Feasibility and Acceptability of Butterfly iQ

Pregnancy Related Clinical Trial

— FAB-IQ  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05054504
• Other study ID #: ARC-005
• Status: Completed
• Phase: N/A
• Start date: October 6, 2021
• Est. completion date: March 15, 2024

Study information

• Verified date: April 2024
• Source: Jhpiego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 pregnancies.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1575
• Est. completion date: March 15, 2024
• Est. primary completion date: March 15, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pregnancy Related

Intervention

Device:
• Butterfly iQ
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.

Locations

Country	Name	City	State
Malawi	Johns Hopkins Research Project	Blantyre

Sponsors (5)

Lead Sponsor	Collaborator
Jhpiego	Bill and Melinda Gates Foundation, Johns Hopkins Bloomberg School of Public Health, Kamuzu University of Health Sciences, Ministry of Health, Malawi

Country where clinical trial is conducted

Malawi, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Gestational age at first ANC contact	Median gestational age at first ANC contact	7 months
Other	Number and types of suspected and confirmed higher-risk conditions identified by ultrasound and recorded in study records	Numbers of the following; Ectopic pregnancy; Multiple gestation; Abnormal placentation; Intrauterine fetal demise; Abnormalities of amniotic fluid, e.g., oligohydramnios, polyhydramnios; Fetal anomaly; Other condition not specified above	7 months
Primary	Feasibility of the intervention by participant report	Proportion of enrolled midwives who report the intervention to be feasible	7 months
Primary	Feasibility of the intervention by quality standards met (ultrasound)	Proportion of ultrasound examinations found to meet quality standards	7 months
Primary	Feasibility of the intervention by quality standards met (ANC)	Proportion of ANC visits (that included Butterfly IQ) found to meet quality standards	7 months
Primary	Feasibility of the intervention by observation of functioning systems	Proportion of Butterfly IQ systems functioning at end of study period	7 months
Primary	Feasibility of the intervention by observation of environments of care	Proportion of participating HC with facilitative environments of care	7 months
Secondary	Acceptability, by participant report (providers)	Proportion of providers who find the intervention acceptable	7 months
Secondary	Acceptability, by participant report (ANC clients)	Proportion of ANC clients who find the intervention acceptable	7 months