Birth Companion Intervention in Ethiopia, Kenya and Nigeria

NCT ID: NCT05565196

Last Updated: 2024-12-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10360 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-10
• Study Completion Date: 2024-11-18

Brief 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.

Detailed 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.

Conditions

Maternal Care Patterns

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Birth companion intervention arm

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.

Group Type: EXPERIMENTAL

Birth companions

Intervention Type: 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.

Standard of care arm

Women who deliver in facilities in the experimental arm will be exposed to the standard of care for labor, delivery, and the postpartum period.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 15 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Addis Continental Institute of Public Health

OTHER

Sponsor Role: collaborator

St Paul's Hospital Millennium Medical College

UNKNOWN

Sponsor Role: collaborator

International Center for Reproductive Health Kenya

UNKNOWN

Sponsor Role: collaborator

Bill and Melinda Gates Foundation

OTHER

Sponsor Role: collaborator

Maternal and Reproductive Health Research Collective

UNKNOWN

Sponsor Role: collaborator

Jhpiego

OTHER

Sponsor Role: lead

Responsible Party

Della Berhanu

Research lead

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Saint Paul's Millennium College

Addis Ababa, , Ethiopia

Machakos County Health Office

Machakos, , Kenya

Murang'a County Health Office

Murang’a, , Kenya

Kano State Health Office

Kano, , Nigeria

Nasarawa Sate Health Office

Karu, , Nigeria

Countries

Ethiopia; Kenya; Nigeria

References

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.

Reference Type: DERIVED

PMID: 37838662 (View on PubMed)

Other Identifiers

IRB00021183

Identifier Type: -

Identifier Source: org_study_id