Birth Companion Intervention in Ethiopia, Kenya and Nigeria

December 5, 2024 updated by: Della Berhanu, Jhpiego

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10360

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

15 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
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.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Birth Companion Coverage
Time Frame: Between baseline and Endline survey (12 months after intervention is initiated).
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Choice of Birth Companion
Time Frame: Between baseline and Endline survey (12 months after intervention is initiated).
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).
Change in Experience of Care (Mothers'-Quantitative)
Time Frame: Between baseline and Endline survey (12 months after intervention is initiated).
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).
Experience of Care (Mothers'-Qualitative)
Time Frame: Quarterly after initiation of the intervention (for a period of 12 months).
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).
Feasibility (Unit managers and Providers-Quantitative)
Time Frame: Endline survey (12 months after intervention is initiated).
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).
Feasibility (Unit Managers-Qualitative)
Time Frame: Quarterly after the initiation of the intervention (for a period of 12 months).
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).
Acceptability (Mothers)
Time Frame: Quarterly after the initiation of the intervention (for a period of 12 months).
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).
Acceptability (Birth Companions)
Time Frame: Quarterly after the initiation of the intervention (for a period of 12 months).
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).
Acceptability (Providers)
Time Frame: Quarterly after the initiation of the intervention (for a period of 12 months).
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).
Acceptability (Unit Managers)
Time Frame: Quarterly after the initiation of the intervention (for a period of 12 months).
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).

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Potential association between baseline facility readiness and intervention coverage
Time Frame: Endline survey (12 months after intervention is initiated)
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)
Cost
Time Frame: Endline survey (12 months after intervention is initiated)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Jhpiego

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Bill and Melinda Gates Foundation
Addis Continental Institute of Public Health
St Paul's Hospital Millennium Medical College
International Center for Reproductive Health Kenya
Maternal and Reproductive Health Research Collective

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 10, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 18, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 18, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 28, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 3, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 4, 2022

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 10, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 5, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB00021183

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Per current Bill & Melinda Gates Foundation policy for study data

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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