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Contact Information:

Prof Basky Thilaganathan
+44 7956561192
basky@pobox.com


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Be Part of Research - Trial Details - The Salurate Study: Validation of salivary uric monitoring for early prediction of hypertensive (high blood pressure) disorders of pregnancy
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The Salurate Study: Validation of salivary uric monitoring for early prediction of hypertensive (high blood pressure) disorders of pregnancy

Recruiting

Open to: Female

Age: Adult

Carshalton London

Medical Conditions

Salivary uric monitoring for early prediction of hypertensive disorders of pregnancy

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


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.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

11 Sep 2024 28 Nov 2025

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.


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.

You can take part if:



You may not be able to take part if:


1. Any significant medical co-morbidities which may potentially interfere with participation in or achieving the objectives of the study2. Presence or history of severe mental illness that means the participant is unable to use Salurate independently3. Any significant learning disability that means the participant is unable to use Salurate independently4. Educational status or language barrier that influences capacity to use the App or understand the IFUs5. Women who are physically incapacitated such as to make manipulation of the sampling system uncomfortable or impractical, as judged by the recruiter6. Women who do not have access to a smartphone and/or internet data at home7. Women who have been diagnosed with severe gingivitis or periodontal disease8. Women who have been diagnosed with oral cancer

Contraindications1. 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.


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • St Helier Hospital
    Wrythe Lane
    Carshalton
    SM5 1AA
  • St George's Hospital (tooting)
    Blackshaw Road
    London
    SW17 0QT

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.

Prof Basky Thilaganathan
+44 7956561192
basky@pobox.com



The study is sponsored by Morgan Innovation and Technology (United Kingdom) and funded by Innovate UK.



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Read full details for Trial ID: ISRCTN17992452

Or CPMS 61551

Last updated 25 September 2024

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