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Ultrasound Elastography Application in Cesarean Section Scar Defect

Sponsor
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05363735
Collaborator
(none)
100
Enrollment
1
Location
37
Anticipated Duration (Months)
2.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Ultrasound Elastography

Study Design

Study Type:
Observational
Anticipated Enrollment :
100 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Ultrasound Elastography Application in the Assessment of Cesarean Section Scar Defect.
Anticipated Study Start Date :
Jun 1, 2022
Anticipated Primary Completion Date :
Jun 30, 2024
Anticipated Study Completion Date :
Jun 30, 2025

Arms and Interventions

Arm Intervention/Treatment
Ultrasound Elastography

Patients will be examined by ultrasound elastography.

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

Outcome Measures

Primary Outcome Measures

  1. thickness of the remaining muscular layer [4 weeks before vaginal repair of CSD]

    The thickness of the remaining muscular layer is measured by ultrasound

  2. thickness of the remaining muscular layer [12 weeks after vaginal repair of CSD]

    The thickness of the remaining muscular layer is measured by ultrasound

  3. strain ratio (SR) [4 weeks before vaginal repair of CSD]

    the ratio of mean strain in the lesion to the adjacent background tissue

  4. strain ratio (SR) [12 weeks after vaginal repair of CSD]

    the ratio of mean strain in the lesion to the adjacent background tissue

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 40 Years
Sexes Eligible for Study:
Female
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine Shanghai Shanghai China 200092

Sponsors and Collaborators

  • 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier:
NCT05363735
Other Study ID Numbers:
  • XH-21-015
First Posted:
May 6, 2022
Last Update Posted:
May 6, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of May 6, 2022