Feasibility and Acceptability of Butterfly iQ

A study testing Butterfly iQ in people with Pregnancy Related, run by Jhpiego at 1 site in Malawi.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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… Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Pregnancy Related
What is being tested?: Butterfly iQ
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,575 participants
Where: 1 siteMalawi
Study dates: 6 Oct 2021to 15 Mar 2024
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

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

Trial locations and contacts

1 site in 1 country.

Malawi1 site

Johns Hopkins Research Project
Blantyre

Other trials in Malawi

About this study

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

Read the 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
Being tested: Butterfly iQ
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

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Butterfly iQDevice
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.

Study groups in NCT05054504
Study group	Role	What they receive
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. Receives: Device: Butterfly iQ

What is being measured

The primary outcome is the main question the study is designed to answer.

Feasibility of the intervention by participant report
Proportion of enrolled midwives who report the intervention to be feasible
Measured: 7 months
Feasibility of the intervention by quality standards met (ultrasound)
Proportion of ultrasound examinations found to meet quality standards
Measured: 7 months
Feasibility of the intervention by quality standards met (ANC)
Proportion of ANC visits (that included Butterfly IQ) found to meet quality standards
Measured: 7 months
Feasibility of the intervention by observation of functioning systems
Proportion of Butterfly IQ systems functioning at end of study period
Measured: 7 months
Feasibility of the intervention by observation of environments of care
Proportion of participating HC with facilitative environments of care
Measured: 7 months

Secondary outcomes (2)

Acceptability, by participant report (providers)
Proportion of providers who find the intervention acceptable
Measured: 7 months
Acceptability, by participant report (ANC clients)
Proportion of ANC clients who find the intervention acceptable
Measured: 7 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Oct 202115 Mar 2024

First posted23 Sep 2021
Study start6 Oct 2021
Primary completion15 Mar 2024
Study completion15 Mar 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Health services research
Allocation: Not applicable
Intervention model: Single group
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.
Masking: None (open label)
Enrolment: 1,575 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05054504
Sponsor's protocol ID: ARC-005
Acronym: FAB-IQ
Status last verified: Apr 2024
First submitted: 4 Sep 2021
Last updated: 9 Apr 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 9 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Integration of Butterfly iQ Point of Care Ultrasound Into Antenatal Care in Blantyre, Malawi: A Feasibility and Acceptability Study
ClinicalTrials.gov ID: NCT05054504
Acronym / sponsor ID: FAB-IQ / ARC-005
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
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,575 participants (actual)
Lead sponsor: JhpiegoUniversity, hospital or other
Collaborators: Bill and Melinda Gates Foundation, Johns Hopkins Bloomberg School of Public Health, Kamuzu University of Health Sciences, Ministry of Health, Malawi
Study start: 6 Oct 2021 (actual)
Primary completion: 15 Mar 2024 (actual)
Study completion: 15 Mar 2024 (actual)
First posted: 23 Sep 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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.

Study design

Primary purpose: Health services research
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
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.

Arm	Type	Receives
Intervention	Other	Device: Butterfly iQThe 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Butterfly iQThe 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.	Device	Intervention

Primary outcome

Feasibility of the intervention by participant report
Time frame: 7 months
Proportion of enrolled midwives who report the intervention to be feasible
Feasibility of the intervention by quality standards met (ultrasound)
Time frame: 7 months
Proportion of ultrasound examinations found to meet quality standards
Feasibility of the intervention by quality standards met (ANC)
Time frame: 7 months
Proportion of ANC visits (that included Butterfly IQ) found to meet quality standards
Feasibility of the intervention by observation of functioning systems
Time frame: 7 months
Proportion of Butterfly IQ systems functioning at end of study period
Feasibility of the intervention by observation of environments of care
Time frame: 7 months
Proportion of participating HC with facilitative environments of care

2 secondary outcomes

Acceptability, by participant report (providers)
Time frame: 7 months
Acceptability, by participant report (ANC clients)
Time frame: 7 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2024.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Lisa M Noguchi, PhD, MSN study director

Jhpiego, Johns Hopkins University

Linly Seyama principal investigator

University of Malawi College of Medicine, JHP Blantyre

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Butterfly iQ in people with Pregnancy Related, run by Jhpiego at 1 site in Malawi.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Malawi. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility of the intervention by participant report (time frame: 7 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05054504.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2024.