surveys will&#xD;
      be administered by trained interviewers on tablet computers programmed using Open Data Kit at&#xD;
      baseline prior to intervention roll out and at endline. Multilevel regression models will be&#xD;
      used to quantify the effect of the intervention packages on outcomes of interest. Random&#xD;
      effect terms for PHCUs will be included to account for the clustered nature of the data.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 15, 2016</start_date>
  <completion_date type="Actual">October 2020</completion_date>
  <primary_completion_date type="Actual">May 1, 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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Facility-based birth coverage</measure>
    <time_frame>Information on the primary outcome will be collected through surveys at baseline (prior to intervention roll out) and endline (approximately one and a half years after intervention roll out has commenced)</time_frame>
    <description>Proportion of women who report giving birth to their last child at a health facility (health centre or hospital) which has skilled birth attendants present (doctor, midwife, clinical nurse).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Antenatal care coverage</measure>
    <time_frame>Information on secondary outcomes will be collected through surveys at baseline (prior to intervention roll out) and endline (approximately one and a half years after intervention roll out has commenced)</time_frame>
    <description>Proportion of women who report making at least one antenatal care visit to a health facility during their last pregnancy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postnatal care coverage</measure>
    <time_frame>Information on secondary outcomes will be collected through surveys at baseline (prior to intervention roll out) and endline (approximately one and a half years after intervention roll out has commenced)</time_frame>
    <description>Proportion of women who report receiving a checkup from a healthcare worker at least once during the 42 days after delivery of their last child.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">3784</enrollment>
  <condition>Maternal Mortality</condition>
  <condition>Maternal Morbidity</condition>
  <arm_group>
    <arm_group_label>MWA+IEC intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>IEC intervention</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>Other</intervention_type>
    <intervention_name>MWA intervention</intervention_name>
    <description>The MWA intervention will involve upgrading existing maternity waiting areas to ensure that essential supplies and services are available to create a comfortable environment for women to temporarily reside in and have easy access to skilled obstetric services.</description>
    <arm_group_label>MWA+IEC intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>IEC intervention</intervention_name>
    <description>Community and religious leaders will each attend one-day workshops designed using participatory, adult learning methods to help participants better understand the importance of maternal health care services, identify barriers to accessing care and to strategize how to promote utilization of services. Half-day workshops will conducted in subsequent years to build on shared experiences.&#xD;
Health extension workers will attend 3-day workshops to identify enablers and barriers to implementation of the safe motherhood components of the health extension program and strategize on how to engage community and religious leaders to support access to maternal health care services in their communities.&#xD;
Half-day workshops will conducted in subsequent years for each of the participant groups to build on shared experiences.</description>
    <arm_group_label>IEC intervention</arm_group_label>
    <arm_group_label>MWA+IEC intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women who were pregnant up to one year prior to the baseline survey and had a live&#xD;
             birth, stillbirth or abortion (spontaneous or induced) and are residents in the study&#xD;
             districts during the survey period are eligible to take part in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Women who are not able to provide informed consent due to severe illness or mental&#xD;
             health conditions.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Manisha Kulkarni, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Ottawa</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Lakew Abebe, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Jimma University</affiliation>
  </overall_official>
  <results_reference>
    <citation>Kurji J, Gebretsadik LA, Wordofa MA, Morankar S, Bedru KH, Bulcha G, Bergen N, Kiros G, Asefa Y, Asfaw S, Mamo A, Endale E, Thavorn K, Labonte R, Taljaard M, Kulkarni MA. Effectiveness of upgraded maternity waiting homes and local leader training on improving institutional births: a cluster-randomized controlled trial in Jimma, Ethiopia. BMC Public Health. 2020 Oct 22;20(1):1593. doi: 10.1186/s12889-020-09692-4.</citation>
    <PMID>33092565</PMID>
  </results_reference>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>September 27, 2017</study_first_submitted>
  <study_first_submitted_qc>September 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 3, 2017</study_first_posted>
  <last_update_submitted>November 3, 2020</last_update_submitted>
  <last_update_submitted_qc>November 3, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 5, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Ottawa</investigator_affiliation>
    <investigator_full_name>Manisha Kulkarni, PhD</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Maternity Waiting Area</keyword>
  <keyword>Ethiopia</keyword>
  <keyword>Community Leader</keyword>
  <keyword>Religious Leader</keyword>
  <keyword>Skilled birth attendance</keyword>
  <keyword>Postnatal care</keyword>
  <keyword>Information, Education, Communication</keyword>
  <keyword>Safe Motherhood</keyword>
  <keyword>Health Extension Worker</keyword>
  <keyword>Antenatal Care</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Maternal 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/NCT03299491
org study id: 108028-002
nct id: NCT03299491
lead sponsor: 
collaborator: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
Ethiopia has one of the highest rates of maternal mortality among all countries in Africa and
      indeed worldwide, with a maternal mortality ratio of 676 per 100,000 live births in 2011
      (UNFPA, 2012). The majority of maternal deaths are preventable through early detection and
      management of complications, and access to adequate obstetric care (Say et al, 2014).
      However, in 2011 only 34% of women received antenatal care, 10% of births were delivered at a
      health facility and 7% of women received postnatal care during the first two days after
      delivery (Ethiopian DHS, 2011). Large distances and poor access to transport are two major
      obstacles that women face when trying to access services. In order to facilitate timely
      access to obstetric care, the Ethiopian Government introduced Maternity Waiting Areas (MWAs)
      at health centres to enable women to stay close to health facilities as they await delivery.
