Ultrasound Elastography Application in Cesarean Section S... | NCT05363735

Studies
Ultrasound Elastography Application in Cesarean Section Scar Defect

NCT05363735

Sponsor

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Status

Withdrawn

Last Update Posted

Apr 19, 2024Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Cesarean Section; Dehiscence

Interventions

Ultrasound Elastography

Countries

China

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

May 2022

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Device can't meet the requirements

Expanded Access Info

Start Date

Jun 1, 2022Estimated

Primary Completion Date

Jun 30, 2024Estimated

Completion Date

Jun 30, 2025Estimated

First Submitted Date

Mar 19, 2022

First Submission Date that Met QC Criteria

May 5, 2022

First Posted Date

May 6, 2022Actual

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

Apr 17, 2024

Last Update Posted Date

Apr 19, 2024Actual

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

Cesarean Section Scar Defect(CSD) is one of the complications after cesarean section. CSD will cause many long term complications, such as abnormal uterine bleeding, infertility, uterine scar pregnancy and uterine rupture. Transvaginal ultrasound was used to detect uterine scar defects commonly. Ultrasound elastography is a modern imaging technique that has developed rapidly in recent years. Thus, this study intend to investigate the application of Ultrasound Elastography in Cesarean Section Scar Defect.

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

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Ultrasound Elastography		Patients will be examined by ultrasound elastography.	Other: Ultrasound Elastography

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ultrasound Elastography	Other	Patients will be examined by ultrasound elastography.	Ultrasound Elastography

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
thickness of the remaining muscular layer	The thickness of the remaining muscular layer is measured by ultrasound	4 weeks before vaginal repair of CSD
thickness of the remaining muscular layer	The thickness of the remaining muscular layer is measured by ultrasound	12 weeks after vaginal repair of CSD
strain ratio (SR)	the ratio of mean strain in the lesion to the adjacent background tissue	4 weeks before vaginal repair of CSD
strain ratio (SR)	the ratio of mean strain in the lesion to the adjacent background tissue	12 weeks after vaginal repair of CSD

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Clearly diagnosed with CSD
No serious medical problems (important viscera function in the normal range). uterine fibroids no more than 5cm
Sign the informed consent.

Exclusion Criteria:

Indefinite diagnosis.
Malignant tumors.
With severe medical problems (severe liver disease, kidney disease, respiratory diseases, heart disease or uncontrolled diabetes, epilepsy, etc., dysfunction of important organs).
Pregnant.
Mental diseases.
Unwilling to comply with the research plan.

Accepts Healthy Volunteers

Not provided

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

women who were diagnosed with CSD

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Wang Xipeng, Dr	Xinhua Hospital, Shanghai Jiao Tong University School of Medicine	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine		Shanghai	Shanghai Municipality	200092	China

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