Role of Office Hysteroscope in Premenopausal Uterine Bleeding

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

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.

Study Overview

• Status: Unknown
• Conditions: 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.

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 45 years (Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: Female

• 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.

Description

Inclusion Criteria:

• Perimenopausal women complaining of abnormal uterine bleeding.

Exclusion Criteria:

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hysteroscopic assessment of endometrial pathology	Patterns of endometrial pathology after histopathological examination of the curretings in patients with abnormal uterine bleeding	7 days

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Principal Investigator: Ahmed Z. Fahmi, Assiut University; Study Chair: Essam M. Abdallah, Profosser, Assiut University; Study Director: Hazem S. Mohammed, Professor, Assiut University; Study Director: Kamal M. Zahran, Professor, Assiut University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2017
• Primary Completion (Anticipated): June 1, 2018
• Study Completion (Anticipated): July 1, 2018

Study Registration Dates

• First Submitted: June 29, 2017
• First Submitted That Met QC Criteria: June 29, 2017
• First Posted (Actual): July 2, 2017

Study Record Updates

• Last Update Posted (Actual): July 2, 2017
• Last Update Submitted That Met QC Criteria: June 29, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Uterine Diseases; Hemorrhage; Uterine Hemorrhage
• Other Study ID Numbers: Office Hysteroscope

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No