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NCT Number: NCT03834727

Characterizing the Impact and Treatment of Reproductive Tract Bleeding on Women and Post-menarchal Girls With Bleeding Disorders

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.

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Key information

Conditions

Hemophilia A Bleeding Disorder Blood Coagulation Disorders Blood Coagulation Disorders, Inherited Cardiovascular Diseases Coagulation Protein Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Vascular Diseases

Age range

10 year–65 year

Sex eligibility

Female

Study type

Observational

Primary location

Oregon Health and Science University

Portland, Oregon, 97239, United States

About this study

This is a multi-center, cross-sectional study of women and girls with bleeding disorders receiving care at Hemophilia Treatment Centers (HTCs). To further characterize this population, WG who receive care at federally funded US HTCs will be approached regarding participation. Following assent and/or consent, participants will be asked to complete a series of forms. In order to assess their bleeding symptoms, they will complete the self-BAT (Bleeding Assessment Tool) as well as the Menstrual Bleeding Questionnaire (MBQ). In order to assess their quality of life, they will complete the PROMIS-29 quality of life inventories. Patients may be contacted if they miss a question on any of these forms. Phone call should take no more than 15 minutes. Study staff will complete an intake form which includes data regarding bleeding disorder diagnosis as well as treatment, using information obtained from the patient, chart review, and the ATHNdataset.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women and girls with an active diagnosis of a congenital bleeding disorder (as designated by the institution inputting data);
  • Deficiencies of factors VIII, IX, II, V, VII, VII, IX, X, XI, FV+VIII, XIII, Plasminogen Activator Inhibitor 1(PAI-1), hypo-, a-, or dys-fibrinogenemia
  • von Willebrand Disease (Type 1, Type 1c, Type 2A, Type 2B, Type 2M, Type 2N, Type 3, Low VWF)
  • Any platelet function disorder (i.e. Glanzmann Thrombasthenia, Bernard Soulier Syndrome, Platelet Storage Pool disorder, MYH9 disorders, Gray Platelet syndrome, Dense granule deficiency)
  • Ehlers Danlos Syndrome
  • Post-menarchal: has had at least 1 period at the time of study entry
  • Participating in the ATHNdataset

Exclusion criteria

  • Male gender
  • Acquired bleeding disorder
  • Thrombotic disorder
  • Non-English speaking

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. Evaluate impact through quality of life tool (PROMIS-29)

    Time frame: 1 year

    Participants will complete the PROMIS-29 quality of life tool.

  6. Evaluate impact through quality of life tool (EQ-5D)

    Time frame: 1 year

    Participants will complete the EQ-5D quality of life tool.

  7. 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.

Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Collaborators

  • American Thrombosis and Hemostasis Network

Registry information

Official study title

Characterizing the Impact and Treatment of Reproductive Tract Bleeding on Women and Post-menarchal Girls With Bleeding Disorders.

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Feb 8, 2019
Registry last updated
Apr 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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