Hysteroscopic Evaluation of Cesarean Scar Defect | NCT03780699

Studies
Hysteroscopic Evaluation of Cesarean Scar Defect

NCT03780699

Sponsor

Ain Shams University

Status

Unknown status

Last Update Posted

Dec 20, 2018Actual

Enrollment

200Estimated

Phase

Not provided

Conditions

Cesarean Scar Defect

Interventions

Diagnostic hysteroscopic examination

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 2018

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

Apr 1, 2018Actual

Primary Completion Date

Apr 1, 2019Estimated

Completion Date

Sep 1, 2019Estimated

First Submitted Date

Dec 16, 2018

First Submission Date that Met QC Criteria

Dec 18, 2018

First Posted Date

Dec 19, 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 18, 2018

Last Update Posted Date

Dec 20, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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 identify hysteroscopic findings of cesarean scar defect in women underwent at least one prior cesarean section and its relation to any of the different un explained gynecological presentations.

Detailed Description

Not provided

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

200Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Diagnostic hysteroscopic examination	Procedure	The hysteroscopic criteria of the cesarean scar defect will be observed with comment on different niche features

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
cesarean section scar defect shapes	different shapes of CS defect and its relation to post menstrual spotting	at least six months after CS

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age between 18 and 35 years.
Had at least one prior cesarean section

Exclusion Criteria:

History of uterine surgery that could change the cavity anatomy.
Uterine Abnormalities as submucous fibroid, endometrial or endocervical Polyps.
Recent intra-uterine contraceptive device (IUCD) in place.
Known history of endometriosis

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

35 Years

Standard Ages

Adult

Study Population

The study will be carried on 200 patients with cesarean scar defect recruited from Early Cancer Detection Unit.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Radwa R Ali, MD	Contact	01283492979	02002	radwaebed@yahoo.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
AinShams university maternity hospital	Recruiting	Cairo	Abbassya	11566	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