Feasibility and Acceptability of Butterfly iQ

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.

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.

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:

• 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:

• 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:

• 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

• 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