Ultrasound Elastography Application in Cesarean Section Scar Defect

Cesarean Section; Dehiscence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05363735
• Other study ID #: XH-21-015
• Status: Withdrawn
• Start date: June 1, 2022
• Est. completion date: June 30, 2025

Study information

• Verified date: May 2022
• Source: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 30, 2025
• Est. primary completion date: June 30, 2024
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cesarean Section; Dehiscence

Intervention

Other:
• Ultrasound Elastography
Patients will be examined by ultrasound elastography.

Locations

Country	Name	City	State
China	Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

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