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Birth Companion Intervention in Ethiopia, Kenya and Nigeria

NCT05565196 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10360

Last updated 2024-12-10

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Addis Continental Institute of Public Health

    collaborator OTHER

  • St Paul's Hospital Millennium Medical College

    collaborator UNKNOWN

  • International Center for Reproductive Health Kenya

    collaborator UNKNOWN

  • Bill and Melinda Gates Foundation

    collaborator OTHER

  • Maternal and Reproductive Health Research Collective

    collaborator UNKNOWN

  • Jhpiego

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
15 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-10-10
Primary Completion
2024-11-18
Completion
2024-11-18

Countries

  • Ethiopia
  • Kenya
  • Nigeria

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05565196 on ClinicalTrials.gov