Postpartum HemorrhageNCT05340777
Ghana: The Barriers and Facilitators of Scaling up the Ellavi UBT for Postpartum Hemorrhage
An observational study of Postpartum Hemorrhage, run by PATH at 3 sites in Ghana.
Trial summary
The purpose of this implementation science study is to generate evidence that informs the successful uptake and adoption of the Ellavi UBT within Ghana's PPH management programs. Read more about this study
- Who is it for?
- Ages 22 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Postpartum Hemorrhage
- What is being tested?
- Training Obstetric staff on Ellavi UBT
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 3 sitesGhana
- Study dates
- 18 Nov 2020to 28 Feb 2022
- Phase
- Observational
- 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 22 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Obstetrical care providers who recently participated in a PPH/Ellavi UBT training and/or obstetrical care providers who recently managed a refractory PPH event. The study participant must work in 1 of 3 participating facilities. The number of interviewees per site will vary depending on the size of the facility and number of refractory PPH events. Participants will be selected based on their participation in training sessions, or their management of a PPH event and will include obstetrical staff currently practicing at Tema General Hospital, Kasoa Polyclinic, or Ridge Hospital. Participants may be re-sampled with each use of the UBT.
Who may be able to join
- Labor ward obstetric staff
- Employed at 1 of the 3 hospitals participating in this study.
Who cannot join
- Non-obstetric staff
- Obstetric staff not employed at the 3 study hospitals
Trial locations and contacts
3 sites in 1 country.
Ghana3 sites
Ridge Hospital
Accra
Tema General Hospital
Accra
Kasoa Polyclinic
Kasoa, Central Region
About this study
Official title: GHANA: An Implementation Study on the Barriers and Facilitators of Scaling up the Innovative, Low-cost Ellavi Uterine Balloon Tamponade for Postpartum Hemorrhage
The purpose of this implementation science study is to generate evidence that informs the successful uptake and adoption of the Ellavi UBT within Ghana's PPH management programs. The investigators aim to improve the likelihood that the Ellavi UBT will be integrated into the health care system by obtaining critical feedback from stakeholders and health care providers on the barriers and facilitators towards its successful adoption and roll out. The research will be done in three purposively selected facilities near Accra Ghana: Tema General Hospital, Ridge Hospital, and Kasoa Polyclinic.
This study uses a nonexperimental design to collect data on implementation (e.g. # staff trained, usability, user confidence, acceptability, feasibility). The study team will train all obstetric healthcare staff (i.e. obstetricians, midwives, medical officers, clinical officers) involved in PPH management at the 3 participating healthcare facilities on the Ellavi UBT. The investigators will gather feedback from the obstetric healthcare workers (post-training and post-PPH) to understand the barriers to and facilitators of use in order to evaluate acceptability and feasibility among facilities providing different levels of care (level 4, level 5 (county), level 6 (tertiary)). This process will help to generate training and facility level recommendations for improved uptake and integration into the local maternal care package. Case report forms and semi-quantitative surveys will be completed by obstetrical care providers to evaluate the primary outcomes of acceptability and feasibility by measuring: context of use, accuracy of use, perceptions of the device, user confidence, acceptability, usability, facilitators of use, barriers to use, use-patterns, and insights into training effectiveness. The secondary outcomes will include financial data to determine the cost of introducing the Ellavi UBT into the Kenyan PPH management protocols and the health system. The study will not involve the storage of biological samples. There is not a direct benefit of the study to the individual participants. All study participants will sign consent forms.
Read the detailed description
The purpose of this implementation research study is to generate evidence that informs the successful uptake and adoption of the Ellavi UBT within Ghanaian PPH management programs for both public and private sector programs. The investigators aim to generate evidence for Ghanaian stakeholders to use in their decision-making around the use of Ellavi UBT in PPH management programs.
