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Pregnancy RelatedFAB-IQNCT05054504

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.

Official record
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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

  1. Member of HC or hospital staff providing obstetric care.
  2. Able and willing to comply with all study requirements and complete all study procedures.
  3. 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:

  1. Member of HC or hospital staff providing obstetric care.
  2. Able and willing to comply with all study requirements and complete all study procedures.
  3. 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:

  1. Age 18 years or older at Screening, as verified per site Standard Operating Procedures (SOPs).
  2. At enrollment, present for first ANC visit.
  3. Able and willing to comply with all study requirements and complete all Phase 2 study procedures.
  4. Able and willing to provide informed consent to be screened for and to take part in Phase 2 of the study.
  5. 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:

  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.

Study participant - ANC Clients:

  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 3 Inclusion Criteria

  1. Participated in Phase 1 or 2 of the study or newly recruited stakeholder interested in development or implementation of obstetric ultrasound in Malawi.
  2. Able and willing to comply with all study requirements and complete all Phase 3 study procedures.
  3. 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

  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

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

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.

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.

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 groupRoleWhat they receive
InterventionOtherThe 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.

  1. Feasibility of the intervention by participant report

    Proportion of enrolled midwives who report the intervention to be feasible

    Measured: 7 months

  2. Feasibility of the intervention by quality standards met (ultrasound)

    Proportion of ultrasound examinations found to meet quality standards

    Measured: 7 months

  3. 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

  4. Feasibility of the intervention by observation of functioning systems

    Proportion of Butterfly IQ systems functioning at end of study period

    Measured: 7 months

  5. 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)

  1. Acceptability, by participant report (providers)

    Proportion of providers who find the intervention acceptable

    Measured: 7 months

  2. 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.

  1. First posted23 Sep 2021
  2. Study start6 Oct 2021
  3. Primary completion15 Mar 2024
  4. Study completion15 Mar 2024

Resources

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

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.

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