Sonoclot to Evaluate Thrombotic Risk in Proteinuric Pregnancy (NCT05108389) | Clinical Trial Compass
UnknownNot Applicable
Sonoclot to Evaluate Thrombotic Risk in Proteinuric Pregnancy
United Kingdom13 participantsStarted 2022-03-01
Plain-language summary
There is a lack of consensus on whether women with proteinuric kidney disease benefit from prophylactic anticoagulation during pregnancy to reduce the risk of venous thromboembolism.
This pilot study will investigate the feasibility of obtaining thrombosis profile data using a viscoelastic haemostasis monitor - Sonoclot - from pregnant women with kidney disease, and exploratory analyses to elucidate correlations between output values and clinical parameters
Who can participate
Age range
18 Years – 55 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Confirmed pregnancy by ultrasound scanning or urine or serum beta-HCG
* Chronic kidney disease stage 1 to 5, defined as abnormalities of serum creatinine, urine constituents or renal tract anatomy for more than 3 months, or genetic traits associated with renal disease
Exclusion Criteria:
* Known primary thrombophilia (including factor V Leiden, prothrombin mutations, protein C deficiency, protein S deficiency)
* Treatment with low molecular weight heparin in 24 hours prior to consent
* Suspected or confirmed active pre-eclampsia or superimposed pre-eclampsia
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proteinuria (log) to clot time correlation
Timeframe: Through study completion, an average of 9 months