Uterine Cavity Volume Measuring With Sonohysterography: A... | NCT03777566

Studies
Uterine Cavity Volume Measuring With Sonohysterography: A New Objective Method

NCT03777566

Sponsor

Ain Shams University

Status

Unknown status

Last Update Posted

Dec 23, 2019Actual

Enrollment

185Estimated

Phase

Not provided

Conditions

Cavity

Interventions

sonohysterography

Countries

Egypt

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

Dec 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 10, 2019Actual

Primary Completion Date

Dec 2019Estimated

Completion Date

Jan 2020Estimated

First Submitted Date

Dec 14, 2018

First Submission Date that Met QC Criteria

Dec 14, 2018

First Posted Date

Dec 17, 2018Actual

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

Dec 20, 2019

Last Update Posted Date

Dec 23, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

Measuring of uterine cavity volume using sonohysterography will be done in two groups of patients, Group A included 35 patients for home hysterectomy were indicated and group B includes 150 infertile patients in the childbearing age.

Detailed Description

Uterine cavity volume will be measured in group A before and after hysterectomy, and in the group, B will be measured using sonohysterography only using a mathematical method of the sum of a volume of a cone and part of a sphere.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Day

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

185Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
group A		35 patients with an indication for hysterectomy without gross uterine pathology	Diagnostic Test: sonohysterography
group B		150 infertile patients in the childbearing age without gross uterine pathology	Diagnostic Test: sonohysterography

Interventions

Name	Type	Description	Arm Group Labels	Other Names
sonohysterography	Diagnostic Test	sonohysterography with measuring the uterine cavity volume	group A group B

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
calculation of uterine cavity volume with an objective method	measuring uterine cavity volume objectively	one day

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients without any gross pathology within the uterus.
Patients admitted for hysterectomy.
Patients agreed with written consent to participate in the study.

Exclusion Criteria:

Virgins.
Pregnancy.
Systemic blood disease.
Any clinical evidence of cervical, uterine or tubal infection.
Refusal to undergo saline infusion sonography.
Any gross uterine pathology diagnosed clinically or with sonography.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Women undergo sonohysterography for gynecologic indication without gross uterine pathology.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Mohamed I Amer, MD	Contact	00201001519370		mohamed_amer810@yahoo.com

Overall Officials

Name	Affiliation	Role
Mohamed I Amer, MD	Ain Shams University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
AIn Shams University Maternity Hospital	Recruiting	Cairo		11357	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided