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

• Sponsor: Hadassah Medical Organization (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02685501
• Collaborator: (none)
• Enrollment: 800
• Locations: 2
• Duration (Months): 17
• Patients Per Site: 400
• Patients Per Site Per Month: 23.5

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Menorrhagia; Dysmenorrhea; Iron Deficiency Anemia	Other: no intervention

Study Design

• Study Type: Observational
• Anticipated Enrollment: 800 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Menorrhagia, Dysmenorrhea and Iron Deficiency Among Young Women Soldiers
• Study Start Date: Jan 1, 2016
• Anticipated Primary Completion Date: Dec 1, 2016
• Anticipated Study Completion Date: Jun 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Combat women soldiers Women soldiers in combat units	Other: no intervention
Non combat women soldiers Women soldiers in non-combat units	Other: no intervention

Outcome Measures

Primary Outcome Measures

1. Menorrhagia and dysmenorrhea [one year]

   The prevalence of menorrhagia and dysmenorrhea and association with quality of life will be assessed

Secondary Outcome Measures

1. Iron deficiency [one year]

   The prevalence of iron deficiency and iron deficiency anemia will be assessed by laboratory tests.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 25 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Women soldiers in the participating units

Exclusion Criteria:

• Lack of consent

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hadassah Medical Organization	Jerusalem		Israel	91120
2	Hadassah Medical Organization	Jerusalem		Israel

Sponsors and Collaborators

• Hadassah Medical Organization

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Shoshana Vilk, Prof. Shoshana Revel-Villk, Hadassah Medical Organization
• ClinicalTrials.gov Identifier: NCT02685501
• Other Study ID Numbers: Menorrhagia-HMO-CTIL
• First Posted: Feb 18, 2016
• Last Update Posted: Feb 24, 2016
• Last Verified: Feb 1, 2016

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Additional relevant MeSH terms: Menorrhagia; Anemia, Iron-Deficiency; Dysmenorrhea

Study Results

No Results Posted as of Feb 24, 2016