Role of Office Hysteroscope in Premenopausal Uterine Bleeding

Uterine Bleeding Clinical Trial

Official title:

Endometrial Characterization Using Office Hysteroscopy in Women Presenting With Abnormal Uterine Bleeding

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03205111
• Other study ID #: Office Hysteroscope
• Status: Not yet recruiting
• Phase: N/A
• First received: June 29, 2017
• Last updated: June 29, 2017
• Start date: July 2017
• Est. completion date: July 2018

Study information

• Verified date: June 2017
• Source: Assiut University
• Contact: Ahmed Z. Fahmi
• Phone: +201020440944
• Email: ahmed_zaki_1985[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: July 2018
• Est. primary completion date: June 2018
• Gender: Female
• Age group: 20 Years to 45 Years

Eligibility

Inclusion Criteria:

• Perimenopausal women complaining of abnormal uterine bleeding.

Exclusion Criteria:

• Active pelvic infections

• Medical disorders

• Bleeding tendency

• Hormonal treatment

• Pregnancy

• Contraceptive treatment

Related Conditions & MeSH terms

• Hemorrhage
• Uterine Bleeding
• Uterine Hemorrhage

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (3)

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. Review. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hysteroscopic assessment of endometrial pathology	Patterns of endometrial pathology after histopathological examination of the curretings in patients with abnormal uterine bleeding	7 days