Can pocket-sized ultrasound devices be used safely and acceptably in routine pregnancy care?
| ISRCTN | ISRCTN90806640 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN90806640 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Integrated Research Application System (IRAS) | 351278 |
| Protocol serial number | UoL001929 |
| Sponsor | University of Liverpool |
| Funder | Liverpool Women's NHS Foundation Trust |
- Submission date
- 27/08/2025
- Registration date
- 28/08/2025
- Last edited
- 28/08/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Pregnancy and Childbirth
Plain English summary of protocol
Background and study aims
Ultrasound scans are an important part of pregnancy care and are used to check the baby’s growth and wellbeing. Standard ultrasound machines are large, costly, and need specialist staff. New hand-held ultrasound devices are smaller, cheaper, and easier to use, but we do not yet know if they are reliable enough or acceptable to pregnant people. This study aims to find out whether it is practical to run a larger trial in the future and whether people are happy to have this type of scan.
Who can participate?
Pregnant people aged 18 years or over who are attending Liverpool Women’s Hospital for routine care, such as monitoring for diabetes, small or suspected small babies, or reduced fetal movements.
What does the study involve?
Participants will be asked to have an additional ultrasound scan using a hand-held device during their routine appointment, alongside the standard scan already planned. Afterwards, they will complete a short questionnaire about their experience.
What are the possible benefits and risks of participating?
Participants will be offered a scan picture of their baby, if position allows. Their involvement may help improve pregnancy care in the future. There are no known risks from the extra scan, as ultrasound is considered safe in pregnancy.
Where is the study run from?
The study is being run at Liverpool Women’s Hospital NHS Foundation Trust, supported by the University of Liverpool (UK)
When is the study starting and how long is it expected to run for?
January 2025 to August 2026
Who is funding the study?
The study is supported in kind by Liverpool Women’s Hospital, which is providing the salary of the principal investigator. No external grant funding has been received.
Who is the main contact?
Dr Kelsey Lennox, kelsey.lennox@nhs.net
Contact information
Public, Scientific, Principal investigator
Liverpool Women's Hospital
Liverpool
L8 7SS
United Kingdom
 ORCID ID |
0009-0004-9782-9030 |
|---|---|
| Phone | +44 (0)151 708 9988 |
| kelsey.lennox@nhs.net |
Public, Scientific, Principal investigator
Liverpool Women's Hospital
Liverpool
L8 7SS
United Kingdom
| ORCID ID |
0000-0003-2802-7670 |
|---|---|
| Phone | +44 (0)151 708 9988 |
| asma.khalil@lwh.nhs.uk |
Public, Scientific, Principal investigator
Liverpool Women's Hospital
Liverpool
L8 7SS
United Kingdom
| ORCID ID |
0000-0003-0352-2106 |
|---|---|
| Phone | +44 (0)151 708 9988 |
| abi.merriel@liverpool.ac.uk |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Single-centre observational feasibility study with mixed quantitative and qualitative methods |
| Secondary study design | Cohort study |
| Participant information sheet | 47902_PIS_V1.1_08Aug2025.pdf |
| Scientific title | Routine Use of Focussed UltraSound in Antenatal Fetal Imaging (RUFUS-AFI) |
| Study acronym | RUFUS-AFI |
| Study objectives | This study aims to assess whether small hand-held ultrasound devices can be reliably and acceptably used alongside standard ultrasound scans in pregnancy care. The main objectives are to: 1. Explore whether it is feasible to run a larger trial comparing hand-held ultrasound with standard ultrasound in antenatal care. 2. Assess how acceptable hand-held ultrasound is to pregnant people. 3. Test whether the measurements obtained from hand-held ultrasound are reliable compared with standard scans. 4. Identify any practical issues, such as time taken or ease of use, that might affect future studies. |
| Ethics approval(s) |
Approved 22/08/2025, Fulham Research Ethics Committee (Health Research Authority, 2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; +44 (0)207 104 8340; Fulham.rec@hra.nhs.uk), ref: 25/PR/0942 |
| Health condition(s) or problem(s) studied | Antenatal care in pregnancy, including people with diabetes, suspected small-for-gestational-age (SGA) babies, or reduced fetal movements |
| Intervention | Use of a hand-held point-of-care ultrasound device alongside routine standard ultrasound in pregnancy care. |
| Intervention type | Device |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Vscan Air |
| Primary outcome measure(s) |
1. Feasibility and acceptability of using hand-held ultrasound in pregnancy, measured throughout the study period (up to 24 months). Specific indicators: |
| Key secondary outcome measure(s) |
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. |
| Completion date | 31/08/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target sample size at registration | 180 |
| Key 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 |
| Key exclusion criteria | 1. Inability to provide informed consent 2. Patients who have an abnormal CTG necessitating urgent delivery, or in established preterm labour |
| Date of first enrolment | 29/08/2025 |
| Date of final enrolment | 31/08/2026 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Crown Street
Liverpool
L8 7SS
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Stored in publicly available repository |
| IPD sharing plan | Will IPD be shared? Yes, but only fully anonymised data. What type of data will be shared? Anonymised quantitative data from ultrasound scans (fetal biometry, presentation, placentation, viability), basic maternal characteristics relevant to scan feasibility (e.g. BMI, smoking status, diabetes, hypertensive disease, fibroid uterus, generalised categories of medical history), and questionnaire responses on acceptability. No ultrasound images, identifiable information, or consent forms will be shared. When will the data become available and for how long? Anonymised datasets will be made available after study completion, once data are cleaned, locked, and published (anticipated 2027). Data will be retained and accessible for a minimum of 10 years, in line with University of Liverpool and Sponsor policy. Where will the data be available? Data will be deposited in the University of Liverpool Data Catalogue (DataCat), with a DOI assigned, and may also be made available as supplementary material to publications. Access criteria and with whom will data be shared? Data will be openly available under a Creative Commons Attribution (CC-BY) licence, allowing reuse with appropriate citation. Researchers and clinicians may use the data for secondary analyses relating to ultrasound in pregnancy. How will data be anonymised? All identifiers (name, date of birth, hospital/NHS numbers) will be removed. Maternal health conditions will be recorded only in broad categories to avoid rare disease identification. Ultrasound images will be deleted at study closure and not shared. Ethical/legal considerations Participants provide informed consent that anonymised data may be shared for future research. Data management follows GDPR and University of Liverpool data governance policies. Pseudonymised and identifiable data will remain confidential and stored securely for 10 years, after which they will be destroyed. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version 1.1 | 08/08/2025 | 28/08/2025 | No | Yes |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Protocol file | version 1.1 | 08/08/2025 | 28/08/2025 | No | No |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
Additional files
- 47902_PIS_V1.1_08Aug2025.pdf
- Participant information sheet
- 47902_PROTOCOL_V1.1_08Aug2025.pdf
- Protocol file
Editorial Notes
27/08/2025: Study's existence confirmed by the HRA.
