- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05385380
A Cluster Randomized Controlled Intervention to Improve Institutional Birth Rate in a Rural District of Ethiopia
Promoting Safe Motherhood in Ethiopia: A Cluster Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Southern Nations Nationalities Regional State
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Arba Minch, Southern Nations Nationalities Regional State, Ethiopia, 21
- MEKDES KONDALE Gurara
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Safe motherhood Promotion(Educational, Counselling & Training) and maternity waiting homes upgrading
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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.
Other Names:
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No Intervention: Comparison
The current standard service package
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
through study completion, an average of 9 months
|
health facility visits after childbirth (postnatal care use)
Time Frame: through study completion, an average of 9 months
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Having visited postnatal clinic after delivery
|
through study completion, an average of 9 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
knowledge of obstetric danger signs
Time Frame: through study completion, an average of 9 months
|
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
|
through study completion, an average of 9 months
|
birth preparedness practice
Time Frame: through study completion, an average of 9 months
|
Proportion of pregnant women that made prior arrangements for birth and complications
|
through study completion, an average of 9 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- AMU-IUC-PHD3
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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