Saline Sonohystrography and Office Hysteroscopy in Evaluation of Cases of Abnormal Uterine Bleeding

NCT ID: NCT03135353

Last Updated: 2018-10-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-20

Study Completion Date

2018-11-30

Brief Summary

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comparing the efficacy of the 3D saline infusion sonohysterography to the diagnostic office hysteroscopy in the diagnosis of the cause of abnormal uterine bleeding in females during their reproductive age

Detailed Description

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Conditions

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Gynecologic Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Investigators

Study Groups

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3D saline infusion sonohysterography

participants presenting with abnormal uterine bleeding will undergo 3D saline infusion sonohysterography

Group Type EXPERIMENTAL

3D saline infusion sonohysterography

Intervention Type DEVICE

instillation of saline in the uterine cavity using pediatric foley's catheter, then performing 3D ultrasound scan of the uterus and adenexae

Office hysteroscopy

after undergoing 3D SIS, cases would undergo office hysteroscopy and the investigator would be blinded to the results of SIS

Group Type EXPERIMENTAL

Office Hysteroscopy

Intervention Type DEVICE

an outpatient procedure done to assess the uterine cavity using the office hysteroscopy

Interventions

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3D saline infusion sonohysterography

instillation of saline in the uterine cavity using pediatric foley's catheter, then performing 3D ultrasound scan of the uterus and adenexae

Intervention Type DEVICE

Office Hysteroscopy

an outpatient procedure done to assess the uterine cavity using the office hysteroscopy

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* female aged between 20 and 45 years
* with no medical disorders
* approving to participate in the study

Exclusion Criteria

* vaginal or cervical lesions
* history or suspicion of PID
* IUD users
* bleeding disorders
* on anticoagulant therapy
* irregular use of oral contraceptive pills
Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Woman's Health University Hospital, Egypt

OTHER

Sponsor Role lead

Responsible Party

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Dina Mohamed Refaat Dakhly

Assistant Professor Obstetrics and Gynecology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dina MR Dakhly, MD

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

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Kasr el ainy hospital

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Dina MR Dakhly, MD

Role: CONTACT

01003498919 ext. 002

Yasmin A Bassiouny, MD

Role: CONTACT

01001720751 ext. 002

Facility Contacts

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Dina M Dakhly, M.D.

Role: primary

01003498919 ext. +2

Other Identifiers

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ED200417

Identifier Type: -

Identifier Source: org_study_id

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