The Salurate Study: Validation of salivary uric monitoring for early prediction of hypertensive (high blood pressure) disorders of pregnancy
| ISRCTN | ISRCTN17992452 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17992452 |
| IRAS number | 337290 |
| Secondary identifying numbers | CPMS 61551, Grant Code 10053908, IRAS 337290 |
- Submission date
- 18/06/2024
- Registration date
- 08/07/2024
- Last edited
- 25/09/2024
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Pregnancy and Childbirth
Plain English Summary
Background and study aims
The Salurate study aims to validate a new method for monitoring uric acid levels in saliva to predict disorders of high blood pressure in pregnancy early. Hypertensive disorders, such as pre-eclampsia, are significant complications during pregnancy that can lead to severe health issues for both the mother and the baby. Early detection and management of these conditions are crucial for improving outcomes for both mum and baby. The study seeks to address current diagnostic limitations and enhance prenatal care by providing a non-invasive, easy-to-use tool for early risk assessment.
Who can participate?
The study targets pregnant women who meet specific inclusion criteria. Participants must be over 16 years old, less than 16 weeks pregnant with a singleton pregnancy and willing to provide saliva samples for testing. The exact inclusion and exclusion criteria are detailed in the protocol, ensuring that only eligible candidates are enrolled to maintain the study's integrity and reliability.
What does the study involve?
Participants in the Salurate study will undergo several steps:
1. Informed Consent: Before enrolling in the study, participants will be fully informed about the study's purpose, procedures, potential risks, and benefits. They will then sign a consent form to confirm their willingness to participate.
2. Saliva Sampling: Participants will provide saliva samples on a weekly basis. These samples will be collected using a specially designed Salurate system, which includes a swab, a test cartridge and a smartphone app. The app will capture an image of the test cartridge and transmit it to the study's central database.
3. Data Collection: Along with saliva samples, participants' clinical data will be collected and matched with their test results. This data will be encrypted and stored securely to ensure confidentiality.
4. Follow-Up: Participants will be monitored throughout their pregnancy to track any development of hypertensive disorders by their clinical team. There will be no additional participant visits for the purpose of the study. At the conclusion of pregnancy, outcomes will be collected from the medical notes.
What are the possible benefits and risks of participating?
Benefits:
- There are no direct benefits to the participants taking part. Their participation may benefit women in future pregnancies, who may benefit from early detection of hypertensive disorders, allowing for timely intervention and management.
Risks:
- Inconvenience: The primary risk involves the inconvenience of providing saliva samples. If the swab-taking process causes discomfort or injury, participants are advised to pause and contact a member of the study team.
Where is the study run from?
The study is sponsored by Morgan Innovation and Technology Ltd., with the primary research being conducted at St. George’s University Hospitals NHS Foundation Trust and Epsom and St. Helier University Hospitals NHS Trust. The study involves multiple sites to ensure a diverse participant pool and comprehensive data collection.
When is the study starting and how long is it expected to run for?
May 2023 to June 2026
Who is funding the study?
The study is funded by a grant from Innovate UK, a government agency that supports business-led innovation.
Who is the main contact?
Professor Baskaran Thilaganathan, basky@pobox.com
Contact information
Scientific, Principal Investigator
St. George's University Hospitals NHS Foundation Trust
London
SW17 0QT
United Kingdom
 ORCID ID |
0000-0002-5531-4301 |
|---|---|
| Phone | +44 7956561192 |
| basky@pobox.com |
Study information
| Study design | Multi-center observational analytical cohort |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Screening |
| Participant information sheet | ISRCTN17992452_PIS_V5_24Jul24.pdf |
| Scientific title | Validation of salivary uric monitoring for early prediction of hypertensive disorders of pregnancy |
| Study acronym | The Salurate Study |
| Study hypothesis | To assess whether the incorporation of the Salurate pregnancy remote self-monitoring system into the care pathway of pregnant women can enable the early prediction of hypertensive disorders of pregnancy (HDP) before the onset of clinical symptoms. |
| Ethics approval(s) |
Approved 05/08/2024, East of England – Cambridge East (2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; +44 207 104 8096; cambridgeeast.rec@hra.nhs.uk), ref: 24/EE/0123 |
| Condition | Salivary uric monitoring for early prediction of hypertensive disorders of pregnancy |
