MenorrhagiaMenorrhagiaNCT06660459
Pattern of Menorrhagic Female Attending the Hematology Unit in Assuit University Children Hospital
An observational study of Menorrhagia, run by Assiut University.
Trial summary
To Evaluate Causes of Menorrhagia in Adolescent FemalesSpecially Hematological causes to help in management of abnormal uterine bleeding. Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Menorrhagia
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 20 Oct 2024to 20 Nov 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Female from age 8 years to age 18 years diseased with menorrhagia and help In dignosis and prevent utrine bleeding
Who may be able to join
- 1. Age of female patients range from (9 -18) years old.
- 2. Girls with heavy menstrual bleeding
Who cannot join
- 1. Patients on medication affecting coagulation profile. 2. Patients with pre-existing illness as chronic lung, liver, renal disease or malignancy.
Trial locations and contacts
No sites are listed yet.
About this study
To Evaluate Causes of Menorrhagia in Adolescent FemalesSpecially Hematological causes to help in management of abnormal uterine bleeding.
Read the detailed description
Abnormal uterine bleeding (AUB) is defined as bleeding from uterine corpus that is abnormal in duration, volume, frequency and/or regularity. Due to immaturity of the hypothalamic-pituitary-ovarian (HPO) axis, AUB is common in adolescents. [1] Furthermore, inherited or acquired bleeding disorder may further intensify the existing hormonal imbalance and increase morbidity of the underlying condition.
In addition to these problems, hyperprolactinemia, thyroid disorders and polycystic ovary syndrome (PCOS) are the common underlying endocrine disorders. [2] Abnormal Uterine Bleeding decreases quality of life, affects school attendance and limits sports and social activity participation. [3] The normal menstrual cycle depends on the feedback loops of estrogen and progesterone on the production of luteinizing hormone and follicle-stimulating hormone by the pituitary gland and on the hypothalamus's normal function as metronome for the hypothalamic-pituitary- ovarian axis. [4] Differential diagnosis of abnormal uterine bleeding in adolescents: Bleeding disorders: (Von Willebrand disease, Platelet dysfunction Thrombocytopenia, Clotting factor deficiency) Endocrine causes: (Anovulatory bleeding, Polycystic ovary syndrome, Thyroid disorders, Hyperprolactinemia ).
Gynacological causes: (Adenomyosis, leiomyoma,polyp, malignancy, ovulatory dysfunction)(5) Medications: (Anticoagulants, Depot medroxyprogesterone, implants Intrauterine devices). [7] A woman's monthly menstruation takes a large toll on the hemostatic system. To avoid excessive bleeding. Any quantitative or qualitative disruption of the hemostatic
system can lead to increased menstrual bleeding. Primary hemostasis: involves the integration of platelets and von Willebrand factor (VWF). Initiation of primary hemostasis begins with injury to the blood vessel wall.
This injury allows exposure of collagen, elastin, and VWF causes platelets to activate and bind to VWF. Platelets are activated to signal further platelet activation and aggregation , which leads to the formation of the primary hemostatic plug. [8] Secondary hemostasis involves coagulation proteins called factors, the blood vessel wall, and fibrin. Endothelial wall injury causes the release of tissue factor ,which activates factor(F)VII to the activated form, FVIIa.15 The tissue factor/FVIIa complex activates the remainder of the coagulation cascade and the formation of thrombin. The final step is the activation of FXIII ,which cross links fibrin chains to form the fibrin clot. Anticoagulants, such as protein C,S , and antithrombin, as well as plasmin, help balance this procoagulant state and prevent excessive thrombus formation. [9] Most adolescents need outpatient management and reassurance that their menstrual cycles would become cyclic and ovulatory over time. However, treatment is required when AUB causes anemia or impairs quality of life . In these girls, the first line treatment is generally medical. Acute AUB patients who are clinically unstable, have active bleeding or severe anemia should be hospitalized for management A clinical decision should be made regarding intravenous crystalloid and blood or blood product transfusions, hormone treatment, and iron replacement, according to the severity of bleeding, clinical condition of the patient, hemodynamic stability and the underlying medical problem. If an underlying cause can be identified, appropriate specific treatment should be given
- Conditions
- Menorrhagia
- Keywords
- Menorrhagia
- Medical subject headings
- Menorrhagia
What is being measured
The primary outcome is the main question the study is designed to answer.
Evalution Causes of Menorrhagia in Adolescent FemalesSpecially Hematological causes to help in management
Evalution Causes of Menorrhagia in Adolescent Females Specially Hematological causes to help in management
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2024
- Study start20 Oct 2024 (estimated)
- Primary completion20 Oct 2025 (estimated)
- Study completion20 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for MenorrhagiaStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hasnaa Fawzy Abdelbasir Ibrahim, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06660459
- Sponsor's protocol ID
- Menorrhagic female
- Acronym
- Menorrhagia
- Status last verified
- Oct 2024
- First submitted
- 24 Oct 2024
- Last updated
- 28 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
ACOG Committee Opinion No. 651: Menstruation in Girls and Adolescents: Using the Menstrual Cycle as a Vital Sign. Obstet Gynecol. 2015 Dec;126(6):e143-e146. doi: 10.1097/AOG.0000000000001215.
