Birth Companion Intervention in Ethiopia, Kenya and Nigeria

Maternal Care Patterns Clinical Trial

Official title:

Implementing the Birth Companion Intervention Package in Ethiopia, Kenya and Nigeria: Feasibility, Acceptability, and Impact on Coverage of Facility Births Attended by a Companion.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05565196
• Other study ID #: IRB00021183
• Status: Recruiting
• Phase: N/A
• Start date: October 10, 2022
• Est. completion date: January 15, 2025

Study information

• Verified date: April 2024
• Source: Jhpiego
• Contact: Della Berhanu, PhD
• Phone: +251026783038
• Email: della.berhanu[@]jhpiego.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 4200
• Est. completion date: January 15, 2025
• Est. primary completion date: December 15, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 15 Years and older

Eligibility

Inclusion Criteria:

Facilities

• Prior to randomization, head of facility grants permission for facility to participate in the study

• Be willing to develop, adopt, and implement the BC standard operating procedures and other components of the BC intervention package

• Have more than 16 births per month during the past three months

• Be in the Addis Ababa and surrounding area, Ethiopia, in Muranga and Machakos County, Kenya or Nasarawa and Kano states, Nigeria

Providers

• At the time of enrollment, providers need to work in ANC or labor and delivery ward(s) of the study facilities

• Able and willing to provide informed consent to participate in the study

Mothers

• Per participant report, age 15 years or older

• Have vaginal birth

• Able and willing to provide informed consent to participate in the study

Birth companions

• Per participant report, for emancipated minors, age 15 years or older. If not an emancipated minor, per participant report, 18 years or older

• Was present at labor and/or delivery

• Identified as a BC by the delivering mother

• Able and willing to provide informed consent to participate in the study

Unit managers

• Involved in the implementation and management of the BC intervention

• Able and willing to provide informed consent to participate in the study

Exclusion Criteria:

Facilities

• Facility staff strike or other disturbance to routine care noted prior to randomization that would pose significant challenge(s) to achieving the study objectives

Providers

• N/A

Mothers

• Unable to participate in an interview due to their physical or emotional condition caused by an adverse delivery outcome.

• Unable to provide valid information because of mental or other serious health condition

Birth companions

• Unable to provide valid information because of mental or other serious health condition

Unit managers

• N/A

Related Conditions & MeSH terms

• Maternal Care Patterns

Intervention

Behavioral:
• Birth companions
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.

Locations

Country	Name	City	State
Ethiopia	Saint Paul's Millennium College	Addis Ababa
Kenya	Machakos County Health Office	Machakos
Kenya	Murang'a County Health Office	Murang'a
Nigeria	Kano State Health Office	Kano
Nigeria	Nasarawa Sate Health Office	Karu

Sponsors (6)

Lead Sponsor	Collaborator
Jhpiego	Addis Continental Institute of Public Health, Bill and Melinda Gates Foundation, International Center for Reproductive Health Kenya, Maternal and Reproductive Health Research Collective, St Paul's Hospital Millennium Medical College

Countries where clinical trial is conducted

Ethiopia,  Kenya,  Nigeria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	Endline survey (12 months after intervention is initiated)
Other	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)
Primary	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).
Secondary	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).
Secondary	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).
Secondary	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).
Secondary	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).
Secondary	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).
Secondary	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).
Secondary	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).
Secondary	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).
Secondary	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).