Sonoclot to Evaluate Thrombotic Risk in Proteinuric Pregnancy

NCT05108389 | Unknown

• 1 other identifier: 19OB011
• Study Type: observational
• Target: 13
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Pregnancy Complications; Proteinuria in Pregnancy; Chronic Kidney Diseases; Venous Thromboembolism

Keywords

Pregnancy Proteinuria Thrombosis

Outcome Measures

Primary Outcomes (1)

• Proteinuria (log) to clot time correlation

  Univariate linear regression analysis of clot time vs log\[urine protein:creatinine ratio\]

  Through study completion, an average of 9 months

Secondary Outcomes (3)

• Proteinuria to clot time correlation

  Through study completion, an average of 9 months

• Proteinuria (<>100mg/mmol) to clot time correlation

  Through study completion, an average of 9 months

• Proteinuria (<>300mg/mmol) to clot time correlation

  Through study completion, an average of 9 months

Other Outcomes (1)

• Exploratory

  Through study completion, an average of 9 months

Study Arms (1)

Pregnant women with kidney disease

Pregnant women with kidney disease. No intervention.

Diagnostic Test: Viscoelastic haemostasis monitor output

Interventions

Viscoelastic haemostasis monitor output DIAGNOSTIC_TEST

Observational

Pregnant women with kidney disease

Eligibility Criteria

• Age: 18 Years - 55 Years
• Gender Eligibility Details: Pregnant women
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant women attending the combined renal-obstetric outpatient service at Nottingham University Hospitals NHS Trust, UK

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nottingham University Hospitals NHS Trust: lead

Study Sites (1)

Nottingham University Hospitals

Nottingham, NG5 1PB, United Kingdom

Location

MeSH Terms

Conditions

Pregnancy Complications; Renal Insufficiency, Chronic; Venous Thromboembolism

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Matthew Hall, MB MD FRCP

  Nottingham University Hospitals

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2021
• First Posted: November 4, 2021
• Study Start: March 1, 2022
• Primary Completion: July 1, 2023
• Study Completion: October 1, 2023
• Last Updated: April 6, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)