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| Name | Class |
|---|---|
| Addis Continental Institute of Public Health | OTHER |
| St Paul's Hospital Millennium Medical College | UNKNOWN |
| International Center for Reproductive Health Kenya | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Birth companion intervention arm | Experimental | 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. |
|
| Standard of care arm | No Intervention | Women who deliver in facilities in the experimental arm will be exposed to the standard of care for labor, delivery, and the postpartum period. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Birth companions | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Between baseline and Endline survey (12 months after intervention is initiated). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Between baseline and Endline survey (12 months after intervention is initiated). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
Facilities
Providers
Mothers
Birth companions
Unit managers
Exclusion Criteria:
Facilities
Providers
Mothers
Birth companions
Unit managers
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Saint Paul's Millennium College | Addis Ababa | Ethiopia | ||||
| Machakos County Health Office |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37838662 | Derived | Berhanu D, Bekele G, Melesse H, Taddese F, Owira P, Manguro G, Laleye O, Farouk Z, Balogun M, Hyre A, Mwaura S, Kiptoo OK, Wabwile VM, Mohammed S, Wolde K, Teno D, Eke EC, Don-Aki JO, Noguchi L, Suhowatsky S, Doggett E, Yenokyan G, Worku A. A clustered randomized control trial to assess feasibility, acceptability, and impact of implementing the birth companion intervention package in Ethiopia, Kenya, and Nigeria: study protocol. BMC Health Serv Res. 2023 Oct 14;23(1):1100. doi: 10.1186/s12913-023-10082-w. |
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Per current Bill & Melinda Gates Foundation policy for study data
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| Bill and Melinda Gates Foundation |
| OTHER |
| Maternal and Reproductive Health Research Collective | UNKNOWN |
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6801
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| 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. |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | Quarterly after the initiation of the intervention (for a period of 12 months). |
| 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. | Endline survey (12 months after intervention is initiated) |
| Machakos |
| Kenya |
| Murang'a County Health Office | Murang’a | Kenya |
| Kano State Health Office | Kano | Nigeria |
| Nasarawa Sate Health Office | Karu | Nigeria |