Role of Office Hysteroscope in Premenopausal Uterine Blee... | NCT03205111

Studies
Role of Office Hysteroscope in Premenopausal Uterine Bleeding

NCT03205111

Sponsor

Assiut University

Status

Unknown status

Last Update Posted

Jul 2, 2017Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Uterine Bleeding

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2017Estimated

Primary Completion Date

Jun 2018Estimated

Completion Date

Jul 2018Estimated

First Submitted Date

Jun 29, 2017

First Submission Date that Met QC Criteria

Jun 29, 2017

First Posted Date

Jul 2, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 29, 2017

Last Update Posted Date

Jul 2, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Not provided

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

45 Years

Standard Ages

Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ahmed Z. Fahmi	Contact	+201020440944		ahmed_zaki_1985@yahoo.com

Overall Officials

Name	Affiliation	Role
Ahmed Z. Fahmi	Assiut University	Principal Investigator
Essam M. Abdallah, Profosser	Assiut University	Study Chair
Hazem S. Mohammed, Professor

Locations

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25007322	Result	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.
22830167	Result	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.

ID	Term
D014591	Uterine Diseases
D005831	Genital Diseases, Female
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications