NCT02685501

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
800

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2016

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 14, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 18, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

February 24, 2016

Status Verified

February 1, 2016

Enrollment Period

11 months

First QC Date

February 14, 2016

Last Update Submit

February 23, 2016

Conditions

MenorrhagiaDysmenorrheaIron Deficiency Anemia

Outcome Measures

Primary Outcomes (1)

  • Menorrhagia and dysmenorrhea

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

    one year

Secondary Outcomes (1)

  • Iron deficiency

    one year

Study Arms (2)

Combat women soldiers

Women soldiers in combat units

Other: no intervention

Non combat women soldiers

Women soldiers in non-combat units

Other: no intervention

Interventions

no interventionOTHER
Combat women soldiersNon combat women soldiers

Eligibility Criteria

Age18 Years - 25 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Women soldiers

You may qualify if:

  • Women soldiers in the participating units

You may not qualify if:

  • Lack of consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hadassah Medical Organization

Jerusalem, 91120, Israel

RECRUITING

Hadassah Medical Organization

Jerusalem, Israel

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

CBC, ferritin

MeSH Terms

Conditions

MenorrhagiaDysmenorrheaAnemia, Iron-Deficiency

Condition Hierarchy (Ancestors)

Uterine HemorrhageUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsMenstruation DisturbancesPelvic PainPainNeurologic ManifestationsSigns and SymptomsAnemia, HypochromicAnemiaHematologic DiseasesHemic and Lymphatic DiseasesIron DeficienciesIron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Shoshana Revel-Villk

Study Record Dates

First Submitted

February 14, 2016

First Posted

February 18, 2016

Study Start

January 1, 2016

Primary Completion

December 1, 2016

Study Completion

June 1, 2017

Last Updated

February 24, 2016

Record last verified: 2016-02

Locations

IL(2)