Integration of Butterfly iQ Point of Care Ultrasound Into Antenatal Care in Blantyre, Malawi: A Feasibility and Acceptability Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Jhpiego
- Enrollment
- 1,575
- Locations
- 1
- Primary Endpoint
- Feasibility of the intervention by participant report
Study Overview
Brief Summary
The purpose of this study is to investigate feasibility and acceptability of a novel intervention to integrate Butterfly IQ into antenatal care (ANC) service delivery in Malawi. The study will also explore potential impact of the intervention on selected service delivery outcomes and identification of abnormal pregnancies.
Detailed Description
The purpose of this study is to investigate the feasibility and acceptability of a novel intervention to integrate Butterfly IQ into ANC service delivery in Blantyre, Malawi. This study will further the understanding of antenatal ultrasound in Malawi by testing the following hypothesis:
When planned and implemented collaboratively with local stakeholders, limited introduction and integration of point-of-care ultrasound with Butterfly iQ into ANC service delivery at health center level will be feasible and acceptable for health providers and clients.
The study intervention will include a multi-phased approach to design, introduction, improvement, and evaluation of Butterfly IQ for routine obstetric ultrasound integrated into ANC service delivery in Malawi.
Phase 1: Training Phase 1 includes training on Butterfly IQ, integration in ANC workflow, and referral/counter-referral within network.
Phase 2: Iterative Service Delivery Phase 2 includes weekly evaluation and iterative re-design of services.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Eligibility criteria by phase and participant type
- •Phase 1 Inclusion Criteria
- •Member of HC or hospital staff providing obstetric care.
- •Able and willing to comply with all study requirements and complete all study procedures.
- •Able and willing to provide informed consent to be screened for and to take part in the study.
Exclusion Criteria
- •Has any condition that, in the opinion of the investigator/designee, would preclude informed consent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.
- •Phase 2 Inclusion Criteria
- •Study Participant - Health Center and Hospital Staff:
- •Member of HC or hospital staff providing obstetric care.
- •Able and willing to comply with all study requirements and complete all study procedures.
- •Able and willing to provide informed consent to be screened for and to take part in the study.
- •Study Participant - ANC Clients:
- •Participants must meet all criteria to be eligible for inclusion in the study:
- •Age 18 years or older at Screening, as verified per site Standard Operating Procedures (SOPs).
- •At enrollment, present for first ANC visit.
- •Able and willing to comply with all study requirements and complete all Phase 2 study procedures.
- •Able and willing to provide informed consent to be screened for and to take part in Phase 2 of the study.
- •Intention to stay within study catchment area for study Phase 2 duration and willingness to give adequate locator information, as defined in site SOPs.
- •Phase 2 Exclusion Criteria
- •Study Participant - Health Center and Hospital Staff:
- •1. Has any condition that, in the opinion of the investigator/designee, would preclude informed consent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.
- •Study participant - ANC Clients:
- •1. Has any condition that, in the opinion of the investigator/designee, would preclude informed consent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives
- •Phase 3 Inclusion Criteria
- •Participated in Phase 1 or 2 of the study or newly recruited stakeholder interested in development or implementation of obstetric ultrasound in Malawi.
- •Able and willing to comply with all study requirements and complete all Phase 3 study procedures.
- •Able and willing to provide informed consent to be screened for and to take part in Phase 3 of the study.
- •Phase 3 Exclusion Criteria
- •1. Has any condition that, in the opinion of the investigator/designee, would preclude informed consent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives
Outcomes
Primary Outcomes
Feasibility of the intervention by participant report
Time Frame: 7 months
Proportion of enrolled midwives who report the intervention to be feasible
Feasibility of the intervention by quality standards met (ultrasound)
Time Frame: 7 months
Proportion of ultrasound examinations found to meet quality standards
Feasibility of the intervention by observation of functioning systems
Time Frame: 7 months
Proportion of Butterfly IQ systems functioning at end of study period
Feasibility of the intervention by observation of environments of care
Time Frame: 7 months
Proportion of participating HC with facilitative environments of care
Feasibility of the intervention by quality standards met (ANC)
Time Frame: 7 months
Proportion of ANC visits (that included Butterfly IQ) found to meet quality standards
Secondary Outcomes
- Acceptability, by participant report (providers)(7 months)
- Acceptability, by participant report (ANC clients)(7 months)