Specific objectives:
To determine the adoption, penetration, sustainability and fidelity of implementing the Ellavi UBT device into PPH care in three health care facilities. The investigators will explore the number of health workers and facilities that receive the PPH and Ellavi UBT training, and percent of health workers and facilities that adopt the Ellavi UBT device over the 10-month period. The investigators will also assess factors that influence the adoption, penetration, sustainability, and fidelity through an operations research survey, and the Ellavi UBT questionnaire.
To determine the appropriateness, acceptability and feasibility of using the Ellavi UBT in participating health facilities at various levels of care near Accra, the investigators will explore user comprehension of the Ellavi UBT usage steps, accuracy of use, perceptions of the device, attitudes towards the device, user confidence, usability, facilitators of use, barriers to use, use-patterns, and insights into training effectiveness.
- Sensitize senior management at each of the three participating facilities, separately.
- Conduct two half-day trainings on PPH and Ellavi UBT use at each of the three participating health facilities separated by: 1) obstetricians, medical and clinical officers, and 2) midwives.
- Collect individual initial (post-training) data to assess comprehension of Ellavi UBT usage steps, perceptions of the device, attitudes towards the device, user confidence, usability, and insights into training effectiveness.
- Case Management Form (CMF): Obstetrical care provider will complete a CMF within 24hrs (<24hrs) of managing each PPH event. This will inform the study team of how decision-making algorithms were applied and accuracy of use.
- Ellavi UBT Questionnaire: PATH-Ghana study team member will collect individual post (post-usage) Ellavi UBT use data (<72hrs) from each study participant (obstetrical care worker) to assess comprehension of Ellavi UBT usage steps, perceptions of the device, attitudes towards the device, user confidence, usability, facilitators of use, barriers to use, use-patterns, and insights into training effectiveness.
- PATH-Ghana study staff will record secondary data from hospital registry books over a 9 month duration of this study (January-Sept 2021) in comparison to the same period in 2020 to examine changes in use of condom catheters, and Ellavi UBTs.
- Use the Consolidated Framework for Implementation Research (CFIR) to identify constructs with the potential to influence the introduction and use of Ellavi UBT. These constructs will be mapped to questions in the questionnaire, and will be analyzed to identify their influence on Ellavi UBT use. Constructs that have influence on the implementation of UBTs (both positively and negatively) will be disseminated for use in future introduction and scale up of Ellavi UBTs.
To disseminate the information in national, regional, and international forums to support information sharing, increased awareness of the role of UBT for refractory PPH, and adoption of its use.
- Summarize how the Ellavi UBT can be integrated into curriculums, guidelines, and hospital systems (e.g. patient-provider friendly materials) by analyzing the key facilitators and barriers.
- Host a national level meeting with Kenyan MOH stakeholders and participating facilities
- Publish and disseminate findings in a peer-reviewed journal h. Present at international conferences and forums, as funding permits. Show the use of Ellavi UBT using poster presentations and demonstration sessions at international obstetrics meetings: FIGO, WHO UBT group, Women Deliver as funding permits.
- Conditions
- Postpartum Hemorrhage
- Being tested
- Training Obstetric staff on Ellavi UBT
- Medical subject headings
- Postpartum Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Training Obstetric staff on Ellavi UBTDevice
The study team will train all obstetric healthcare staff (i.e. obstetricians, midwives, medical officers, clinical officers) involved in PPH management at the participating healthcare facilities on use of the Ellavi UBT. This will be done to ensure staff are trained on the newly registered and provided medical device. We will gather feedback on how to improve the training curriculum from participants. We will also gather information from the healthcare workers immediately post-use of an Ellavi UBT device following their management of a refractory PPH case. These surveys will help us to understand the barriers to and facilitators of use in order to evaluate acceptability and feasibility among facilities providing different levels of PPH care.
What is being measured
The primary outcome is the main question the study is designed to answer.
Semi-quantitative post-training survey on the appropriateness and acceptability of using the Ellavi UBT device
- Appropriateness will be measured by capturing # deliveries and # postpartum hemorrhage (PPH) cases typically managed per month by the obstetric staff surveyed.
- Acceptability will be measured by surveying obstetric staff on their perception of Ellavi UBT effectiveness in comparison to other PPH treatments, attitudes towards the device post training, device usability measures, and user-confidence operating the device.
