Characterizing the Impact and Treatment of Reproductive Tract Bleeding on Women and Post-menarchal Girls With Bleeding Disorders
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|ClinicalTrials.gov Identifier: NCT03834727|
Recruitment Status : Enrolling by invitation
First Posted : February 8, 2019
Last Update Posted : February 8, 2019
Characterizing the impact and treatment of reproductive tract bleeding on women and post-menarchal girls with bleeding disorders.
Objectives: This is a cross-sectional observational study of women and girls (WG) with bleeding disorders enrolled in the American Thrombosis and Hemostasis Network (ATHN) dataset. Based on the investigators' study of currently available data of WG with bleeding disorders in the ATHNdataset, the investigators hypothesize that the information currently captured in the core data elements of the ATHNdatasest does not adequately capture data specific to WG with bleeding disorders. Further, the investigators hypothesize that it is feasible for Hemophilia Treatment Centers (HTCs) to include data points specific to WG with bleeding disorder when enrolling participants in the ATHNdataset. This hypothesis will be evaluated through the following specific aims:
Specific Aim 1: Characterize reproductive tract bleeding in a cohort of WG with bleeding disorders cared for at US HTCs.
Specific Aim 2: Characterize the treatment strategies for and the impact of heavy menstrual bleeding in a cohort of females with bleeding disorders cared for at HTCs.
Specific Aim 3: Evaluate the feasibility of adding female specific core data points to the ATHNdataset.
|Condition or disease|
|Hemophilia A Bleeding Disorder|
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||300 participants|
|Target Follow-Up Duration:||1 Day|
|Official Title:||Characterizing the Impact and Treatment of Reproductive Tract Bleeding on Women and Post-menarchal Girls With Bleeding Disorders.|
|Actual Study Start Date :||September 5, 2018|
|Estimated Primary Completion Date :||September 4, 2019|
|Estimated Study Completion Date :||September 4, 2019|
- Reproductive tract bleeding will be characterized utilizing the ISTH-BAT(International Society of Thrombosis and Haemostasis Bleeding Assessment Tool) [ Time Frame: 1 year ]The ISTH-BAT is the International Society on Thrombosis and Hemostasis Bleeding Assessment Tool and can be self-administered. It provides an overall bleeding score as well as information about specific bleeding symptoms.
- Reproductive tract bleeding will be characterized utilizing the Menstrual Bleeding Questionnaire. [ Time Frame: 1 year ]The Menstrual Bleeding Questionnaire is a patient reported outcome tool specific to the symptom of menstrual bleeding. It is also self-administered.
- Reproductive tract bleeding will be characterized by reviewing the medical history [ Time Frame: 1 year ]Utilizing the current ATHNdataset data forms, the medical history will be reviewed and symptoms and diagnoses specific to menstrual bleeding will be entered.
- Identify treatment strategies for heavy menstrual bleeding through patient report [ Time Frame: 1 year ]Utilizing a form previously developed, participants will indicate previous treatments utilized for heavy menstrual bleeding and rank their effectiveness.
- Evaluate impact through quality of life tool (PROMIS-29) [ Time Frame: 1 year ]Participants will complete the PROMIS-29 quality of life tool.
- Evaluate impact through quality of life tool (EQ-5D) [ Time Frame: 1 year ]Participants will complete the EQ-5D quality of life tool.
- Evaluate the feasibility of entering female specific core data points to the ATHNdataset. [ Time Frame: 1 year ]Study site coordinators will complete a feasibility questionnaire regarding the challenges of adding female specific data to the ATHNdataset.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03834727
|United States, Oregon|
|Oregon Health and Science University|
|Portland, Oregon, United States, 97239|
|Principal Investigator:||Kristina Haley, DO||Oregon Health and Science University|