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Kenya: The Barriers and Facilitators of Scaling up the Ellavi UBT for Postpartum Hemorrhage

NCT04502173 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2022-04-22

No results posted yet for this study

Summary

The purpose of this implementation research study is to generate evidence that informs the successful uptake and adoption of the Ellavi Uterine Balloon Tamponade (UBT) within Kenyan postpartum hemorrhage (PPH) management programs. The investigators aim to improve the likelihood that the Ellavi UBT will be integrated into the Kenyan 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 University of Nairobi affiliated hospitals in Nairobi county, Kenya. This study will therefore be exploratory and use a non-experimental design. 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. The investigators will then 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.

Conditions

  • Postpartum Hemorrhage

Interventions

DEVICE

Ellavi UBT

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 gather feedback from the 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)).

Sponsors & Collaborators

  • Department for International Development, United Kingdom

    collaborator OTHER_GOV

  • University of Nairobi

    collaborator OTHER

  • PATH

    lead OTHER

Principal Investigators

  • Megan Parker, PhD · PATH

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-01
Primary Completion
2021-09-30
Completion
2021-12-30

Countries

  • Kenya

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 NCT04502173 on ClinicalTrials.gov