| Intervention | While waiting to have their first scan, potential participants will receive a copy of the Salurate study information leaflet. After the scan is done, potential participants will be assessed for an ASPRE risk (a HDP screening algorithm) to determine if women have a high, medium or low chance of developing HDP. The clinical team will emphasize the voluntary nature of participation and the participant's freedom to withdraw from the study at any time without affecting their regular care. It will be made clear to potential participants that there are no direct benefits to participating in this study, as the results will not be accessible to their clinical team, and no additional clinical intervention related to the trial will be carried out. After signing the consent form, the participant will be introduced to the sample kit. It will be made clear that the only procedure outside of standard antenatal practice is that once per week, at the same time and before drinking, eating, exercising, or teeth cleaning, the participant will take a saliva sample and apply it on a test paper (encapsulated in a test cartridge), which colour will change depending on the concentration of uric acid in women's saliva. Using the app developed for the trial, the Salurate app, they will be asked to take a picture of the test cartridge and upload it using the app. The picture will be sent to a secure server (cloud-based). Data related to pregnancy outcomes will equally be collected after delivery for the research team to analyse the outcomes of this trial. The results of this study are expected to provide valuable insights into the potential of the Salurate pregnancy remote self-monitoring system to predict HDP onset and enable proactive management. |
| Intervention type | Other |
| Primary outcome measure | Clinical diagnosis of hypertensive disorders of pregnancy, including gestational hypertension, pre-eclampsia and chronic hypertension with superimposed pre-eclampsia. Diagnoses will be in line with ISSHP definitions, and data will be collected at the conclusion of pregnancy. |
| Secondary outcome measures | Collected within 6 weeks of the conclusion of pregnancy: 1. Small for gestation age fetus or fetal growth restriction i.e. neonates whose birth weight is less than the 10th percentile for that particular gestational age or two standard deviations below the population norms on the growth charts. Fetal growth restrictions includes evidence of placental insufficiency e.g. abnormal antenatal fetal doppler measurements 2. Gestational diabetes, defined as any degree of glucose intolerance with onset or first recognition during pregnancy. Diagnosed by oral glucose tolerance test or home blood glucose monitoring 3. Sampling adherence, including frequency of missed samples, dropout rate and number of ‘dry’ samples received |
| Overall study start date | 31/05/2023 |
| Overall study end date | 30/06/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 16 Years |
| Sex | Female |
| Target number of participants | Planned Sample Size: 4,000; UK Sample Size: 4,000 |
| Participant inclusion criteria | 1. Women, 16 years old or over with a singleton pregnancy 2. Viable intrauterine pregnancy on the 10-14 week scan 3. High risk (≥1:100) of HDP as determined by the ASPRE [14] algorithm* 4. Medium risk of HDP as defined by an ASPRE risk between 1:100 and 1:300 5. Able to provide informed consent 6. Gestation at enrolment ≤16 weeks *Risk assessment based on: maternal factors, Mean Arterial Pressure, Uterine Artery Pulsatility Index, maternal serum pregnancy-associated plasma protein – A and placental growth factors |
| Participant exclusion criteria | 1. Any significant medical co-morbidities which may potentially interfere with participation in or achieving the objectives of the study 2. Presence or history of severe mental illness that means the participant is unable to use Salurate independently 3. Any significant learning disability that means the participant is unable to use Salurate independently 4. Educational status or language barrier that influences capacity to use the App or understand the IFUs 5. Women who are physically incapacitated such as to make manipulation of the sampling system uncomfortable or impractical, as judged by the recruiter 6. Women who do not have access to a smartphone and/or internet data at home 7. Women who have been diagnosed with severe gingivitis or periodontal disease 8. Women who have been diagnosed with oral cancer Contraindications 1. The potential participant suffers from severe nausea and vomiting in pregnancy. 2. The potential participant has infected, inflamed, cut/scraped or painful areas in their mouth. |
| Recruitment start date | 11/09/2024 |
| Recruitment end date | 28/11/2025 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
London
SW17 0QT
United Kingdom
Carshalton
SM5 1AA
United Kingdom
Sponsor information
Industry
Unit 17 Petersfield Business Park, Bedford Road
Petersfield
GU32 3QA
England
United Kingdom
| Phone | +44 1730895900 |
|---|---|
| Louise.Lough@morgan-iat.co.uk | |
| Website | https://morgan-iat.co.uk/ |
"ROR" |
https://ror.org/01vspgn73 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- innovateuk
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/12/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in publicly available repository, Available on request |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal |
| IPD sharing plan | The datasets generated during and analysed during the current study intend to be published in a publicly available repository once all future studies related to the Salurate device are completed and data has been published. Prior to this anonymised data is available on request by contacting the chief investigator directly, and appropriate datasets will be provided to interested parties. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version 5 | 24/07/2024 | 24/09/2024 | No | Yes |
| Protocol file | version 4 | 04/07/2024 | 24/09/2024 | No | No |
Additional files
Editorial Notes
25/09/2024: The recruitment start date was changed from 10/09/2024 to 11/09/2024. Protocol and participant information sheet replaced with new versions.
09/09/2024: The following changes were made to the trial record:
1. The ethics approval was added.
2. The recruitment start date was changed from 02/09/2024 to 10/09/2024.
18/06/2024: Trial's existence confirmed by the National Institute for Health and Care Research (NIHR) (UK).
