Maternal Health ServicesNCT05385380
A Cluster Randomized Controlled Intervention to Improve Institutional Birth Rate in a Rural District of Ethiopia
A study testing Safe motherhood Promotion in people with Maternal Health Services, run by Prof Yves Jacquemyn at 1 site in Ethiopia.
Trial summary
Despite the efforts from the government, maternal healthcare services utilization is far below the recommended level in Ethiopia with a high urban-rural disparity. Currently, two-thirds of pregnant women do not receive the recommended number of antenatal care, more than 50% of births are not attended by skilled birth… Read more about this study
- Who is it for?
- Ages 15 to 49 years, women only
- Conditions the study is for
- Maternal Health Services
- What is being tested?
- Safe motherhood Promotion
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 727 participants
- Where
- 1 siteEthiopia
- Study dates
- 14 Sep 2019to 20 Nov 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 to 49 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Those who had resided for at least six months in the selected kebele clusters and had given birth in the five years preceding the survey were included to maintain homogeneity of information exposure. Another criterion for inclusion was a maximum gestational age of 27 weeks (end of second trimester) as participants were required to attend at least two sessions of the proposed promotional intervention before their due date.
Who cannot join
- Those who met the inclusion criteria but were critically ill at the time of enrolment and/or those who were reluctant to participate were excluded.
Trial locations and contacts
1 site in 1 country.
Ethiopia1 site
MEKDES KONDALE Gurara
Arba Minch, Southern Nations Nationalities Regional State, 21
About this study
Official title: Promoting Safe Motherhood in Ethiopia: A Cluster Randomized Controlled Trial
Despite the efforts from the government, maternal healthcare services utilization is far below the recommended level in Ethiopia with a high urban-rural disparity. Currently, two-thirds of pregnant women do not receive the recommended number of antenatal care, more than 50% of births are not attended by skilled birth attendants, and two-thirds of postpartum women do not receive postnatal checks, according to the 2019 EDHS report. There is also evidence that the rate of continuity of maternity care completion is low, implying that pregnant women are not getting the most out of the existing healthcare services. In Ethiopia, the rural communities are scattered over a wide geographic area some with difficult mountains and valleys. Hence, geographic barriers and limited information sources are likely to influence women's access to skilled birth attendance. As part of improving access and overcoming physical or geographical inaccessibility in rural areas, maternity waiting homes; residential lodgings built near healthcare facilities where expectant women near or at term would stay till the onset of labor is one of the measures taken by the Ethiopian government. The majority of the rural populations commonly have a lower perception of health services in general, and many traditional practices support behaviors that are inconsistent with effective health interventions. Thus, there is a challenge concerning behavior (social norms, beliefs, and culture) from the demand side related to utilizing maternity services on top of non/partial functionality of existing waiting homes. Therefore, this research project aimed at promoting access to and utilization of maternal healthcare services utilization in southern Ethiopia.
Read the detailed description
Health centers and kebeles (villages) in the study setting were randomly assigned to intervention or comparison. We recruited all eligible pregnant women who reside in the respective selected health centres' catchment areas. In the intervention areas, community health workers (unpaid and volunteer women) were identified in consultation with the head of the villages/local leaders/. They received training on safe motherhood, the benefit and importance of maternity homes, identification of local beliefs, traditions and taboos that are barriers to birth preparation, stay in maternity homes and the use of maternal health services. The main functions of these trained community health worker in the intervention clusters include facilitating training sessions for pregnant women, assisting pregnant women in the preparation of birth preparedness plan, supporting pregnant women in starting and sustaining maternity care (prenatal care, skilled delivery and postnatal care). Pregnant women were also trained in the intervention clusters (12 sessions/4 sessions per cluster).
The training of both community health workers and pregnant women was based on a video story titled "Why Did Mr. X Die, Retold?" and a manual on working with individuals, families and communities to improve maternal and neonatal health from the World Health Organization.
After getting permission from the World Health Organization to use the video, we translated it into the local language and used it as an introduction during training. The training was designed based on the findings of preliminary studies and was intended to educate pregnant women about danger signs during pregnancy, labour and the postpartum period, about the birth preparation plan, the benefits and importance of waiting homes. In addition, it also covered how to develop a birth plan that included waiting home with the help of community health workers, as well as correcting misconceptions (belief-related barriers). The intervention was based on principles from the theory of planned behavior and the health belief model. These models were considered to offer direction for what types of variables and processes may be important in shaping maternal health behaviors and thus needed to be addressed in the intervention. The theory of planned behavior is used to explain and predict behavior based on attitudes, norms, and intentions and stipulates that an individual intention to act (behavior) is essentially a function of that individual's attitude toward that behavior and perceptions of social subjective norms. The health belief model which describes how health beliefs interact with modifying factors (e.g., perceived seriousness of problem) to determine health behaviors was also considered in developing the intervention.