Measured: 10 months
Facility survey (quantitative) to determine adoption, penetration, and sustainability
- Adoption will be measured by the # of facilities (of 3 total) who ever used the Ellavi UBT over the 10 month period.
- Penetration/Reach will be measured by determining the % of total staff (employed at the 3 hospitals) who were participated in our Ellavi UBT/PPH training courses.
- Sustainability is measured by the # facilities (of 3 total) who ever used the Ellavi UBT 4 months after the training (at least 1 time), and the # of facilities that used the Ellavi UBT every month for 6 months after the training.
Measured: 10 months
Semi-quantitative post-UBT-use survey on fidelity to training skills, and feasibility of using the Ellavi UBT device
- Feasibility will be measured by capturing the # of Ellavi UBT devices used to manage the PPH events, and barriers/enablers to use of the device.
- Fidelity will be measured by questions asked on accuracy of use (fidelity to the training)
Measured: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2022
- Study start18 Nov 2020
- Primary completion30 Sep 2021
- Study completion28 Feb 2022
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 Postpartum HemorrhageStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- PATH
- Sponsor type
- University, hospital or other
- Collaborators
- Ghana Health Services
- Responsible party
- Principal investigator, Megan Parker, PATH
- Investigators
- Megan Parker, PhD, Principal investigator, PATH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05340777
- Sponsor's protocol ID
- 1514537
- Status last verified
- Apr 2022
- First submitted
- 14 Sep 2021
- Last updated
- 22 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The de-identified data will be shared with the funder in the form of a study report. If data are held on a public database (due to publication requirements), they will not be linked to the study participant and their identity would not be revealed.
Publications
Parker ME, Qureshi Z, Deganus S, Soki J, Cofie P, Dapaah P, Owusu R, Gwako G, Osoti A, Ogutu O, Opira J, Sunkwa-Mills G, Boamah M, Srofenyoh E, Aboagye P, Fofie C, Kaliti S, Morozoff C, Secor A, Metzler M, Abu-Haydar E. Introduction of the Ellavi uterine balloon tamponade into the Kenyan and Ghanaian maternal healthcare package for improved postpartum haemorrhage management: an implementation research study. BMJ Open. 2023 Feb 3;13(2):e066907. doi: 10.1136/bmjopen-2022-066907.
PubMed 36737079
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GHANA: An Implementation Study on the Barriers and Facilitators of Scaling up the Innovative, Low-cost Ellavi Uterine Balloon Tamponade for Postpartum Hemorrhage
- ClinicalTrials.gov ID
- NCT05340777
- Acronym / sponsor ID
- 1514537
- Conditions
- Postpartum Hemorrhage
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- PATHUniversity, hospital or other
- Collaborators
- Ghana Health Services
- Study start
- 18 Nov 2020 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 28 Feb 2022 (actual)
- First posted
- 22 Apr 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 purpose of this implementation science study is to generate evidence that informs the successful uptake and adoption of the Ellavi UBT within Ghana's PPH management programs. The investigators aim to improve the likelihood that the Ellavi UBT will be integrated into the health care system by obtaining critical feedback from stakeholders and health care providers on the barriers and facilitators towards its successful adoption and roll out. The research will be done in three purposively selected facilities near Accra Ghana: Tema General Hospital, Ridge Hospital, and Kasoa Polyclinic.
This study uses a nonexperimental design to collect data on implementation (e.g. # staff trained, usability, user confidence, acceptability, feasibility). The study team will train all obstetric healthcare staff (i.e. obstetricians, midwives, medical officers, clinical officers) involved in PPH management at the 3 participating healthcare facilities on the Ellavi UBT. The investigators will gather feedback from the obstetric healthcare workers (post-training and post-PPH) to understand the barriers to and facilitators of use in order to evaluate acceptability and feasibility among facilities providing different levels of care (level 4, level 5 (county), level 6 (tertiary)). This process will help to generate training and facility level recommendations for improved uptake and integration into the local maternal care package. Case report forms and semi-quantitative surveys will be completed by obstetrical care providers to evaluate the primary outcomes of acceptability and feasibility by measuring: context of use, accuracy of use, perceptions of the device, user confidence, acceptability, usability, facilitators of use, barriers to use, use-patterns, and insights into training effectiveness. The secondary outcomes will include financial data to determine the cost of introducing the Ellavi UBT into the Kenyan PPH management protocols and the health system. The study will not involve the storage of biological samples. There is not a direct benefit of the study to the individual participants. All study participants will sign consent forms.
