NCT05054504

Feasibility and Acceptability of Butterfly iQ

Integration of Butterfly iQ Point of Care Ultrasound Into Antenatal Care in Blantyre, Malawi: A Feasibility and Acceptability Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,575 (actual)
• Sponsor: Jhpiego · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Pregnancy Related

Interventions

Type	Name	Description
DEVICE	Butterfly 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.

Timeline

• Start date: 2021-10-06
• Primary completion: 2024-03-15
• Completion: 2024-03-15
• First posted: 2021-09-23
• Last updated: 2024-04-09

Locations

1 site across 1 country: Malawi

Regulatory

• FDA-regulated device study