The comparison group continued to receive maternal health information and services that are provided as part of the routine healthcare system. Both the baseline and end-line data were managed by trained interviewers using a mobile application supporting Open Data Kit. Data were analyzed through descriptive and inferential statistics (Chi-square test, McNemar tests and multi-level mixed-effects logistic regression analysis). For all analyses, a p-value of <0.05 was considered the level of significance.
- Conditions
- Maternal Health Services
- Being tested
- Safe motherhood Promotion
- Keywords
- Antenatal care, Births attended by skilled health providers, Birth Preparedness Plan, Postnatal care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Safe motherhood PromotionBehavioural
Also called improving maternity waiting homes
Interventions included the training of community members, who subsequently led participatory educational sessions on safe motherhood topics with pregnant females. The project staff identified 2 community health workers and 15 female volunteers from each kebele cluster and trained them as research implementers. The implementers received 2 days of training led by the project team. The project staff and research implementers conducted safe-motherhood training comprising 2 h of information presentations and discussions with pregnant females in the intervention clusters. In addition to the pregnant-female intervention strategy, we also conducted a four-day training programme on clinical skills for local maternal and child healthcare providers in the study area. MWH intervention was also implemented in the intervention group, including upgrades to existing MWH services per national guidelines to standardize services and create a homelike environment for pregnant females.
| Study group | Role | What they receive |
|---|---|---|
| Safe motherhood Promotion(Educational, Counselling & Training) and maternity waiting homes upgrading | Experimental | 1. Improving the quality of maternal health services in health centers (training for midwives in basic emergency obstetric care and upgrading maternity waiting homes to the level to provide basic accommodation to address access-related barriers
2. Training community health workers with the aim of improving their knowledge about safe motherhood and about how to prepare a birth plan, including stays in maternity waiting homes
3. Training pregnant women Receives: Behavioral: Safe motherhood Promotion |
| Comparison | No intervention | The current standard service package |
What is being measured
The primary outcome is the main question the study is designed to answer.
the location of the delivery (home vs. health facility)
institutional birth was used to indicate skilled birth attendance as trained health workers do not conduct deliveries outside of health facilities in these areas.
Measured: through study completion, an average of 9 months
health facility visits after childbirth (postnatal care use)
Having visited postnatal clinic after delivery
Measured: through study completion, an average of 9 months
Secondary outcomes (2)
knowledge of obstetric danger signs
Knowledge of birth danger signs was measured using the pregnant females' unprompted responses to the question related to the key danger signs during pregnancy, childbirth and postnatal period
Measured: through study completion, an average of 9 months
birth preparedness practice
Proportion of pregnant women that made prior arrangements for birth and complications
Measured: through study completion, an average of 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2022
- Study start14 Sep 2019
- Primary completion17 Oct 2020
- Study completion20 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Maternal Health ServicesStudies 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
- Model description
- A total of 727 pregnant women were recruited and followed up to six months after delivery in this quasi-experimental, two-arm, controlled study. In the intervention group, eligible pregnant women received training to promote safe motherhood, supported by the story "Why Did Mr. X Die, Retold?" and a booklet on working with individuals, families and communities to promote maternal and neonatal health. Pregnant women received counselling (12 sessions/4 sessions per cluster) and biweekly check-ins were performed by community health workers. Pregnant women are encouraged to stay in maternity waiting homes, which have been upgraded to accommodate pregnant women while they wait for their baby to arrive. The control group received standard maternal health information and services as part of the standard health care system.
