MedTrace Logo

Evaluation of Menses in Congenital Bleeding Disorders

NCT01261936 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2010-12-17

No results posted yet for this study

Summary

Menorrhagia is the term used to define excessive menstrual blood losses, as often based on a subjective judgment of women. Many arbitrary values, expressed in milliliters of blood, have been proposed to define this symptom: 60 on each cycle has also been confirmed in our preliminary study on 87 healthy women. The quantitative determination of menstrual blood losses is nevertheless rarely performed, only in research settings. Although menorrhagia is a quite frequent symptom in healthy women apparently haemostatically competent in the fertile age (20-30%), its incidence becomes very high in women affected by congenital coagulation factors deficiency and (50-62.9%) inherited platelet defects, e.g. Glanzmann's Thromboasthenia (GT); also in von Willebrand Disease the bleeding symptom "menorrhagia" has an high prevalence (60-75%)(8); for GT an incidence of 90% has been reported.

This explains the need for a study focused on the evaluation of menorrhagia in CBDs, addressed to answer to the following, still unsolved questions:

1. Definition of the entity of menstrual blood losses in women affected by CBDs
2. Elaboration of specific treatment schedules for each type of CBD
3. Impact of different specific treatment schedules on kinetic and entity of menstrual losses (how does treatment modify losses?).

Conditions

  • Von Willebrand Disease
  • Congenital Coagulation Factors Deficiency
  • Haemophilia Carriers

Sponsors & Collaborators

  • University of L'Aquila

    lead OTHER

Principal Investigators

  • guglielmo mariani, md · ospedale "san salvatore"

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-02-28
Completion
2011-12-31

Countries

  • Italy

Study Locations

More Related Trials

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 NCT01261936 on ClinicalTrials.gov