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| Name | Class |
|---|---|
| Bill and Melinda Gates Foundation | OTHER |
| Johns Hopkins Bloomberg School of Public Health | OTHER |
| Kamuzu University of Health Sciences | OTHER |
| Ministry of Health, Malawi |
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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.
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.
Phase 3: Final Evaluation Phase 3 includes evaluation for potential integration into current policies and frameworks; determination to pursue pending additional factors; or determination of incompatibility, as well as selected support for transition/handover, if applicable.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Other | The primary intervention is a multi-phase, mixed methods, implementation research study that will investigate the feasibility and acceptability of the limited introduction of ultrasound via the Butterfly iQ device into routine ANC service delivery at health center level in Blantyre, Malawi. The study will occur in three phases: 1) Training, 2) Iterative Service Delivery, and 3) Final Evaluation. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Butterfly iQ | Device | The primary intervention under study is the Butterfly iQ point-of-care ultrasound device, embedded in a larger program of training, iterative ANC service delivery design, and a final program evaluation. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of the intervention by participant report | Proportion of enrolled midwives who report the intervention to be feasible | 7 months |
| Feasibility of the intervention by quality standards met (ultrasound) | Proportion of ultrasound examinations found to meet quality standards | 7 months |
| Feasibility of the intervention by quality standards met (ANC) | Proportion of ANC visits (that included Butterfly IQ) found to meet quality standards | 7 months |
| Feasibility of the intervention by observation of functioning systems | Proportion of Butterfly IQ systems functioning at end of study period | 7 months |
| Feasibility of the intervention by observation of environments of care | Proportion of participating HC with facilitative environments of care | 7 months |
| Measure | Description | Time Frame |
|---|---|---|
| Acceptability, by participant report (providers) | Proportion of providers who find the intervention acceptable | 7 months |
| Acceptability, by participant report (ANC clients) | Proportion of ANC clients who find the intervention acceptable |
| Measure | Description | Time Frame |
|---|---|---|
| Gestational age at first ANC contact | Median gestational age at first ANC contact | 7 months |
| Number and types of suspected and confirmed higher-risk conditions identified by ultrasound and recorded in study records |
Eligibility criteria by phase and participant type
Phase 1 Inclusion Criteria
Phase 1 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.
Phase 2 Inclusion Criteria
Study Participant - Health Center and Hospital Staff:
Study Participant - ANC Clients:
Participants must meet all criteria to be eligible for inclusion in the study:
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
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
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| Name | Affiliation | Role |
|---|---|---|
| Lisa M Noguchi, PhD, MSN | Jhpiego, Johns Hopkins University | Study Director |
| Linly Seyama | University of Malawi College of Medicine, JHP Blantyre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Research Project | Blantyre | Malawi |
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| OTHER_GOV |
The primary intervention under study is the Butterfly iQ ultrasound, embedded in a larger program of training, iterative service delivery design, and a final program evaluation.
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| 7 months |
Numbers of the following
| 7 months |