Maternal MortalityNCT03299491
An Implementation Study of Interventions to Promote Safe Motherhood in Jimma Zone Ethiopia
A study testing MWA intervention and IEC intervention in people with Maternal Mortality and Maternal Morbidity, run by University of Ottawa.
Trial 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). Read more about this study
- Who is it for?
- Ages 15 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Maternal Mortality, Maternal Morbidity
- What is being tested?
- MWA intervention and IEC intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,784 participants
- Where
- No sites listed yet
- Study dates
- 15 Oct 2016to Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Women who are not able to provide informed consent due to severe illness or mental health conditions.
About this study
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.
Read the 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.
- Conditions
- Maternal Mortality, Maternal Morbidity
- Being tested
- MWA intervention, IEC intervention
- Keywords
- Maternity Waiting Area, Ethiopia, Community Leader, Religious Leader, Skilled birth attendance, Postnatal care, Information, Education, Communication, Safe Motherhood, Health Extension Worker, Antenatal Care
- Medical subject headings
- Maternal Death, Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MWA interventionOther
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.
IEC interventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| MWA+IEC intervention | Experimental | Not described Receives: Other: MWA intervention; Other: IEC intervention |
| IEC intervention | Experimental | Not described Receives: Other: IEC intervention |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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 outcomes (2)
Antenatal care coverage
Proportion of women who report making at least one antenatal care visit to a health facility during their last pregnancy.
Measured: 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)
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.
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2017
- Study start15 Oct 2016
- Primary completion1 May 2019
- Study completionOct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Maternal MortalityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 3,784 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Ottawa
- Sponsor type
- University, hospital or other
- Collaborators
- Jimma University, Ethiopian Ministry of Health, Jimma Zone
- Responsible party
- Principal investigator, Manisha Kulkarni, PhD, University of Ottawa
- Investigators
- Manisha Kulkarni, PhD, Principal investigator, University of OttawaLakew Abebe, MPH, Principal investigator, Jimma University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03299491
- Sponsor's protocol ID
- 108028-002
- Status last verified
- Nov 2020
- First submitted
- 27 Sep 2017
- Last updated
- 5 Nov 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 33092565Kurji 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.
PubMed 31801584
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Implementation Study of Interventions to Promote Safe Motherhood in Jimma Zone Ethiopia
- ClinicalTrials.gov ID
- NCT03299491
- Acronym / sponsor ID
- 108028-002
- Conditions
- Maternal Mortality, Maternal Morbidity
- Keywords
- Maternity Waiting Area, Ethiopia, Community Leader, Religious Leader, Skilled birth attendance, Postnatal care, Information, Education, Communication, Safe Motherhood
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,784 participants (actual)
- Lead sponsor
- University of OttawaUniversity, hospital or other
- Collaborators
- Jimma University, Ethiopian Ministry of Health, Jimma Zone
- Study start
- 15 Oct 2016 (actual)
- Primary completion
- 1 May 2019 (actual)
- Study completion
- Oct 2020 (actual)
- First posted
- 3 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MWA+IEC intervention | Experimental | Other: MWA intervention, Other: IEC intervention |
| IEC intervention | Experimental | Other: IEC intervention |
| Control | No intervention | – |
Who may qualify
- Ages
- 15 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Women who are not able to provide informed consent due to severe illness or mental health conditions.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MWA interventionThe 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. | Other | MWA+IEC intervention |
| IEC interventionCommunity 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. | Other | IEC intervention, MWA+IEC intervention |
Primary outcome
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)
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).
2 secondary outcomes
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2020.
- Results publication: PubMed 33092565Kurji 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.
- Derived from this study: PubMed 31801584Kurji 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Manisha Kulkarni, PhD principal investigator
University of Ottawa
Lakew Abebe, MPH principal investigator
Jimma University
Questions about this trial
What is this clinical trial studying?
A study testing MWA intervention and IEC intervention in people with Maternal Mortality and Maternal Morbidity, run by University of Ottawa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03299491, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2020.