Creatine kinase, platelet aggregation, and bleeding risk in women with uterine leiomyomas
- Conditions
- heavy menstrual bleeding1003553410038595menorrhagia
- Registration Number
- NL-OMON43648
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 32
Main study:
20 premenopausal women aged 18-50 years, visiting the gynaecology outpatient clinic with uterine leiomyomas and heavy menstrual bleeding, and women without leiomyomas and normal menstrual bleeding, forming the control group. ;Pilot study:
12 premenopausal female volunteers, 18-50 years:
a. 8 women with heavy menstrual blood loss;
- without treatment for the menstrual blood loss (n=2)
- with plasmin inhibitor treatment for the menstrual blood loss (n=2)
- with DOAC-induced heavy menstrual blood loss (n=2)
- with VKA-induced heavy menstrual blood loss (n=2);
b. 2 women normal menstrual blood loss;
c. 2 women postpartum.
Main study:
Smoking, usage of NSAID, antiplatelet drugs and anticoagulants, hormone therapy or hormone supplements in 4 weeks prior to participation. Usage of CK-increasing drugs, such as statins, in the three months prior to participation. Glucose, lipid spectrum, thyroid, kidney or liver abnormalities, no history of secondary hypertension, (history of) cardiovascular disease including TIA and stroke; neuromuscular or endocrine disorders; vasculitis; HIV infection; malignancies; infectious hepatitis, bleeding disorders (other than heavy menstrual bleeding). ;Pilot study:
Usage of CK-increasing drugs, such as statins, in the three months prior to participation. Glucose, lipid spectrum, thyroid, kidney or liver abnormalities, neuromuscular or endocrine disorders; HIV infection; infectious hepatitis, bleeding disorders (other than heavy menstrual bleeding).
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The association between plasma CK activity, ADP-dependent platelet aggregation,<br /><br>and bleeding severity in women with uterine leiomyomas.<br /><br><br /><br>Pilot study parameters/endpoints:<br /><br>Firstly, the feasibility and optimal strategy of CK and AK activity measurement<br /><br>menstrual and postpartum vaginal blood). Secondly, to assess the relation<br /><br>between vaginally lossed blood CK/AK activity, venous plasma CK/AK activity and<br /><br>bleeding severity. Thirdly, the concentration of DOAC and VKA in menstrual<br /><br>blood.</p><br>
- Secondary Outcome Measures
Name Time Method