Birth Companion Intervention in Ethiopia, Kenya and Nigeria

Last updated: December 5, 2024
Sponsor: Jhpiego
Overall Status: Completed

Phase

N/A

Condition

N/A

Treatment

Birth companions

Clinical Study ID

NCT05565196
IRB00021183
  • Ages > 15
  • Female
  • Accepts Healthy Volunteers

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Facilities

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

  • Be willing to develop, adopt, and implement the BC standard operating procedures andother 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 MachakosCounty, Kenya or Nasarawa and Kano states, Nigeria

Providers

  • At the time of enrollment, providers need to work in ANC or labor and deliveryward(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 anemancipated 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

Exclusion Criteria:

Facilities

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

Providers

  • N/A

Mothers

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

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

Birth companions

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

Unit managers

  • N/A

Study Design

Total Participants: 10360
Treatment Group(s): 1
Primary Treatment: Birth companions
Phase:
Study Start date:
October 10, 2022
Estimated Completion Date:
November 18, 2024

Study 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.

Connect with a study center

  • Saint Paul's Millennium College

    Addis Ababa,
    Ethiopia

    Site Not Available

  • Machakos County Health Office

    Machakos,
    Kenya

    Site Not Available

  • Murang'a County Health Office

    Murang'a,
    Kenya

    Site Not Available

  • Kano State Health Office

    Kano,
    Nigeria

    Site Not Available

  • Nasarawa Sate Health Office

    Karu,
    Nigeria

    Site Not Available

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