Birth Companion Intervention in Ethiopia, Kenya and Nigeria

NCT05565196 | Completed

• 1 other identifier: IRB00021183
• Study Type: interventional
• Target: 10,360
• Locations: 3 countries
• Sites: 5

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.

Conditions

Maternal Care Patterns

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Choice of Birth Companion

  Between baseline and Endline survey (12 months after intervention is initiated).

• Change in Experience of Care (Mothers'-Quantitative)

  Between baseline and Endline survey (12 months after intervention is initiated).

• Experience of Care (Mothers'-Qualitative)

  Quarterly after initiation of the intervention (for a period of 12 months).

• Feasibility (Unit managers and Providers-Quantitative)

  Endline survey (12 months after intervention is initiated).

• Feasibility (Unit Managers-Qualitative)

  Quarterly after the initiation of the intervention (for a period of 12 months).

Other Outcomes (2)

• Potential association between baseline facility readiness and intervention coverage

  Endline survey (12 months after intervention is initiated)

• Cost

  Endline survey (12 months after intervention is initiated)

Study Arms (2)

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.

Behavioral: Birth companions

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.

Interventions

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.

Birth companion intervention arm

Eligibility Criteria

• Age: 15 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jhpiego: lead
• Addis Continental Institute of Public Health: collaborator
• St Paul's Hospital Millennium Medical College: collaborator
• International Center for Reproductive Health Kenya: collaborator
• Bill and Melinda Gates Foundation: collaborator
• Maternal and Reproductive Health Research Collective: collaborator

Study Sites (5)

Saint Paul's Millennium College

Addis Ababa, Ethiopia

Location

Machakos County Health Office

Machakos, Kenya

Location

Murang'a County Health Office

Murang’a, Kenya

Location

Kano State Health Office

Kano, Nigeria

Location

Nasarawa Sate Health Office

Karu, Nigeria

Location

Related Publications (1)

• 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.

  PMID: 37838662 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 6801
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research lead

Study Record Dates

• First Submitted: September 28, 2022
• First Posted: October 4, 2022
• Study Start: October 10, 2022
• Primary Completion: November 18, 2024
• Study Completion: November 18, 2024
• Last Updated: December 10, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

KE (2); NG (2); ET (1)