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Ultrasound Elastography Application in Cesarean Section Scar Defect
1 other identifier
observational
N/A
1 country
1
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.
Trial Health
Trial Health Score
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Started Jun 2022
Typical duration for all trials
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 19, 2022
CompletedFirst Posted
Study publicly available on registry
May 6, 2022
CompletedStudy Start
First participant enrolled
June 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2025
CompletedApril 19, 2024
May 1, 2022
2.1 years
March 19, 2022
April 17, 2024
Conditions
Outcome Measures
Primary Outcomes (4)
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
Study Arms (1)
Ultrasound Elastography
Patients will be examined by ultrasound elastography.
Interventions
Patients will be examined by ultrasound elastography.
Eligibility Criteria
women who were diagnosed with CSD
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200092, China
Study Officials
- STUDY DIRECTOR
Wang Xipeng, Dr
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 19, 2022
First Posted
May 6, 2022
Study Start
June 1, 2022
Primary Completion
June 30, 2024
Study Completion
June 30, 2025
Last Updated
April 19, 2024
Record last verified: 2022-05