Feasibility and Acceptability of Butterfly iQ

NCT05054504 | Completed FDA Device

• 1 other identifier: ARC-005
• Study Type: interventional
• Target: 1,575
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy Related

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

Outcome Measures

Primary Outcomes (5)

• 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

Secondary Outcomes (2)

• Acceptability, by participant report (providers)

  7 months

• Acceptability, by participant report (ANC clients)

  7 months

Other Outcomes (2)

• 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

  7 months

Study Arms (1)

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.

Device: Butterfly iQ

Interventions

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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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:
• 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.
• 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
• Participated in Phase 1 or 2 of the study or newly recruited stakeholder interested in development or implementation of obstetric ultrasound in Malawi.

Sponsors & Collaborators

• Jhpiego: lead
• Bill and Melinda Gates Foundation: collaborator
• Johns Hopkins Bloomberg School of Public Health: collaborator
• Kamuzu University of Health Sciences: collaborator
• Ministry of Health, Malawi: collaborator

Study Sites (1)

Johns Hopkins Research Project

Blantyre, Malawi

Location

Study Officials

• Lisa M Noguchi, PhD, MSN

  Jhpiego, Johns Hopkins University

  STUDY DIRECTOR

• Linly Seyama

  University of Malawi College of Medicine, JHP Blantyre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 4, 2021
• First Posted: September 23, 2021
• Study Start: October 6, 2021
• Primary Completion: March 15, 2024
• Study Completion: March 15, 2024
• Last Updated: April 9, 2024

Record last verified: 2024-04

Locations

MA (1)