Clinical trial · Observational
Are Uterine Fibroids Pro-thrombotic?
Does the Presence of Uterine Fibroids Cause Changes in the Blood That Increase the Risk of Clots?
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study will investigate whether the presence of uterine fibroids is independently associated with a laboratory defined pro-thrombotic phenotype. VTE is associated with significant mortality and morbidity. In addition, treating patients with UF and thrombosis represents a particular challenge as fibroids frequently cause menorrhagia, which is exacerbated by anticoagulation. It is therefore important to recognise and detect risk factors and prevent thrombosis wherever possible. If a pro-thrombotic phenotype is detected in patients with UF as their sole risk factor, then this could justify a new approach to the assessment and risk-management of a very large number of patients and could translate into a reduction in both morbidity and mortality for affected patients.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leiomyoma, Uterine | Uterine Corpus Leiomyoma | ALIAS | 0.90 |
| Thrombosis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Comparison of blood samples between the two groups | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- label
- 1
- description
- Women with uterine fibroids, not requiring any medical or surgical treatment.
- interventionNames
- Other: Comparison of blood samples between the two groups
- label
- 1a
- description
- Women with uterine fibroids undergoing myomectomy or hysterectomy for uterine fibroids
- label
- Group 2
- description
- Women with no uterine fibroids or uterine pathology on ultrasound scan
- interventionNames
- Other: Comparison of blood samples between the two groups
Primary outcomes (1)
- measure
- Assess for the presence of a laboratory pro-thrombotic phenotype in patients with UF
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: Group 1: 35 patients with ultrasound confirmed uterine fibroids. Group 1a: 35 patients with ultrasound confirmed uterine fibroids requiring myomectomy or hysterectomy. Group 2: 35 control patients with a normal pelvis on ultrasound Able to provide informed consent Exclusion Criteria:• Personal history of thrombosis * Pregnant * Post- partum (within 6 weeks) * Surgery within 90 days * Family history of thrombosis (first degree relative) * Co-morbidities: cancer, liver impairment, renal impairment, uncontrolled hypertension * Medication: Oral contraception containing oestrogen, hormone replacement therapy with oral oestrogen, antiplatelet therapy, anticoagulation * Tranexamic Acid within last 48hrs, Zoladex within the last 33 days * Smoker * If anaemia (Hb \<110 g/L) is demonstrated on the study sample taken
References
Publications (0)
Data not yet available