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

NCT03834727 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 256

Last updated 2023-04-18

No results posted yet for this study

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

Sponsors & Collaborators

  • American Thrombosis and Hemostasis Network

    collaborator NETWORK

  • Oregon Health and Science University

    lead OTHER

Principal Investigators

  • Kristina Haley, DO · Oregon Health and Science University

Eligibility

Min Age
10 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-05
Primary Completion
2022-04-01
Completion
2022-04-01

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03834727 on ClinicalTrials.gov