Detailed description
The purpose of this implementation research study is to generate evidence that informs the successful uptake and adoption of the Ellavi UBT within Ghanaian PPH management programs for both public and private sector programs. The investigators aim to generate evidence for Ghanaian stakeholders to use in their decision-making around the use of Ellavi UBT in PPH management programs.
Specific objectives:
To determine the adoption, penetration, sustainability and fidelity of implementing the Ellavi UBT device into PPH care in three health care facilities. The investigators will explore the number of health workers and facilities that receive the PPH and Ellavi UBT training, and percent of health workers and facilities that adopt the Ellavi UBT device over the 10-month period. The investigators will also assess factors that influence the adoption, penetration, sustainability, and fidelity through an operations research survey, and the Ellavi UBT questionnaire.
To determine the appropriateness, acceptability and feasibility of using the Ellavi UBT in participating health facilities at various levels of care near Accra, the investigators will explore user comprehension of the Ellavi UBT usage steps, accuracy of use, perceptions of the device, attitudes towards the device, user confidence, usability, facilitators of use, barriers to use, use-patterns, and insights into training effectiveness.
- Sensitize senior management at each of the three participating facilities, separately.
- Conduct two half-day trainings on PPH and Ellavi UBT use at each of the three participating health facilities separated by: 1) obstetricians, medical and clinical officers, and 2) midwives.
- Collect individual initial (post-training) data to assess comprehension of Ellavi UBT usage steps, perceptions of the device, attitudes towards the device, user confidence, usability, and insights into training effectiveness.
- Case Management Form (CMF): Obstetrical care provider will complete a CMF within 24hrs (<24hrs) of managing each PPH event. This will inform the study team of how decision-making algorithms were applied and accuracy of use.
- Ellavi UBT Questionnaire: PATH-Ghana study team member will collect individual post (post-usage) Ellavi UBT use data (<72hrs) from each study participant (obstetrical care worker) to assess comprehension of Ellavi UBT usage steps, perceptions of the device, attitudes towards the device, user confidence, usability, facilitators of use, barriers to use, use-patterns, and insights into training effectiveness.
- PATH-Ghana study staff will record secondary data from hospital registry books over a 9 month duration of this study (January-Sept 2021) in comparison to the same period in 2020 to examine changes in use of condom catheters, and Ellavi UBTs.
- Use the Consolidated Framework for Implementation Research (CFIR) to identify constructs with the potential to influence the introduction and use of Ellavi UBT. These constructs will be mapped to questions in the questionnaire, and will be analyzed to identify their influence on Ellavi UBT use. Constructs that have influence on the implementation of UBTs (both positively and negatively) will be disseminated for use in future introduction and scale up of Ellavi UBTs.
To disseminate the information in national, regional, and international forums to support information sharing, increased awareness of the role of UBT for refractory PPH, and adoption of its use.
- Summarize how the Ellavi UBT can be integrated into curriculums, guidelines, and hospital systems (e.g. patient-provider friendly materials) by analyzing the key facilitators and barriers.
- Host a national level meeting with Kenyan MOH stakeholders and participating facilities
- Publish and disseminate findings in a peer-reviewed journal h. Present at international conferences and forums, as funding permits. Show the use of Ellavi UBT using poster presentations and demonstration sessions at international obstetrics meetings: FIGO, WHO UBT group, Women Deliver as funding permits.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 22 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Obstetrical care providers who recently participated in a PPH/Ellavi UBT training and/or obstetrical care providers who recently managed a refractory PPH event. The study participant must work in 1 of 3 participating facilities. The number of interviewees per site will vary depending on the size of the facility and number of refractory PPH events. Participants will be selected based on their participation in training sessions, or their management of a PPH event and will include obstetrical staff currently practicing at Tema General Hospital, Kasoa Polyclinic, or Ridge Hospital. Participants may be re-sampled with each use of the UBT.
