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Can pocket-sized ultrasound devices be used safely and acceptably in routine pregnancy care?

Routine Use of Focussed UltraSound in Antenatal Fetal Imaging (RUFUS-AFI)

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN90806640
Enrollment
180
Registered
2025-08-28
Start date
2025-10-10
Completion date
Unknown
Last updated
2026-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Antenatal care in pregnancy, including people with diabetes, suspected small-for-gestational-age (SGA) babies, planned caesarean birth, or reduced fetal movements. Healthcare professionals in Maternity settings Pregnancy and Childbirth

Interventions

Use of a hand-held point-of-care ultrasound device alongside routine standard ultrasound in pregnancy care.

Sponsors

University of Liverpool
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: Pregnant patients attending Liverpool Women’s Hospital for one or more of the following indications: 1. Routine assessment of the fetus due to maternal diabetes 2. Routine assessment of SGA fetus 3. Assessment of suspected SGA fetus on symphysis-fundal height measurement (SFH) 4. Reduced fetal movements 5. Able and willing to provide informed written consent for participation in the study 6. Aged 18 years or above Added 27/01/2026: UK healthcare professionals working in maternity care, or worked in maternity care <5 years ago

Exclusion criteria

Exclusion criteria: 1. Inability to provide informed consent 2. Patients who have an abnormal CTG necessitating urgent delivery, or in established preterm labour Added 27/01/2026: 3. Healthcare professionals retired or out of clinical practice >5 years

Design outcomes

Primary

MeasureTime frame
1. Feasibility and acceptability of using hand-held ultrasound in pregnancy, measured throughout the study period (up to 24 months). Specific indicators: 1.1. Recruitment rate (number and proportion of eligible participants recruited, at baseline) 1.2. Questionnaire completion rate (measured at the end of each participant’s study involvement, at baseline) 1.3. Willingness to undergo future hand-held scans (reported immediately after the scan via questionnaire, at baseline) 1.4. Number of unblinding episodes (recorded prospectively during scanning session, at baseline)

Secondary

MeasureTime frame
1. Reliability of fetal biometry (head circumference, abdominal circumference, femur length, estimated fetal weight), assessed at the participant’s study scan (at baseline), using intraclass correlation coefficients (ICC) and Bland–Altman plots. 2. Reliability of amniotic fluid volume and presentation recorded at the study scan (at baseline), using Kappa statistics. 3. Efficiency of scanning, measured as time taken (minutes) to complete hand-held ultrasound, recorded during each participant’s study scan (at baseline). 4. Feasibility of measurement, recorded at the study scan (at baseline) as the proportion of participants in whom full biometric assessment could not be completed with the hand-held device. 5. Acceptability to participants, measured immediately after the scan (at baseline) by questionnaire responses on satisfaction and willingness to undergo future scans.

Countries

England, United Kingdom

Contacts

Public ContactKelsey;Asma Lennox;Khalil

;

kelsey.lennox@nhs.net;asma.khalil@lwh.nhs.uk+44 (0)151 708 9988;+44 (0)151 708 9988

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 15, 2026