Risico op en oorzaken van abnormaal menstrueel bloedverlies in vrouwelijke proefpersonen in de vruchtbare leeftijd met trombosebeen of longembolie
Recruiting
- Conditions
- Venous thromboembolismMenstrual bleedingAnticoagulation
- Registration Number
- NL-OMON24079
- Lead Sponsor
- niversity of Leiden
- Brief Summary
one
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 210
Inclusion Criteria
Consecutive female patients between the ages of 18 and 50 with child bearing potential and objectivated, symptomatic VTE, who fulfil all the inclusion criteria and meet none of the exclusion criteria, are eligible for inclusion.
Exclusion Criteria
1)Woman between the ages of 18 and 50 who were subjected to hysterectomy or chemically induced menopause;
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of new-onset abnormal menstrual bleeding
- Secondary Outcome Measures
Name Time Method 1)Rate of clinical relevant non-major and major (menstrual) bleeding according to the ISTH criteria;<br /><br>2)Change in rate of abnormal menstrual bleeding after diagnosis of VTE after initiation of anticoagulants, and during the follow-up period;<br /><br>3)Impact of new-onset abnormal menstrual bleeding on QoL as assessed with the MBQ, VEINS-QOL and PEmb-QoL;<br /><br>4)Predictors of new-onset abnormal menstrual bleeding;<br /><br>5)Changes in contraceptive measures during the study: details, incidence, causes and effect on primary endpoint and recurrent VTE;<br /><br>6)Changes in anticoagulation therapy: details, incidence, causes and effect on primary endpoint and recurrent VTE; <br /><br>7)Presence of underlying gynaecological or other morbidities as explanation for abnormal menstrual bleeding.