NCT05079815

Brief Summary

In the present study, we test the ability of AMSS as a simple tool to identify women with HMB who have ID/ IDA. We will compare the AMSS score to patients' hemoglobin and serum ferritin in women with self-reported HMB and women with normal menstrual flow.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2024

Shorter than P25 for all trials

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 3, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

October 15, 2021

Completed
2.5 years until next milestone

Study Start

First participant enrolled

May 1, 2024

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2025

Completed
Last Updated

February 8, 2023

Status Verified

February 1, 2023

Enrollment Period

Same day

First QC Date

October 3, 2021

Last Update Submit

February 4, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Evaluating the Arabic version of Aberdeen Menorrhagia Severity Scale (AMSS) for prediction of iron deficiency/ iron deficiency anemia in women with the symptom of chronic heavy menstrual bleeding (HMB)

    heavy menstrual bleeding and its relation to iron deficiency /iron deficiency anemia

    baseline

Interventions

CBC and serum ferritinDIAGNOSTIC_TEST

take blood sample for CBC and serum ferritin

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsgynaecological research about heavy menstrual bleeding
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Details on the research will be explained to potentially eligible women. They will be given patient's information leaflet in Arabic (attached). The research team will emphasize that participation in the study is completely voluntary, and women can withdraw at any time without affecting level of care that is provided for them. Eligible women who accept to participate in the study will sign informed consent. Women will be assured on confidentiality and that data will be coded, with no names/ identifying information, and will be kept on a secure server through RedCap operated by Assiut Faculty of Medicine.3.4. Informed consent. Consent will be provided

You may qualify if:

  • Reproductive age women, above age of 18 years old.

You may not qualify if:

  • women with amenorrhea, postmenopausal women, current or past (in last 6 months) users of hormonal contraceptives, women who have delivered in the past year, or breast fed in past 6 months are all excluded from the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Cooke AG, McCavit TL, Buchanan GR, Powers JM. Iron Deficiency Anemia in Adolescents Who Present with Heavy Menstrual Bleeding. J Pediatr Adolesc Gynecol. 2017 Apr;30(2):247-250. doi: 10.1016/j.jpag.2016.10.010. Epub 2016 Oct 24.

    PMID: 27789349BACKGROUND
  • Peuranpaa P, Heliovaara-Peippo S, Fraser I, Paavonen J, Hurskainen R. Effects of anemia and iron deficiency on quality of life in women with heavy menstrual bleeding. Acta Obstet Gynecol Scand. 2014 Jul;93(7):654-60. doi: 10.1111/aogs.12394. Epub 2014 Jun 9.

    PMID: 24912842BACKGROUND

MeSH Terms

Conditions

Menorrhagia

Interventions

Blood Cell Count

Condition Hierarchy (Ancestors)

Uterine HemorrhageUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsMenstruation Disturbances

Intervention Hierarchy (Ancestors)

Cell CountCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisHematologic TestsInvestigative TechniquesCell Physiological PhenomenaBlood Physiological PhenomenaCirculatory and Respiratory Physiological Phenomena

Central Study Contacts

Ebraam faiez, bachelor

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
doctor

Study Record Dates

First Submitted

October 3, 2021

First Posted

October 15, 2021

Study Start

May 1, 2024

Primary Completion

May 1, 2024

Study Completion

May 1, 2025

Last Updated

February 8, 2023

Record last verified: 2023-02