Cesarean Section; DehiscenceNCT05363735
Ultrasound Elastography Application in Cesarean Section Scar Defect
An observational study of Cesarean Section; Dehiscence, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Cesarean Section; Dehiscence
- What is being tested?
- Ultrasound Elastography
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2022to 30 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Adult
Study population: women who were diagnosed with CSD
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200092
About this study
Official title: 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.
- Conditions
- Cesarean Section; Dehiscence
- Being tested
- Ultrasound Elastography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound ElastographyOther
Patients will be examined by ultrasound elastography.
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound Elastography | Patients will be examined by ultrasound elastography. Receives: Other: Ultrasound Elastography |
What is being measured
The primary outcome is the main question the study is designed to answer.
thickness of the remaining muscular layer
The thickness of the remaining muscular layer is measured by ultrasound
Measured: 4 weeks before vaginal repair of CSD
thickness of the remaining muscular layer
The thickness of the remaining muscular layer is measured by ultrasound
Measured: 12 weeks after vaginal repair of CSD
strain ratio (SR)
the ratio of mean strain in the lesion to the adjacent background tissue
Measured: 4 weeks before vaginal repair of CSD
strain ratio (SR)
the ratio of mean strain in the lesion to the adjacent background tissue
Measured: 12 weeks after vaginal repair of CSD
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2022
- Study start1 Jun 2022 (estimated)
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Jun 2025 (estimated)
Why it stopped: Device can't meet the requirements
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean Section; DehiscenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wang Xipeng, Dr, Study director, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05363735
- Sponsor's protocol ID
- XH-21-015
- Status last verified
- May 2022
- First submitted
- 19 Mar 2022
- Last updated
- 19 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Elastography Application in the Assessment of Cesarean Section Scar Defect.
- ClinicalTrials.gov ID
- NCT05363735
- Acronym / sponsor ID
- XH-21-015
- Conditions
- Cesarean Section; Dehiscence
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Device can't meet the requirements
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 1 Jun 2022 (estimated)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 6 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ultrasound Elastography | – | Other: Ultrasound ElastographyPatients will be examined by ultrasound elastography. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- women who were diagnosed with CSD
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound ElastographyPatients will be examined by ultrasound elastography. | Other | Ultrasound Elastography |
Primary outcome
thickness of the remaining muscular layer
Time frame: 4 weeks before vaginal repair of CSD
The thickness of the remaining muscular layer is measured by ultrasound
thickness of the remaining muscular layer
Time frame: 12 weeks after vaginal repair of CSD
The thickness of the remaining muscular layer is measured by ultrasound
strain ratio (SR)
Time frame: 4 weeks before vaginal repair of CSD
the ratio of mean strain in the lesion to the adjacent background tissue
strain ratio (SR)
Time frame: 12 weeks after vaginal repair of CSD
the ratio of mean strain in the lesion to the adjacent background tissue
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wang Xipeng, Dr study director
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cesarean Section; Dehiscence, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 19 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
thickness of the remaining muscular layer (time frame: 4 weeks before vaginal repair of CSD). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2024.