Key inclusion criteria (2 listed)
- Labor ward obstetric staff
- Employed at 1 of the 3 hospitals participating in this study.
Key exclusion criteria (2 listed)
- Non-obstetric staff
- Obstetric staff not employed at the 3 study hospitals
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 |
|---|---|---|
| Training Obstetric staff on Ellavi UBTThe study team will train all obstetric healthcare staff (i.e. obstetricians, midwives, medical officers, clinical officers) involved in PPH management at the participating healthcare facilities on use of the Ellavi UBT. This will be done to ensure staff are trained on the newly registered and provided medical device. We will gather feedback on how to improve the training curriculum from participants. We will also gather information from the healthcare workers immediately post-use of an Ellavi UBT device following their management of a refractory PPH case. These surveys will help us to understand the barriers to and facilitators of use in order to evaluate acceptability and feasibility among facilities providing different levels of PPH care. | Device | – |
Primary outcome
Semi-quantitative post-training survey on the appropriateness and acceptability of using the Ellavi UBT device
Time frame: 10 months
* Appropriateness will be measured by capturing # deliveries and # postpartum hemorrhage (PPH) cases typically managed per month by the obstetric staff surveyed. * Acceptability will be measured by surveying obstetric staff on their perception of Ellavi UBT effectiveness in comparison to other PPH treatments, attitudes towards the device post training, device usability measures, and user-confidence operating the device.
Facility survey (quantitative) to determine adoption, penetration, and sustainability
Time frame: 10 months
* Adoption will be measured by the # of facilities (of 3 total) who ever used the Ellavi UBT over the 10 month period. * Penetration/Reach will be measured by determining the % of total staff (employed at the 3 hospitals) who were participated in our Ellavi UBT/PPH training courses. * Sustainability is measured by the # facilities (of 3 total) who ever used the Ellavi UBT 4 months after the training (at least 1 time), and the # of facilities that used the Ellavi UBT every month for 6 months after the training.
Semi-quantitative post-UBT-use survey on fidelity to training skills, and feasibility of using the Ellavi UBT device
Time frame: 10 months
* Feasibility will be measured by capturing the # of Ellavi UBT devices used to manage the PPH events, and barriers/enablers to use of the device. * Fidelity will be measured by questions asked on accuracy of use (fidelity to the training)
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 22 Apr 2022.
- Derived from this study: PubMed 36737079Parker ME, Qureshi Z, Deganus S, Soki J, Cofie P, Dapaah P, Owusu R, Gwako G, Osoti A, Ogutu O, Opira J, Sunkwa-Mills G, Boamah M, Srofenyoh E, Aboagye P, Fofie C, Kaliti S, Morozoff C, Secor A, Metzler M, Abu-Haydar E. Introduction of the Ellavi uterine balloon tamponade into the Kenyan and Ghanaian maternal healthcare package for improved postpartum haemorrhage management: an implementation research study. BMJ Open. 2023 Feb 3;13(2):e066907. doi: 10.1136/bmjopen-2022-066907.
- Individual participant dataSharing planned: No. The de-identified data will be shared with the funder in the form of a study report. If data are held on a public database (due to publication requirements), they will not be linked to the study participant and their identity would not be revealed.
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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.
Megan Parker, PhD principal investigator
PATH
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postpartum Hemorrhage, run by PATH at 3 sites in Ghana.
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 2 inclusion and 2 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 22 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Ghana. 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?
Semi-quantitative post-training survey on the appropriateness and acceptability of using the Ellavi UBT device (time frame: 10 months). The study lists 3 primary outcomes in all. 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 NCT05340777, 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 22 Apr 2022.