      Utilization of MWAs has generally been low due to the poor state of the homes and lack of
      adequate community support. This study aims to evaluate the effectiveness of two
      interventions to promote safe motherhood in increasing coverage of maternal health care
      services: (i) upgraded MWAs (ii) community and religious leader sensitization using
      information, education and communication (IEC) materials. The IEC materials are expected to
      increase leader awareness and support of antenatal care, facility deliveries, postnatal care
      and MWA use. Together with increased use of functional MWAs, improved support from leaders is
      expected to increase the proportion of facility-based births in interventions area. The
      interventions are also expected to positively impact antenatal care and postnatal care use in
      the study districts.
A three-arm cluster trial design will be used to measure the impact of the intervention
      packages in three districts (Gomma, Seka Chekorsa, Kersa) in Jimma Zone, Ethiopia.
      Twenty-four clusters with 160 individuals each are required to detect a 17% change in the
      primary outcome (proportion of facility-based births) with 80% power,assuming a cluster
      autocorrelation of 0.8 and an intra-cluster correlation coefficient of 0.1. Primary health
      care units (PHCU) which consist of a health centre and several community-based health posts
      will serve as trial clusters. All PHCUs with maternity waiting areas (MWAs) constructed will
      be eligible for selection. Eligible women will be randomly selected from PHCU catchment areas
      stratified by MWA functionality and health centre basic emergency obstetric care (BEmOC)
      capacity. This is to ensure balanced distribution of poorly functioning MWAs and facilities
      with diminished BEmOC capacity between trial arms.

      Cross-sectional household surveys will be conducted with eligible women to collect
      information on socio-demographics, knowledge, attitudes and practices regarding maternal
      health services, reproductive history and maternal health service utilization. Surveys will
      be administered by trained interviewers on tablet computers programmed using Open Data Kit at
      baseline prior to intervention roll out and at endline. Multilevel regression models will be
      used to quantify the effect of the intervention packages on outcomes of interest. Random
      effect terms for PHCUs will be included to account for the clustered nature of the data.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: Single (Outcomes Assessor)
measure: Facility-based birth coverage
time frame: Information on the primary outcome will be collected through surveys at baseline (prior to intervention roll out) and endline (approximately one and a half years after intervention roll out has commenced)
description: Proportion of women who report giving birth to their last child at a health facility (health centre or hospital) which has skilled birth attendants present (doctor, midwife, clinical nurse).
measure: Antenatal care coverage
time frame: Information on secondary outcomes will be collected through surveys at baseline (prior to intervention roll out) and endline (approximately one and a half years after intervention roll out has commenced)
description: Proportion of women who report making at least one antenatal care visit to a health facility during their last pregnancy.
measure: Postnatal care coverage
time frame: Information on secondary outcomes will be collected through surveys at baseline (prior to intervention roll out) and endline (approximately one and a half years after intervention roll out has commenced)
description: Proportion of women who report receiving a checkup from a healthcare worker at least once during the 42 days after delivery of their last child.
arm group label: MWA+IEC intervention
arm group type: Experimental
arm group label: IEC intervention
arm group type: Experimental
arm group label: Control
arm group type: No Intervention
intervention type: Other
intervention name: MWA intervention
description: The MWA intervention will involve upgrading existing maternity waiting areas to ensure that essential supplies and services are available to create a comfortable environment for women to temporarily reside in and have easy access to skilled obstetric services.
arm group label: MWA+IEC intervention
intervention type: Other
intervention name: IEC intervention
description: Community and religious leaders will each attend one-day workshops designed using participatory, adult learning methods to help participants better understand the importance of maternal health care services, identify barriers to accessing care and to strategize how to promote utilization of services. Half-day workshops will conducted in subsequent years to build on shared experiences.
Health extension workers will attend 3-day workshops to identify enablers and barriers to implementation of the safe motherhood components of the health extension program and strategize on how to engage community and religious leaders to support access to maternal health care services in their communities.
Half-day workshops will conducted in subsequent years for each of the participant groups to build on shared experiences.
arm group label: IEC intervention
arm group label: MWA+IEC intervention
criteria: 
gender: Female
minimum age: 15 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Manisha Kulkarni, PhD
role: Principal Investigator
affiliation: University of Ottawa
last name: Lakew Abebe, MPH
role: Principal Investigator
affiliation: Jimma University
citation: Kurji J, Gebretsadik LA, Wordofa MA, Morankar S, Bedru KH, Bulcha G, Bergen N, Kiros G, Asefa Y, Asfaw S, Mamo A, Endale E, Thavorn K, Labonte R, Taljaard M, Kulkarni MA. Effectiveness of upgraded maternity waiting homes and local leader training on improving institutional births: a cluster-randomized controlled trial in Jimma, Ethiopia. BMC Public Health. 2020 Oct 22;20(1):1593. doi: 10.1186/s12889-020-09692-4.
PMID: 33092565
responsible party type: Principal Investigator
investigator affiliation: University of Ottawa
investigator full name: Manisha Kulkarni, PhD
investigator title: Assistant Professor
mesh term: Maternal Death