NCT06201767

Brief Summary

Evaluation of Abnormal Uterine Bleeding in Adolescents: A Cross Sectional Observational Study

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
323

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2024

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

Study Start

First participant enrolled

January 1, 2024

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

January 2, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 11, 2024

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2025

Completed
Last Updated

January 11, 2024

Status Verified

January 1, 2024

Enrollment Period

1.1 years

First QC Date

January 2, 2024

Last Update Submit

January 2, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Evaluation of abnormal uterine bleeding and determining the type of abnormality.

    baseline

Secondary Outcomes (1)

  • Analysing various cause of AUB in this age according to FIGO classification system. Analysing various cause of AUB in this age according to FIGO classification system

    baseline

Eligibility Criteria

Age10 Years - 19 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

Detailed History tacking including: * Personal history age, residence, marital status, special habits, menstrual history * Present history * Obstetric history for married adolescents for gravity, parity, pregnancy complication * Past history and gynecological conditions as myomectomy, ovarian cystectomy * Family history for bleeding tendency as von willebrand disease or coagulopathies * Examination: * Investigations Laboratory like complete blood picture, coagulation profile, hormonal analysis (TSH, prolactin, LH, FSH), assessment von wollbrand disease by von wollbrand factor antigen and activity Ultrasonography for evaluation

You may qualify if:

  • \- Adolescent female 10- 19 years old
  • Any abnormal uterine bleeding

You may not qualify if:

  • Adolescent female with normal uterine bleeding
  • Primary amenorrhea

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Betha, K., Malavatu, L. & Talasani, S. 2017. Distribution of causes of abnormal uterine bleeding using new FIGO classification system-PALM COEIN: a rural tertiary hospital based study. International Journal of Reproduction, Contraception, Obstetrics and Gynecology, 6, 3523-3528. Bisht, D. S. & Kalra, R. 2023. Endometrial Biopsy Audit and its Clinico-Pathological Correlation in Patients with Abnormal Uterine Bleeding in a Zonal Care Centre. International Journal of Contemporary Pathology, 9. Heremans, R., Van Den Bosch, T., Valentin, L., et al. 2022. Ultrasound features of endometrial pathology in women without abnormal uterine bleeding: results from the International Endometrial Tumor Analysis study (IETA3). Ultrasound in Obstetrics & Gynecology, 60, 243-255. Marnach, M. L. & Laughlin-Tommaso, S. K. Evaluation and management of abnormal uterine bleeding. Mayo Clinic Proceedings, 2019. Elsevier, 326-335. Munro, M. G., Critchley, H. O., Fraser, I. S., et al. 2018. The two FIGO systems for normal and abnormal uterine bleeding symptoms and classification of causes of abnormal uterine bleeding in the reproductive years: 2018 revisions. International Journal of Gynecology & Obstetrics, 143, 393-408. Sabre, A., Serventi, L., Nuritdinova, D., et al. 2021. Abnormal uterine bleeding types according to the PALM-COEIN FIGO classification in a medically underserved American community. Journal of the Turkish German Gynecological Association, 22, 91. Sarala, V. & Gopalan, U. 2020. Clinical pattern and presentation of abnormal uterine bleeding. International Journal of Reproduction, Contraception, Obstetrics and Gynecology, 9, 126-129. Singh, N., Faruqi, M. & Pradeep, Y. 2019. Clinico epidemiological profile of abnormal uterine bleeding in reproductive womens: a cross sectional study. International Journal of Reproduction, Contraception, Obstetrics and Gynecology, 8, 4396. Singh, P. B., Purwar, R. & Mall, R. P. 2021. Clinical spectrum and causes of abnormal uterine bleeding in reproductive age according to two FIGO systems. The New Indian Journal of OBGYN, 8, 105-106. Tsakiridis, I., Giouleka, S., Koutsouki, G., et al. 2022. Investigation and management of abnormal uterine bleeding in reproductive-aged women: a descriptive review of national and international recommendations. The European Journal of Contraception & Reproductive Health Care, 27, 504-517. Tuchkina, I. O., Vygivska, L. A. & Novikova, A. A. 2020. Abnormal uterine bleeding in adolescents: current state of the problem. Wiadomości Lekarskie, 73, 1752-1755. Van Den Bosch, T., Verbakel, J., Valentin, L., et al. 2021. Typical ultrasound features of various endometrial pathologies described using International Endometrial Tumor Analysis (IETA) terminology in women with abnormal uterine bleeding. Ultrasound in Obstetrics & Gynecology, 57, 164-172.

    BACKGROUND

MeSH Terms

Conditions

Metrorrhagia

Condition Hierarchy (Ancestors)

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

Study Officials

  • Ahmed Ali Mohamed, professor

    Al-Azhar University

    STUDY DIRECTOR

Central Study Contacts

Wafaa kassem Badr, resident

CONTACT

Abd Elhalim Mohammed Abd Elhalim

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Evaluation of Abnormal Uterine Bleeding in Adolescents: A Cross Sectional Observational Study

Study Record Dates

First Submitted

January 2, 2024

First Posted

January 11, 2024

Study Start

January 1, 2024

Primary Completion

February 1, 2025

Study Completion

April 1, 2025

Last Updated

January 11, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will share