Clinical trial NCT03205111: Role of Office Hysteroscope in Premenopausal Uterine Bleeding
Official title: Endometrial Characterization Using Office Hysteroscopy in Women Presenting With Abnormal Uterine Bleeding
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Uterine Bleeding
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-07-02
Enrollment: 100
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 100 women between 20 and 45 years of age who presented with complaints of abnormal uterine bleeding will be recruited for this study.

Brief summary: The aim of this study is to photographically characterize the endometrium in patients presenting with abnormal uterine bleeding at age group from 20 to 45 years old.

and compare dilatation and curettage with hysteroscopy in obtaining an accurate diagnosis of the etiology of abnormal uterine bleeding.

Detailed description: Menstrual dysfunction is the cause of discomfort and disturbed healthy lifestyle. Abnormal uterine bleeding (AUB) is considered as a common problem in premenopausal women. AUB is defined as bleeding from the uterine that is abnormal in volume, regularity, and/or timing.

There are various diagnostic modalities available in the market, ranging from traditional dilation and curettage (D\&C), transvaginal sonography, hysteroscopy and saline infusion sonography. Dilation and curettage is the most widely used simple day care procedure for histological evaluation of the endometrial. It was once considered as the gold standard of investigating women with AUB.

Office hysteroscopy is a very useful technique for diagnosis and treatment of uterine pathology in an office-based environment. It is directly related to the technological explosion, which during the last years has further evolved and given us the opportunity to perform hysteroscopy without providing general anesthesia or sedation to the patients, due to the narrow width of the latest generation hysteroscopes. Hysteroscopic inspection of uterine cavity is a simple and well accepted method. The direct real time visualization, real-color, hydrated, well-illuminated, and augmented vision of the uterine cavity make this diagnostic tool very accurate to detect minute focal endometrial pathology and small lesions and helping us to take well guided direct biopsies.

Eligibility criteria: Inclusion Criteria:

* Perimenopausal women complaining of abnormal uterine bleeding.

Exclusion Criteria:

* Active pelvic infections
* Medical disorders
* Bleeding tendency
* Hormonal treatment
* Pregnancy
* Contraceptive treatment

Primary outcomes:
measure: Hysteroscopic assessment of endometrial pathology
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: Ahmed Z. Fahmi
role: PRINCIPAL_INVESTIGATOR
affiliation: Assiut University
name: Essam M. Abdallah, Profosser
role: STUDY_CHAIR
affiliation: Assiut University
name: Hazem S. Mohammed, Professor
role: STUDY_DIRECTOR
affiliation: Assiut University
name: Kamal M. Zahran, Professor
role: STUDY_DIRECTOR
References:
citation: Bennett AR, Gray SH. What to do when she's bleeding through: the recognition, evaluation, and management of abnormal uterine bleeding in adolescents. Curr Opin Pediatr. 2014 Aug;26(4):413-9. doi: 10.1097/MOP.0000000000000121.
citation: Saadia A, Mubarik A, Zubair A, Jamal S, Zafar A. Diagnostic accuracy of endometrial curettage in endometrial pathology. J Ayub Med Coll Abbottabad. 2011 Jan-Mar;23(1):129-31.
citation: Zhu HL, Liang XD, Wang JL, Cui H, Wei LH. Hysteroscopy and directed biopsy in the diagnosis of endometrial carcinoma. Chin Med J (Engl). 2010 Dec;123(24):3524-8.