Cesarean Scar Defect (CSD); Prevalence, Risk Factors And... | NCT04605328

Studies
Cesarean Scar Defect (CSD); Prevalence, Risk Factors And Possible Associated Symptoms

NCT04605328

Sponsor

Assiut University

Status

Unknown status

Last Update Posted

Nov 3, 2020Actual

Enrollment

225Estimated

Phase

Not provided

Conditions

Cesarean Section Complications

Interventions

Two dimension and three dimension ultrasound

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

Oct 2020

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

Dec 1, 2020Estimated

Primary Completion Date

Dec 1, 2021Estimated

Completion Date

Dec 30, 2021Estimated

First Submitted Date

Oct 5, 2020

First Submission Date that Met QC Criteria

Oct 21, 2020

First Posted Date

Oct 28, 2020Actual

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

Oct 31, 2020

Last Update Posted Date

Nov 3, 2020Actual

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 study aims to detect the incidence of Cesarean Scar Defect (CSD) in women undergoing CS in Women Health Hospital (WHH), assiut University, to identify risk factors for development of CSD and identify the possible gynaecological symptoms related to CSD.

Detailed Description

All eligible women, who will undergo CS in Women Health Hospital (WHH) will be seen on regular visits to detect the presence of CSD by ultrasound and identify its characters and a questionnaire will be fulfilled by the candidates about the gynecological symptoms related to CSD and appeared after CS.

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

225Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Two dimension and three dimension ultrasound	Other	Patient will undergo 2D and 3D ultrasound evaluation after CS for detection of CSD

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
the incidence of CSD in Women health Hospital	the incidence of CSD in Women health Hospital	1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All women who will undergo transverse lower segment cesarean section after 28 weeks gestational age (electively and Emergency), after counseling and written consent

Exclusion Criteria:

Rupture uterus (unscarred or scarred).
Upper segment CS.
Vertical lower segment CS.

Accepts Healthy Volunteers

Yes

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

Patients admitted to Women Health Hospital for performing CS will be seen on regular visits for ultrasound scan for detection of CSD

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Mohamed Bahaa El-Dine, Master	Contact	++201022422960		midobahaa39@yahoo.com

Overall Officials

Name	Affiliation	Role
Ayman shamaash, PHD	Assiut University	Study Director
Sherif Badran, MD	Assiut University	Study Chair

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided