Bleeding Disorder, Heavy Menstrual Bleeding
Conditions
Keywords
heavy menstrual bleeding, bleeding disorder, adolescent, contraception, menstrual management
Brief summary
The goal of this study is to evaluate whether hormonal medications (such as contraceptive pill, patch, injectable progestins and hormonal intra-uterine device) have similar efficacy at managing heavy menstrual bleeding in adolescents with a bleeding disorder compared to those without. We also aim to assess the quality of life and hemoglobin and iron levels in this population.
Detailed description
Adolescents with heavy menstrual bleeding and willing to start a hormonal medication to reduce menstrual flow are included. At baseline and during the study period, questionnaires and blood tests are performed. Adolescents with a bleeding disorder are compared to those without. Follow-up is 1 year.
Interventions
None listed
Sponsors
University Hospital, Geneva
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
No minimum to 25 Years
Healthy volunteers
No
Inclusion criteria
* Adolescents and young adults aged \< 26yo * Presenting to the gynecology consultation at HUG * Diagnosed with heavy menstrual bleeding (PBAC \> 100) * Willing to initiate a hormonal medication to manage heavy menstrual bleeding
Exclusion criteria
* Pregnancy or planning to become pregnant during the study period * Already using hormonal medication for menstrual management and/or contraception * Known anatomical uterine pathology * Using anticoagulant or antiaggregant agents
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of reduction in menstrual blood loss | 6 months after hormonal medication initiation | Using PBAC (pictorial blood loss assessment chart) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of reduction in menstrual blood loss | 3 months following hormonal medication initiation | Using PBAC |
| Quality of life | at baseline, 3 months, 6 months and 12 months | QoL (measured by the Pediatric Quality of Life Inventory (PedsQL) for adolescents (13-18 years old) or young adults (19-25 years old)) ; range 0-100 with higher scores representing better quality of life. |
| Hemoglobin and ferritin levels changes | at baseline, 6 months and 12 months | Blood samples to measure hemoglobin and ferritin |
| Changes in thrombin generation markers | at baseline and 6 months | Blood sample |
Countries
Switzerland
Contacts
CONTACTDehlia Moussaoui, MD
Outcome results
None listed