Evaluation of TP US in Women With Prolapse | NCT03820089

Studies
Evaluation of TP US in Women With Prolapse

NCT03820089

Sponsor

Aljazeera Hospital

Status

Completed

Last Update Posted

Feb 10, 2022Actual

Enrollment

100Actual

Phase

Not provided

Conditions

Prolapse

Interventions

Ultrasonography TP

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

Jan 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 29, 2019Actual

Primary Completion Date

Jan 20, 2020Actual

Completion Date

Jan 25, 2020Actual

First Submitted Date

Jan 25, 2019

First Submission Date that Met QC Criteria

Jan 25, 2019

First Posted Date

Jan 29, 2019Actual

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

Jan 27, 2022

Last Update Posted Date

Feb 10, 2022Actual

Name	Class
Cairo University	OTHER

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

Many women suffers from uterine and vaginal prolapse Usually they suffer from these symotoms in menopause

Detailed Description

The most common cause of pelvic organ prolapse is multiple pregnancy and multiparity

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

8 Weeks

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ultrasonography TP	Diagnostic Test	TP us will be made to the included women

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The number of women who will be properly diagnosed with prolapse by TP us	The accuracy of TP US in diagnosing the prolapse	within 2 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Women with history of normal delivery Age between 25 to 75 years

Exclusion Criteria:

women with cesarean deliveries

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Females who have pelvic organ prolapse

Minimum Age

25 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Women who complains from genital prolapse with previous normal deliveries

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mahmoud Alalfy, PhD	Algazeerah hospital -Location (Giza -Egypt ) and National Research centre egypt	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Algazeerah and Kasralainy hospital		Giza			Egypt

Condition Browse Module

MeSH Terms

ID	Term
D011391	Prolapse

Ancestor Terms

ID	Term
D020763	Pathological Conditions, Anatomical
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D014463	Ultrasonography

Ancestor Terms

ID	Term
D003952	Diagnostic Imaging
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided