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An Implementation Study of Interventions to Promote Safe Motherhood in Jimma Zone Ethiopia

Primary Purpose

Maternal Mortality, Maternal Morbidity

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
MWA intervention
IEC intervention
Sponsored by
University of Ottawa
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Maternal Mortality focused on measuring Maternity Waiting Area, Ethiopia, Community Leader, Religious Leader, Skilled birth attendance, Postnatal care, Information, Education, Communication, Safe Motherhood, Health Extension Worker, Antenatal Care

Eligibility Criteria

15 Years - undefined (Child, Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Women who were pregnant up to one year prior to the baseline survey and had a live birth, stillbirth or abortion (spontaneous or induced) and are residents in the study districts during the survey period are eligible to take part in the study.

Exclusion Criteria:

  • Women who are not able to provide informed consent due to severe illness or mental health conditions.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    No Intervention

    Arm Label

    MWA+IEC intervention

    IEC intervention

    Control

    Arm Description

    Outcomes

    Primary Outcome Measures

    Facility-based birth coverage
    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).

    Secondary Outcome Measures

    Antenatal care coverage
    Proportion of women who report making at least one antenatal care visit to a health facility during their last pregnancy.
    Postnatal care coverage
    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.

    Full Information

    First Posted
    September 27, 2017
    Last Updated
    November 3, 2020
    Sponsor
    University of Ottawa
    Collaborators
    Jimma University, Ethiopian Ministry of Health, Jimma Zone
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03299491
    Brief Title
    An Implementation Study of Interventions to Promote Safe Motherhood in Jimma Zone Ethiopia
    Official Title
    An Implementation Study of Interventions to Promote Safe Motherhood in Jimma Zone Ethiopia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    October 15, 2016 (Actual)
    Primary Completion Date
    May 1, 2019 (Actual)
    Study Completion Date
    October 2020 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Ottawa
    Collaborators
    Jimma University, Ethiopian Ministry of Health, Jimma Zone

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Maternal Mortality, Maternal Morbidity
    Keywords
    Maternity Waiting Area, Ethiopia, Community Leader, Religious Leader, Skilled birth attendance, Postnatal care, Information, Education, Communication, Safe Motherhood, Health Extension Worker, Antenatal Care

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    3784 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    MWA+IEC intervention
    Arm Type
    Experimental
    Arm Title
    IEC intervention
    Arm Type
    Experimental
    Arm Title
    Control
    Arm Type
    No Intervention
    Intervention Type
    Other
    Intervention Name(s)
    MWA intervention
    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.
    Intervention Type
    Other
    Intervention Name(s)
    IEC intervention
    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.
    Primary Outcome Measure Information:
    Title
    Facility-based birth coverage
    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).
    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)
    Secondary Outcome Measure Information:
    Title
    Antenatal care coverage
    Description
    Proportion of women who report making at least one antenatal care visit to a health facility during their last pregnancy.
    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)
    Title
    Postnatal care coverage
    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.
    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)

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    15 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Women who were pregnant up to one year prior to the baseline survey and had a live birth, stillbirth or abortion (spontaneous or induced) and are residents in the study districts during the survey period are eligible to take part in the study. Exclusion Criteria: Women who are not able to provide informed consent due to severe illness or mental health conditions.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Manisha Kulkarni, PhD
    Organizational Affiliation
    University of Ottawa
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Lakew Abebe, MPH
    Organizational Affiliation
    Jimma University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    33092565
    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.
    Results Reference
    result
    PubMed Identifier
    31801584
    Citation
    Kurji J, Kulkarni MA, Gebretsadik LA, Wordofa MA, Morankar S, Bedru KH, Bulcha G, Thavorn K, Labonte R, Taljaard M. Effectiveness of upgraded maternity waiting homes and local leader training in improving institutional births among women in the Jimma zone, Ethiopia: study protocol for a cluster-randomized controlled trial. Trials. 2019 Dec 4;20(1):671. doi: 10.1186/s13063-019-3755-z.
    Results Reference
    derived

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    An Implementation Study of Interventions to Promote Safe Motherhood in Jimma Zone Ethiopia

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