- Masking
- None (open label)
- Enrolment
- 727 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prof Yves Jacquemyn
- Sponsor type
- University, hospital or other
- Collaborators
- Flemish Interuniversity Council (VLIR), Arba Minch University
- Responsible party
- Sponsor-investigator, Prof Yves Jacquemyn, Universiteit Antwerpen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05385380
- Sponsor's protocol ID
- AMU-IUC-PHD3
- Status last verified
- May 2022
- First submitted
- 10 May 2022
- Last updated
- 1 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gurara MK, Draulans V, Jacquemyn Y, Van Geertruyden JP. Evaluation of a community-based intervention package to improve knowledge of obstetric danger signs, birth preparedness, and institutional delivery care utilization in Arba Minch Zuria District, Ethiopia: a cluster-randomized trial. Reprod Health. 2023 Nov 18;20(1):169. doi: 10.1186/s12978-023-01713-w.
PubMed 37980484
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Safe Motherhood in Ethiopia: A Cluster Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05385380
- Acronym / sponsor ID
- AMU-IUC-PHD3
- Conditions
- Maternal Health Services
- Keywords
- Antenatal care, Births attended by skilled health providers, Birth Preparedness Plan, Postnatal care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 727 participants (actual)
- Lead sponsor
- Prof Yves JacquemynUniversity, hospital or other
- Collaborators
- Flemish Interuniversity Council (VLIR), Arba Minch University
- Study start
- 14 Sep 2019 (actual)
- Primary completion
- 17 Oct 2020 (actual)
- Study completion
- 20 Nov 2020 (actual)
- First posted
- 23 May 2022 (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.
Despite the efforts from the government, maternal healthcare services utilization is far below the recommended level in Ethiopia with a high urban-rural disparity. Currently, two-thirds of pregnant women do not receive the recommended number of antenatal care, more than 50% of births are not attended by skilled birth attendants, and two-thirds of postpartum women do not receive postnatal checks, according to the 2019 EDHS report. There is also evidence that the rate of continuity of maternity care completion is low, implying that pregnant women are not getting the most out of the existing healthcare services. In Ethiopia, the rural communities are scattered over a wide geographic area some with difficult mountains and valleys. Hence, geographic barriers and limited information sources are likely to influence women's access to skilled birth attendance. As part of improving access and overcoming physical or geographical inaccessibility in rural areas, maternity waiting homes; residential lodgings built near healthcare facilities where expectant women near or at term would stay till the onset of labor is one of the measures taken by the Ethiopian government. The majority of the rural populations commonly have a lower perception of health services in general, and many traditional practices support behaviors that are inconsistent with effective health interventions. Thus, there is a challenge concerning behavior (social norms, beliefs, and culture) from the demand side related to utilizing maternity services on top of non/partial functionality of existing waiting homes. Therefore, this research project aimed at promoting access to and utilization of maternal healthcare services utilization in southern Ethiopia.
Detailed description
Health centers and kebeles (villages) in the study setting were randomly assigned to intervention or comparison. We recruited all eligible pregnant women who reside in the respective selected health centres' catchment areas. In the intervention areas, community health workers (unpaid and volunteer women) were identified in consultation with the head of the villages/local leaders/. They received training on safe motherhood, the benefit and importance of maternity homes, identification of local beliefs, traditions and taboos that are barriers to birth preparation, stay in maternity homes and the use of maternal health services. The main functions of these trained community health worker in the intervention clusters include facilitating training sessions for pregnant women, assisting pregnant women in the preparation of birth preparedness plan, supporting pregnant women in starting and sustaining maternity care (prenatal care, skilled delivery and postnatal care). Pregnant women were also trained in the intervention clusters (12 sessions/4 sessions per cluster).
The training of both community health workers and pregnant women was based on a video story titled "Why Did Mr. X Die, Retold?" and a manual on working with individuals, families and communities to improve maternal and neonatal health from the World Health Organization.
After getting permission from the World Health Organization to use the video, we translated it into the local language and used it as an introduction during training. The training was designed based on the findings of preliminary studies and was intended to educate pregnant women about danger signs during pregnancy, labour and the postpartum period, about the birth preparation plan, the benefits and importance of waiting homes. In addition, it also covered how to develop a birth plan that included waiting home with the help of community health workers, as well as correcting misconceptions (belief-related barriers). The intervention was based on principles from the theory of planned behavior and the health belief model. These models were considered to offer direction for what types of variables and processes may be important in shaping maternal health behaviors and thus needed to be addressed in the intervention. The theory of planned behavior is used to explain and predict behavior based on attitudes, norms, and intentions and stipulates that an individual intention to act (behavior) is essentially a function of that individual's attitude toward that behavior and perceptions of social subjective norms. The health belief model which describes how health beliefs interact with modifying factors (e.g., perceived seriousness of problem) to determine health behaviors was also considered in developing the intervention.
