Maternal Care PatternsNCT05565196
Birth Companion Intervention in Ethiopia, Kenya and Nigeria
A study testing Birth companions in people with Maternal Care Patterns, run by Jhpiego at 5 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Maternal Care Patterns
- What is being tested?
- Birth companions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10,360 participants
- Where
- 5 sitesin 3 countries
- Study dates
- 10 Oct 2022to 18 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Show all 20Show fewer
- 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
Who cannot join
- 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.
Show all 11Show fewer
- 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
Trial locations and contacts
5 sites in 3 countries.
5 sites in 3 countries
Kenya2 sites
Machakos County Health Office
Machakos
Murang'a County Health Office
Murang’a
About this study
Official title: 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.
Read the 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
- Being tested
- Birth companions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Birth companionsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Between baseline and Endline survey (12 months after intervention is initiated).
Secondary outcomes (9)
Choice of Birth Companion
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.
Measured: Between baseline and Endline survey (12 months after intervention is initiated).
Change in Experience of Care (Mothers'-Quantitative)
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.
Measured: Between baseline and Endline survey (12 months after intervention is initiated).
Experience of Care (Mothers'-Qualitative)
In intervention facilities, among women who had birth companions investigators will use in-depth interviews to explore their perception of having a birth companion.
Measured: Quarterly after initiation of the intervention (for a period of 12 months).
Feasibility (Unit managers and Providers-Quantitative)
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.
Measured: Endline survey (12 months after intervention is initiated).
Feasibility (Unit Managers-Qualitative)
In intervention facilities, investigators will use key informant interviews to understand unit managers' perception on the feasibility of having birth companions.
Measured: Quarterly after the initiation of the intervention (for a period of 12 months).
Acceptability (Mothers)
In intervention facilities, investigators will use in-depth interviews to understand mothers' perception on the acceptability of having birth companions.
Measured: Quarterly after the initiation of the intervention (for a period of 12 months).
Acceptability (Birth Companions)
In intervention facilities, investigators will use in-depth interviews to understand birth companions' perception on the acceptability of being a birth companion.
Measured: Quarterly after the initiation of the intervention (for a period of 12 months).
Acceptability (Providers)
In intervention facilities, investigators will use focus group discussions to understand providers' perception on the acceptability of having birth companions.
Measured: Quarterly after the initiation of the intervention (for a period of 12 months).
Acceptability (Unit Managers)
In intervention facilities, investigators will use qualitative methods understand unit managers' perception on the acceptability of having birth companions.
Measured: Quarterly after the initiation of the intervention (for a period of 12 months).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2022
- Study start10 Oct 2022
- Primary completion18 Nov 2024
- Study completion18 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Maternal Care PatternsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10,360 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jhpiego
- Sponsor type
- University, hospital or other
- Collaborators
- Addis Continental Institute of Public Health, St Paul's Hospital Millennium Medical College, International Center for Reproductive Health Kenya, Bill and Melinda Gates Foundation, Maternal and Reproductive Health Research Collective
- Responsible party
- Principal investigator, Della Berhanu, Jhpiego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05565196
- Sponsor's protocol ID
- IRB00021183
- Status last verified
- Apr 2024
- First submitted
- 28 Sep 2022
- Last updated
- 10 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Per current Bill \& Melinda Gates Foundation policy for study data
Publications
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.
PubMed 37838662
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementing the Birth Companion Intervention Package in Ethiopia, Kenya and Nigeria: Feasibility, Acceptability, and Impact on Coverage of Facility Births Attended by a Companion.
- ClinicalTrials.gov ID
- NCT05565196
- Acronym / sponsor ID
- IRB00021183
- Conditions
- Maternal Care Patterns
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10,360 participants (actual)
- Lead sponsor
- JhpiegoUniversity, hospital or other
- Collaborators
- Addis Continental Institute of Public Health, St Paul's Hospital Millennium Medical College, International Center for Reproductive Health Kenya, Bill and Melinda Gates Foundation, Maternal and Reproductive Health Research Collective
- Study start
- 10 Oct 2022 (actual)
- Primary completion
- 18 Nov 2024 (actual)
- Study completion
- 18 Nov 2024 (actual)
- First posted
- 4 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Birth companion intervention arm | Experimental | Behavioral: Birth companionsWomen 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. |
| 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. |
Who may qualify
- Ages
- 15 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (20 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Birth companionsThe 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. | Behavioural | Birth companion intervention arm |
Primary outcome
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.
9 secondary outcomes
Choice of Birth Companion
Time frame: 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).
Experience of Care (Mothers'-Qualitative)
Time frame: 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).
Feasibility (Unit Managers-Qualitative)
Time frame: 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).
Acceptability (Birth Companions)
Time frame: 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).
Acceptability (Unit Managers)
Time frame: Quarterly after the initiation of the intervention (for a period of 12 months).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2024.
- Derived from this study: PubMed 37838662Berhanu 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.
- Individual participant dataSharing planned: No. Per current Bill \& Melinda Gates Foundation policy for study data
Related trials for Maternal Care Patterns
Active, not recruiting
Melanated Group Midwifery Care (MGMC)
Pregnancy Complications, Maternal Care Patterns
Active, not recruiting
An Intervention to Enhance Well-Being in Trauma Exposed New Mothers
Post-traumatic Stress Disorder, Dissociation
Active, not recruiting
An Adjunctive Neurofeedback Training Program to Enhance Wellness Among Trauma-Exposed Postpartum Mothers
Well-Being, Psychological, Dissociation
Active, not recruiting
Pivotal, Prospective, Multi-centre, Single-arm Study to Evaluate the Safety and Effectiveness of Oli for Identification of Patients, During the Intrapartum Period, Who Are at Higher Risk of Developing Abnormal Postpartum Uterine Bleeding, Including Postpartum Haemorrhage
Post Partum Haemorrhage, Maternal Care Patterns
Active, not recruitingObservational study
Utilization of Maternal Healthcare Services and Infant Feeding Practices
Maternal Health, Prenatal Care
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Birth companions in people with Maternal Care Patterns, run by Jhpiego at 5 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Kenya, Nigeria, Ethiopia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Birth Companion Coverage (time frame: Between baseline and Endline survey (12 months after intervention is initiated).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05565196, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2024.