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NCT02685501 Clinical Trial

Menorrhagia, Dysmenorrhea and Iron Deficiency Among Young Women Soldiers and Effect on Activity

Iron Deficiency Anemia Clinical Trial

Official title:
Menorrhagia, Dysmenorrhea and Iron Deficiency Among Young Women Soldiers

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02685501
Other study ID # Menorrhagia-HMO-CTIL
Secondary ID
Status Recruiting
Phase N/A
First received February 14, 2016
Last updated February 23, 2016
Start date January 2016
Est. completion date June 2017

Study information
Verified date February 2016
Source Hadassah Medical Organization
Contact n/a
Is FDA regulated No
Health authority Israel: Army Medical Ethics Comitte
Study type Observational

Clinical Trial Summary

As combat women soldiers are required to more intensive daily activity the investigators believe that the impact of menorrhagia, dysmenorrhea and its clinical consequence (as characterized by, anemia iron deficiency and reduced quality of life)) on personal performance will be more significant in combat women soldiers compared to non-combat women soldiers. Using cohorts from the same environment will enable the investigators to better study the effect of menorrhagia and dysmenorrhea eliminating other uncontrolled factors, such as nutrition. The study does not include any intervention.

Recruitment information / eligibility
Status Recruiting
Enrollment 800
Est. completion date June 2017
Est. primary completion date December 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 25 Years
Eligibility Inclusion Criteria:

- Women soldiers in the participating units

Exclusion Criteria:

- Lack of consent

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Other:
• no intervention

Locations
Country Name City State
Israel Hadassah Medical Organization Jerusalem
Israel Hadassah Medical Organization Jerusalem

Sponsors (1)
Lead Sponsor Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary Menorrhagia and dysmenorrhea The prevalence of menorrhagia and dysmenorrhea and association with quality of life will be assessed one year No
Secondary Iron deficiency The prevalence of iron deficiency and iron deficiency anemia will be assessed by laboratory tests. one year No
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