heavy menstrual bleeding menorrhagia
Conditions
Interventions
creatine kinase
platelet aggregation
uterine leiomyomas
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The association between plasma CK activity, ADP-dependent platelet aggregation, and bleeding severity in women with uterine leiomyomas. Pilot study parameters/endpoints: Firstly, the feasibility and optimal strategy of CK and AK activity measurement menstrual and postpartum vaginal blood). Secondly, to assess the relation between vaginally lossed blood CK/AK activity, venous plasma CK/AK activity and bleeding severity. Thirdly, the concentration of DOAC and VKA in menstrual blood. | — |
Secondary
| Measure | Time frame |
|---|---|
| - To assess menstrual bleeding severity (Hb, amount of menstrual blood loss using the visual Pictorial Blood loss Assessment Chart (PBAC) score) in patients with uterine leiomyomas and controls in relation to CK . - To assess whether measures of the volume of the neoplasms (the diameter of the largest fibroid and the number of fibroids) are related to CK, ADP-dependent platelet aggregation, and bleeding risk. - Assessing whether the bleeding risk questionnaire score (see Appendix Bloedingen vragenlijst, in Dutch) is related to the presence and extent of the heavy menstrual blood loss, CK and ADP-induced platelet aggregation. - Assessing CK activity, hemoglobuline and sodium concentration in menstrual blood. This, to establish whether the CK activity in menstrual blood is high and thus may locally attenuate ADP-induced platelet aggregation, and whether the CK activity in menstrual blood is composed of CK derived from intravascular blood (mainly the CKMM isotype) or CK derived from uterine smooth muscle tissue (mainly the CKBB isotype). | — |
Countries
The Netherlands
Outcome results
None listed