Ignite Creation Date:
2025-12-25 @ 12:45 AM
Ignite Modification Date:
2025-12-26 @ 1:36 PM
Study NCT ID:
NCT06201767
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-01-11
First Post:
2024-01-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Abnormal Uterine Bleeding in Adolescents: A Cross Sectional Observational Study
Sponsor:
Al-Azhar University
Organization:
Study Overview
Official Title:
Evaluation of Abnormal Uterine Bleeding in Adolescents: A Cross Sectional Observational Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Evaluation of Abnormal Uterine Bleeding in Adolescents: A Cross Sectional Observational Study
Detailed Description:
Abnormal uterine bleeding (AUB) is defined as any type of bleeding in which the amount, duration, frequency and cyclicity is abnormal for a patient. It is very common symptom and it is seen in 15-20% of patient from the commencement of menarche to menopause (Singh et al., 2021). Over all prevalence of AUB varies in different population fluctuating between 10% and 30% (Sarala and Gopalan, 2020).
Although AUB may be characterized by specific menstrual abnormalities including dysmenorrhea, menorrhagia, oligomenorrhea, etc., the cause of AUB is often unknown. According to International Federation of Obstetrics and Gynecology (FIGO) the classification of AUB is based on PALMCOEIN which is an acronym for various etiologies namely polyp, adenomyosis, leiomyoma, malignancy and hyperplasia, coagulopathy, ovulatory dysfunction, endometrial disorders, iatrogenic and not otherwise classified (PALM-COEIN) (Betha et al., 2017, Sabre et al., 2021).
At the pathological level, AUB is predominantly characterized by anovulatory cycles. When ovulation does not occur, no corpus luteum is formed to produce progesterone, leading to prolonged estrogenic stimulation of the endometrium and irregular bleeding. The patient will present with polymennorrhagia, polymenorrhea and metrorrhagia (Tuchkina et al., 2020).
The non-shedding of endometrium causes an increased risk of endometrial cancer. As a clinical approach to AUB, it is essential to obtain history pertaining to puberty and menstrual history in terms of regularity, volume and duration of cycles. In addition, reproductive and sexual history plays a major role in determining the etiology of AUB in married women (Tsakiridis et al., 2022).
It is also essential to consider various non-reproductive causes of AUB, namely nutritional history, endocrine disorders, socioeconomic status and current medication history. Clinical evaluation in terms of abdominal and per vaginal examination aids in the diagnosis. But conclusive results are obtained only when the endometrium is examined either by ultrasound or histological sampling (Sabre et al., 2021, Bisht and Kalra, 2023).
Diagnosis of AUB depends upon comprehensive medical history, blood tests, imaging and histopathology. Bleeding pattern style forms the clinical basis for diagnosis of different types of AUB. Some standard menstrual index parameters are used to define bleeding pattern which are frequency, duration, regularity, volume and intermenstrual bleeding (Munro et al., 2018, Singh et al., 2019).
In majority of the patients, AUB is a recurring problem and therefore, poses a challenge to the care providers in terms of clinical management. Moreover, its consequences are increasingly incriminating on the quality of life of these reproductive women, due to the impact on general health and wellbeing (Sarala and Gopalan, 2020).
Although studies have been done on evaluating the endometrium for various pathologies, there is still a vacuum with regards to the clinical presentation and correlation of AUB (Marnach and Laughlin-Tommaso, 2019, Van Den Bosch et al., 2021, Heremans et al., 2022). Clinical correlation plays a significant role in limited resource settings, especially in developing economies like Egypt, and an in-depth evaluation of clinical presentation of AUB will aid the primary care physician to detect AUB at an early stage and appropriate referral for advanced care.
Although AUB may be characterized by specific menstrual abnormalities including dysmenorrhea, menorrhagia, oligomenorrhea, etc., the cause of AUB is often unknown. According to International Federation of Obstetrics and Gynecology (FIGO) the classification of AUB is based on PALMCOEIN which is an acronym for various etiologies namely polyp, adenomyosis, leiomyoma, malignancy and hyperplasia, coagulopathy, ovulatory dysfunction, endometrial disorders, iatrogenic and not otherwise classified (PALM-COEIN) (Betha et al., 2017, Sabre et al., 2021).
At the pathological level, AUB is predominantly characterized by anovulatory cycles. When ovulation does not occur, no corpus luteum is formed to produce progesterone, leading to prolonged estrogenic stimulation of the endometrium and irregular bleeding. The patient will present with polymennorrhagia, polymenorrhea and metrorrhagia (Tuchkina et al., 2020).
The non-shedding of endometrium causes an increased risk of endometrial cancer. As a clinical approach to AUB, it is essential to obtain history pertaining to puberty and menstrual history in terms of regularity, volume and duration of cycles. In addition, reproductive and sexual history plays a major role in determining the etiology of AUB in married women (Tsakiridis et al., 2022).
It is also essential to consider various non-reproductive causes of AUB, namely nutritional history, endocrine disorders, socioeconomic status and current medication history. Clinical evaluation in terms of abdominal and per vaginal examination aids in the diagnosis. But conclusive results are obtained only when the endometrium is examined either by ultrasound or histological sampling (Sabre et al., 2021, Bisht and Kalra, 2023).
Diagnosis of AUB depends upon comprehensive medical history, blood tests, imaging and histopathology. Bleeding pattern style forms the clinical basis for diagnosis of different types of AUB. Some standard menstrual index parameters are used to define bleeding pattern which are frequency, duration, regularity, volume and intermenstrual bleeding (Munro et al., 2018, Singh et al., 2019).
In majority of the patients, AUB is a recurring problem and therefore, poses a challenge to the care providers in terms of clinical management. Moreover, its consequences are increasingly incriminating on the quality of life of these reproductive women, due to the impact on general health and wellbeing (Sarala and Gopalan, 2020).
Although studies have been done on evaluating the endometrium for various pathologies, there is still a vacuum with regards to the clinical presentation and correlation of AUB (Marnach and Laughlin-Tommaso, 2019, Van Den Bosch et al., 2021, Heremans et al., 2022). Clinical correlation plays a significant role in limited resource settings, especially in developing economies like Egypt, and an in-depth evaluation of clinical presentation of AUB will aid the primary care physician to detect AUB at an early stage and appropriate referral for advanced care.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: