Pregnancy Related
Conditions
Keywords
Butterfly IQ, Malawi, Blantyre, Antenatal care, ANC/PNC Research Collective, Point of care ultrasound, Bill & Melinda Gates Foundation, Johns Hopkins Research Project, Johns Hopkins Bloomberg School of Public Health
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. 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.
Interventions
DEVICEButterfly iQ
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.
Sponsors
Bill and Melinda Gates Foundation
Johns Hopkins Bloomberg School of Public Health
Kamuzu University of Health Sciences
Ministry of Health, Malawi
Jhpiego
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Eligibility criteria by phase and participant type Phase 1 Inclusion Criteria 1. Member of HC or hospital staff providing obstetric care. 2. Able and willing to comply with all study requirements and complete all study procedures. 3. Able and willing to provide informed consent to be screened for and to take part in the study. 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: 1. Member of HC or hospital staff providing obstetric care. 2. Able and willing to comply with all study requirements and complete all study procedures. 3. 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: 1. Age 18 years or older at Screening, as verified per site Standard Operating Procedures (SOPs). 2. At enrollment, present for first ANC visit. 3. Able and willing to comply with all study requirements and complete all Phase 2 study procedures. 4. Able and willing to provide informed consent to be screened for and to take part in Phase 2 of the study. 5. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of the intervention by observation of environments of care | 7 months | Proportion of participating HC with facilitative environments of care |
| Feasibility of the intervention by participant report | 7 months | Proportion of enrolled midwives who report the intervention to be feasible |
| Feasibility of the intervention by quality standards met (ultrasound) | 7 months | Proportion of ultrasound examinations found to meet quality standards |
| Feasibility of the intervention by quality standards met (ANC) | 7 months | Proportion of ANC visits (that included Butterfly IQ) found to meet quality standards |
| Feasibility of the intervention by observation of functioning systems | 7 months | Proportion of Butterfly IQ systems functioning at end of study period |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acceptability, by participant report (providers) | 7 months | Proportion of providers who find the intervention acceptable |
| Acceptability, by participant report (ANC clients) | 7 months | Proportion of ANC clients who find the intervention acceptable |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number and types of suspected and confirmed higher-risk conditions identified by ultrasound and recorded in study records | 7 months | Numbers of the following * Ectopic pregnancy * Multiple gestation * Abnormal placentation * Intrauterine fetal demise * Abnormalities of amniotic fluid, e.g., oligohydramnios, polyhydramnios * Fetal anomaly * Other condition not specified above |
| Gestational age at first ANC contact | 7 months | Median gestational age at first ANC contact |
Countries
Malawi
Outcome results
None listed