The comparison group continued to receive maternal health information and services that are provided as part of the routine healthcare system. Both the baseline and end-line data were managed by trained interviewers using a mobile application supporting Open Data Kit. Data were analyzed through descriptive and inferential statistics (Chi-square test, McNemar tests and multi-level mixed-effects logistic regression analysis). For all analyses, a p-value of <0.05 was considered the level of significance.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A total of 727 pregnant women were recruited and followed up to six months after delivery in this quasi-experimental, two-arm, controlled study. In the intervention group, eligible pregnant women received training to promote safe motherhood, supported by the story "Why Did Mr. X Die, Retold?" and a booklet on working with individuals, families and communities to promote maternal and neonatal health. Pregnant women received counselling (12 sessions/4 sessions per cluster) and biweekly check-ins were performed by community health workers. Pregnant women are encouraged to stay in maternity waiting homes, which have been upgraded to accommodate pregnant women while they wait for their baby to arrive. The control group received standard maternal health information and services as part of the standard health care system.
| Arm | Type | Receives |
|---|---|---|
| Safe motherhood Promotion(Educational, Counselling & Training) and maternity waiting homes upgrading | Experimental | Behavioral: Safe motherhood Promotion1. Improving the quality of maternal health services in health centers (training for midwives in basic emergency obstetric care and upgrading maternity waiting homes to the level to provide basic accommodation to address access-related barriers 2. Training community health workers with the aim of improving their knowledge about safe motherhood and about how to prepare a birth plan, including stays in maternity waiting homes 3. Training pregnant women |
| Comparison | No intervention | –The current standard service package |
Who may qualify
- Ages
- 15 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Those who had resided for at least six months in the selected kebele clusters and had given birth in the five years preceding the survey were included to maintain homogeneity of information exposure. Another criterion for inclusion was a maximum gestational age of 27 weeks (end of second trimester) as participants were required to attend at least two sessions of the proposed promotional intervention before their due date.
Key exclusion criteria (1 listed)
- Those who met the inclusion criteria but were critically ill at the time of enrolment and/or those who were reluctant to participate were excluded.
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 |
|---|---|---|
| Safe motherhood PromotionAlso: improving maternity waiting homesInterventions included the training of community members, who subsequently led participatory educational sessions on safe motherhood topics with pregnant females. The project staff identified 2 community health workers and 15 female volunteers from each kebele cluster and trained them as research implementers. The implementers received 2 days of training led by the project team. The project staff and research implementers conducted safe-motherhood training comprising 2 h of information presentations and discussions with pregnant females in the intervention clusters. In addition to the pregnant-female intervention strategy, we also conducted a four-day training programme on clinical skills for local maternal and child healthcare providers in the study area. MWH intervention was also implemented in the intervention group, including upgrades to existing MWH services per national guidelines to standardize services and create a homelike environment for pregnant females. | Behavioural | Safe motherhood Promotion(Educational, Counselling & Training) and maternity waiting homes upgrading |
Primary outcome
the location of the delivery (home vs. health facility)
Time frame: through study completion, an average of 9 months
institutional birth was used to indicate skilled birth attendance as trained health workers do not conduct deliveries outside of health facilities in these areas.
health facility visits after childbirth (postnatal care use)
Time frame: through study completion, an average of 9 months
Having visited postnatal clinic after delivery
2 secondary outcomes
knowledge of obstetric danger signs
Time frame: through study completion, an average of 9 months
birth preparedness practice
Time frame: through study completion, an average of 9 months
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 1 Jun 2022.
- Derived from this study: PubMed 37980484Gurara MK, Draulans V, Jacquemyn Y, Van Geertruyden JP. Evaluation of a community-based intervention package to improve knowledge of obstetric danger signs, birth preparedness, and institutional delivery care utilization in Arba Minch Zuria District, Ethiopia: a cluster-randomized trial. Reprod Health. 2023 Nov 18;20(1):169. doi: 10.1186/s12978-023-01713-w.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Safe motherhood Promotion in people with Maternal Health Services, run by Prof Yves Jacquemyn at 1 site in Ethiopia.
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 1 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ethiopia. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
the location of the delivery (home vs. health facility) (time frame: through study completion, an average of 9 months). The study lists 2 primary outcomes in all. 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 NCT05385380, which also lists 1 linked publication.
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 1 Jun 2022.