A study evaluating a new digital tool for early pregnancy risk assessment in primary care
| ISRCTN | ISRCTN53486570 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN53486570 |
| Integrated Research Application System (IRAS) | 343982 |
| Sponsor | First 4 Health Group |
| Funder | SBRI Healthcare |
- Submission date
- 05/07/2026
- Registration date
- 18/08/2026
- Last edited
- 21/07/2026
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Plain English summary of protocol
Background and study aims
Some people have physical, mental health, or social circumstances that increase their chance of developing complications during pregnancy. Finding these risk factors as early as possible can help healthcare professionals provide the right care, support and referrals. However, many pregnant people do not have their first hospital maternity appointment until several weeks after they discover they are pregnant.
For many people, their GP practice is the first healthcare service they contact when they become pregnant. This study will evaluate a new digital tool called MpRisk, which is designed to help healthcare professionals identify people who may need additional support as early as possible. MpRisk reviews information that is already recorded in the patient's GP medical record and highlights factors that may increase the risk of complications during pregnancy. The tool is designed to support healthcare professionals and does not replace their clinical judgement or routine maternity care.
Who can participate?
Pregnant people aged 16 to 51 years who are registered with one of the participating GP practices and notify their GP that they are pregnant can take part. People who have chosen not to allow their GP data to be used for research (Type 1 Opt-out) will not be included.
What does the study involve?
Around 300 pregnant people will take part across five GP practices in London. Some practices will use MpRisk as part of their routine assessment when a pregnancy is reported, while the remaining practices will continue to provide their usual care without the tool.
Healthcare professionals using MpRisk will receive a summary of any identified pregnancy risks based on information already held in the patient's GP record. This may help them decide whether additional assessment, referral or support would be helpful. Clinical researchers will compare the two groups to see how well pregnancy risks are identified and will also ask healthcare professionals about their experiences of using the software.
What are the possible benefits and risks of participating?
The study may help identify pregnancy risks earlier, allowing healthcare professionals to offer more personalised care and support.
The risks are expected to be very low because MpRisk only analyses information that is already recorded in medical records. It does not replace routine care, and all clinical decisions remain the responsibility of the healthcare professional.
Where is the study run from?
The study is being carried out at five GP practices in London, England, and is sponsored by First 4 Health Group (UK)
When is the study starting and how long is it expected to run for?
January 2025 to August 2025
Who is funding the study?
SBRI Healthcare (UK)
Who is the main contact?
Dr Kendra Wong, kendra.wong@nhs.net
Contact information
Principal investigator, Scientific, Public
First 4 Health Group - Church Road Health
1st Floor, The Centre Manor Park, 30 Church Road
London
E12 6AQ
United Kingdom
| Phone | +44 (0)2033259888 |
|---|---|
| kendra.wong@nhs.net |
Principal investigator
First 4 Health Group - E7 Health
121 Woodgrange Rd
London
E7 0EP
United Kingdom
| Phone | +44 (0)2085341026 |
|---|---|
| n.ahuja@nhs.net |
Scientific
Ellescope
71-75 Shelton Street
London
WC2H 9JQ
United Kingdom
 ORCID ID |
0009-0000-0264-959X |
|---|---|
| Phone | +44 (0)2085344133 |
| sandra@ellescope.com |
Study information
| Primary study design | Interventional |
|---|---|
| Allocation | Non-randomized controlled trial |
| Masking | Open (masking not used) |
| Control | Active |
| Assignment | Parallel |
| Purpose | Device feasibility, Screening |
| Scientific title | Cluster controlled clinical trial evaluating a novel digital antenatal risk-assessment software for early identification of pregnancy risks in primary care |
| Study objectives | |
| Ethics approval(s) |
Approved 03/01/2025, London - London Bridge Research Ethics Committee (2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; +44 (0)20 7104 8222; londonbridge.rec@hra.nhs.uk), ref: 24/LO/0857 |
| Health condition(s) or problem(s) studied | Pregnancy, with assessment of clinical, mental health, and social risk factors associated with adverse maternal and perinatal outcomes |
| Intervention | MpRisk is a digital antenatal risk assessment and clinical decision support software used at the point of pregnancy notification in primary care. When a pregnant individual notifies their GP practice of their pregnancy, the software analyses routinely collected demographic, clinical, mental health, and social information to identify and stratify individuals according to their risk of adverse maternal outcomes. The software generates a risk profile to support healthcare professionals in the early identification of individuals who may benefit from enhanced assessment, referral, or tailored care. MpRisk is used alongside existing clinical pathways and local standard practice and does not replace routine antenatal care or clinical decision-making. The purpose of the intervention is to facilitate earlier recognition of bio-psychosocial risk factors and support timely, needs-based care during pregnancy. |
| Intervention type | Device |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | MpRisk |
| Primary outcome measure(s) |
|
| Key secondary outcome measure(s) |
|
| Completion date | 29/08/2025 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Mixed |
| Lower age limit | 16 Years |
| Upper age limit | 51 Years |
| Sex | Female |
| Target sample size at registration | 300 |
| Total final enrolment | 300 |
| Key inclusion criteria | Pregnant individuals aged 16–51 years who are registered at the study site and are identified following notification of their pregnancy to their GP practice |
| Key exclusion criteria | Individuals with a recorded Type 1 Opt-out in their GP record are automatically excluded from the study |
| Date of first enrolment | 03/01/2025 |
| Date of final enrolment | 04/07/2025 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centres
London
E12 6AQ
England
Stratford
London
E15 4BZ
England
London
E7 0EP
England
London
E13 8RU
England
40 Liberty Bridge Road
Stratford
London
E20 1AS
England
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|
Editorial Notes
06/07/2026: Study's existence confirmed by the London - London Bridge Research Ethics Committee.
