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

NCT03834727 | Completed

• 1 other identifier: 00018857
• Study Type: observational
• Target: 256
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hemophilia A; Bleeding Disorder

Outcome Measures

Primary Outcomes (7)

• Reproductive tract bleeding will be characterized utilizing the ISTH-BAT(International Society of Thrombosis and Haemostasis Bleeding Assessment Tool)

  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.

  1 year

• Reproductive tract bleeding will be characterized utilizing the Menstrual Bleeding Questionnaire.

  The Menstrual Bleeding Questionnaire is a patient reported outcome tool specific to the symptom of menstrual bleeding. It is also self-administered.

  1 year

• Reproductive tract bleeding will be characterized by reviewing the medical history

  Utilizing the current ATHNdataset data forms, the medical history will be reviewed and symptoms and diagnoses specific to menstrual bleeding will be entered.

  1 year

• Identify treatment strategies for heavy menstrual bleeding through patient report

  Utilizing a form previously developed, participants will indicate previous treatments utilized for heavy menstrual bleeding and rank their effectiveness.

  1 year

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

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

  1 year

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

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

  1 year

• Evaluate the feasibility of entering female specific core data points to the ATHNdataset.

  Study site coordinators will complete a feasibility questionnaire regarding the challenges of adding female specific data to the ATHNdataset.

  1 year

Eligibility Criteria

• Age: 10 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women and girls receiving care at federally funded US Hemophilia Treatment Centers will be approached regarding participation.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Oregon Health and Science University: lead
• American Thrombosis and Hemostasis Network: collaborator

Study Sites (1)

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Hemophilia A; Hemostatic Disorders

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, Inherited; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Kristina Haley, DO

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 18, 2018
• First Posted: February 8, 2019
• Study Start: September 5, 2018
• Primary Completion: April 1, 2022
• Study Completion: April 1, 2022
• Last Updated: April 18, 2023

Record last verified: 2023-04

Locations

US (1)