PubMed 26595586Barbieri RL. The endocrinology of the menstrual cycle. Methods Mol Biol. 2014;1154:145-69. doi: 10.1007/978-1-4939-0659-8_7.
PubMed 24782009
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pattern of Menorrhagic Female Attending the Hematology Unit in Assuit University Children Hospital
- ClinicalTrials.gov ID
- NCT06660459
- Acronym / sponsor ID
- Menorrhagia / Menorrhagic female
- Conditions
- Menorrhagia
- Keywords
- Menorrhagia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 20 Oct 2024 (estimated)
- Primary completion
- 20 Oct 2025 (estimated)
- Study completion
- 20 Nov 2025 (estimated)
- First posted
- 28 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To Evaluate Causes of Menorrhagia in Adolescent FemalesSpecially Hematological causes to help in management of abnormal uterine bleeding.
Detailed description
Abnormal uterine bleeding (AUB) is defined as bleeding from uterine corpus that is abnormal in duration, volume, frequency and/or regularity. Due to immaturity of the hypothalamic-pituitary-ovarian (HPO) axis, AUB is common in adolescents. [1] Furthermore, inherited or acquired bleeding disorder may further intensify the existing hormonal imbalance and increase morbidity of the underlying condition.
In addition to these problems, hyperprolactinemia, thyroid disorders and polycystic ovary syndrome (PCOS) are the common underlying endocrine disorders. [2] Abnormal Uterine Bleeding decreases quality of life, affects school attendance and limits sports and social activity participation. [3] The normal menstrual cycle depends on the feedback loops of estrogen and progesterone on the production of luteinizing hormone and follicle-stimulating hormone by the pituitary gland and on the hypothalamus's normal function as metronome for the hypothalamic-pituitary- ovarian axis. [4] Differential diagnosis of abnormal uterine bleeding in adolescents: Bleeding disorders: (Von Willebrand disease, Platelet dysfunction Thrombocytopenia, Clotting factor deficiency) Endocrine causes: (Anovulatory bleeding, Polycystic ovary syndrome, Thyroid disorders, Hyperprolactinemia ).
Gynacological causes: (Adenomyosis, leiomyoma,polyp, malignancy, ovulatory dysfunction)(5) Medications: (Anticoagulants, Depot medroxyprogesterone, implants Intrauterine devices). [7] A woman's monthly menstruation takes a large toll on the hemostatic system. To avoid excessive bleeding. Any quantitative or qualitative disruption of the hemostatic
system can lead to increased menstrual bleeding. Primary hemostasis: involves the integration of platelets and von Willebrand factor (VWF). Initiation of primary hemostasis begins with injury to the blood vessel wall.
This injury allows exposure of collagen, elastin, and VWF causes platelets to activate and bind to VWF. Platelets are activated to signal further platelet activation and aggregation , which leads to the formation of the primary hemostatic plug. [8] Secondary hemostasis involves coagulation proteins called factors, the blood vessel wall, and fibrin. Endothelial wall injury causes the release of tissue factor ,which activates factor(F)VII to the activated form, FVIIa.15 The tissue factor/FVIIa complex activates the remainder of the coagulation cascade and the formation of thrombin. The final step is the activation of FXIII ,which cross links fibrin chains to form the fibrin clot. Anticoagulants, such as protein C,S , and antithrombin, as well as plasmin, help balance this procoagulant state and prevent excessive thrombus formation. [9] Most adolescents need outpatient management and reassurance that their menstrual cycles would become cyclic and ovulatory over time. However, treatment is required when AUB causes anemia or impairs quality of life . In these girls, the first line treatment is generally medical. Acute AUB patients who are clinically unstable, have active bleeding or severe anemia should be hospitalized for management A clinical decision should be made regarding intravenous crystalloid and blood or blood product transfusions, hormone treatment, and iron replacement, according to the severity of bleeding, clinical condition of the patient, hemodynamic stability and the underlying medical problem. If an underlying cause can be identified, appropriate specific treatment should be given
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Female from age 8 years to age 18 years diseased with menorrhagia and help In dignosis and prevent utrine bleeding
Key inclusion criteria (2 listed)
- 1. Age of female patients range from (9 -18) years old.
- 2. Girls with heavy menstrual bleeding
Key exclusion criteria (1 listed)
- 1. Patients on medication affecting coagulation profile. 2. Patients with pre-existing illness as chronic lung, liver, renal disease or malignancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evalution Causes of Menorrhagia in Adolescent FemalesSpecially Hematological causes to help in management
Time frame: Baseline
Evalution Causes of Menorrhagia in Adolescent Females Specially Hematological causes to help in management
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2024.
- Results publication: PubMed 26595586ACOG Committee Opinion No. 651: Menstruation in Girls and Adolescents: Using the Menstrual Cycle as a Vital Sign. Obstet Gynecol. 2015 Dec;126(6):e143-e146. doi: 10.1097/AOG.0000000000001215.
- Results publication: PubMed 24782009Barbieri RL. The endocrinology of the menstrual cycle. Methods Mol Biol. 2014;1154:145-69. doi: 10.1007/978-1-4939-0659-8_7.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Menorrhagia, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hasnaa Fawzy Abdelbasir Ibrahim., Doctor (00201151682882, Hasnaafawzy34@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evalution Causes of Menorrhagia in Adolescent FemalesSpecially Hematological causes to help in management (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06660459, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2024.