Ultrasound Elastography Application in Cesarean Section Scar Defect

Ultrasound Elastography Application in the Assessment of Cesarean Section Scar Defect.

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.

Study Overview

• Status: Withdrawn
• Conditions: Cesarean Section; Dehiscence
• Intervention / Treatment: Other: Ultrasound Elastography

• Study Type: Observational

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200092
      • Xinhua Hospital Affiliated To Shanghai Jiaotong University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

women who were diagnosed with CSD

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Ultrasound Elastography; Patients will be examined by ultrasound elastography.	Other: Ultrasound Elastography; Patients will be examined by ultrasound elastography.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
• Investigators: Study Director: Wang Xipeng, Dr, Xinhua Hospital Affiliated To Shanghai Jiaotong University School of Medicine

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2022
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: March 19, 2022
• First Submitted That Met QC Criteria: May 5, 2022
• First Posted (Actual): May 6, 2022

Study Record Updates

• Last Update Posted (Actual): April 19, 2024
• Last Update Submitted That Met QC Criteria: April 17, 2024
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: XH-21-015

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No