Feasibility and Acceptability of Butterfly iQ

Not Applicable

Completed

• Conditions: Pregnancy Related
• Interventions: Device: Butterfly iQ

• Registration Number: NCT05054504
• Lead Sponsor: Jhpiego

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.

Study Timeline

• Study First Submitted: 2021-09-04
• Study First Submitted QC: 2021-09-14
• Study First Posted: 2021-09-23
• Study Start: 2021-10-06
• Primary Completion: 2024-03-15
• Study Completion: 2024-03-15
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-05
• Last Update Posted: 2024-04-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1575

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention	Butterfly iQ	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.

Primary Outcome Measures

Name	Time	Method
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 observation of functioning systems	7 months	Proportion of Butterfly IQ systems functioning at end of study period
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 quality standards met (ANC)	7 months	Proportion of ANC visits (that included Butterfly IQ) found to meet quality standards

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Johns Hopkins Research Project; 🇲🇼 Blantyre, Malawi