An interventional study of Birth companions in Maternal Care Patterns, sponsored by Jhpiego. Completed at 5 sites in 3 countries. Open to female participants aged 15 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-10.
Sponsored by Jhpiego · Not applicable, Interventional, and Health services research
The study aims to assess the acceptability; feasibility; implementation cost; and penetration of the birth companion intervention introduced at health facilities. It is a multi-country study (Ethiopia, Kenya and Nigeria) with a two parallel arm cluster randomized controlled trial design. The study duration will approximately be 16 months.
The overall purpose of this study is to investigate how a birth companion (BC) intervention can be implemented to increase the proportion of women who are accompanied by a BC during labor, childbirth, and postpartum in Ethiopia, Kenya and Nigeria. After baseline data collection, facilities will be randomized in a 3:1 ratio; for every three facilities that receive the BC intervention, one facility will serve as a control facility. After randomization, over the course of two months, intervention facilities will start preparing to introduce the BC intervention to facilitate presence of BC during labor and delivery, while the control facilities will continue to provide the local standard of routine care. The intervention will have the following components: 1) Orient facilities and providers to benefits of BC; 2) Develop/update formal standard operating procedures (SOP) for implementing BC and develop plans to implement SOP; 3) Assess data required for implementation and an audit and feedback cycle for tracking coverage; 4) Assess and carry out modest structural changes in facilities to facilitate BC; 5) Use human centered design to develop materials/resources and a means to distinguish/recognize the BC, taking into account common barriers and misconceptions; 6) Prepare providers to integrate BC into care team; 7) Orient antenatal care (ANC) clients to BC rationale and selection; 8) Prepare BCs to support women; 9) Iterate model and track intervention/policies. Investigators will use a mixed methods approach to address the implementation research questions with exit interviews, health facility register data extraction, in-depth interviews, focus group discussions, and key informant interviews. Investigators will collect quarterly quantitative and qualitative data over the course of one week each, for a total of five data collection periods including baseline.
Jhpiego is the lead sponsor of 32 studies on the registry; 1 is open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Facilities
Providers
Mothers
Birth companions
Unit managers
Exclusion Criteria:
Facilities
Providers
Mothers
Birth companions
Unit managers
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Women who deliver in facilities in the experimental arm will be exposed to a facility-based intervention designed to improve companionship in labor, childbirth, and postpartum periods.
Behavioral: Birth companions
Women who deliver in facilities in the experimental arm will be exposed to the standard of care for labor, delivery, and the postpartum period.
The intervention will have the following components: 1) Orient facilities and providers to benefits of BC; 2) Develop/update formal standard operating procedures (SOP) for implementing BC and develop plans to implement SOP; 3) Assess data required for implementation and an audit and feedback cycle for tracking coverage; 4) Assess and carry out modest structural changes in facilities to facilitate BC; 5) Use human centered design to develop materials/resources and a means to distinguish/recognize the BC, taking into account common barriers and misconceptions; 6) Prepare providers to integrate BC into care team; 7) Orient ANC clients to BC rationale and selection; 8) Prepare BCs to support women; 9) Iterate model and track intervention/policies.
Change in Birth Companion Coverage
Between baseline and endline surveys, the investigators will measure the change in the proportion of women who are accompanied by a birth companion during labor, childbirth, and postpartum.
Time frame: Between baseline and Endline survey (12 months after intervention is initiated).
Choice of Birth Companion
Between baseline and endline surveys, among women who report having a birth companion, the investigators will measure the change in the proportion who report that their birth companion was the one of their choice.
Time frame: Between baseline and Endline survey (12 months after intervention is initiated).
Change in Experience of Care (Mothers'-Quantitative)
Between baseline and endline surveys, the investigators will measure the change in mothers' score on Person-Centered Maternity Care scale. This scale has 33 items with a score ranging from 0-98. A low score signifies a better outcome.
Time frame: Between baseline and Endline survey (12 months after intervention is initiated).
Experience of Care (Mothers'-Qualitative)
In intervention facilities, among women who had birth companions investigators will use in-depth interviews to explore their perception of having a birth companion.
Time frame: Quarterly after initiation of the intervention (for a period of 12 months).
Feasibility (Unit managers and Providers-Quantitative)
In intervention facilities, investigators will measure the proportion of providers and unit managers who report the physical environment of care supports the presence of birth companions during labor, birth, and the postnatal period.
Time frame: Endline survey (12 months after intervention is initiated).
Feasibility (Unit Managers-Qualitative)
In intervention facilities, investigators will use key informant interviews to understand unit managers' perception on the feasibility of having birth companions.
Time frame: Quarterly after the initiation of the intervention (for a period of 12 months).
Acceptability (Mothers)
In intervention facilities, investigators will use in-depth interviews to understand mothers' perception on the acceptability of having birth companions.
Time frame: Quarterly after the initiation of the intervention (for a period of 12 months).
Acceptability (Birth Companions)
In intervention facilities, investigators will use in-depth interviews to understand birth companions' perception on the acceptability of being a birth companion.
Time frame: Quarterly after the initiation of the intervention (for a period of 12 months).
Acceptability (Providers)
In intervention facilities, investigators will use focus group discussions to understand providers' perception on the acceptability of having birth companions.
Time frame: Quarterly after the initiation of the intervention (for a period of 12 months).
Acceptability (Unit Managers)
In intervention facilities, investigators will use qualitative methods understand unit managers' perception on the acceptability of having birth companions.
Time frame: Quarterly after the initiation of the intervention (for a period of 12 months).
Potential association between baseline facility readiness and intervention coverage
In intervention facilities, investigators will measure score on facility readiness to change (at baseline) to explore potential association with coverage of the intervention at endline. The tool used for facility staff has scale with 19 items and the score ranges from 0 to 57. The tool used for facility leaders has a scale with 34 items and a score ranging from 0 to 100. Low score means better outcome.
Time frame: Endline survey (12 months after intervention is initiated)
Cost
In intervention facilities investigators will collect data on facility-level costs for updates to physical environment of care and other implementation costs.
Time frame: Endline survey (12 months after intervention is initiated)
Plan to share: No — Per current Bill \& Melinda Gates Foundation policy for study data
No publications or documents are linked to this record.
This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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