Magnetic Resonance ImagingCSDNCT05858931
Hysteroscopic Evaluation and the Clinical Outcomes of Vaginal Repair of Cesarean Section Scar Defects
An observational study of Magnetic Resonance Imaging and Hysteroscopy, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
Cesarean section scar defects (CSDs) are one of the long-term complications following cesarean section. They can be detected by transvaginal sonography, hysterosalpingography, sonohysterography and magnetic resonance imaging (MRI). Hysteroscopy is frequently used in evaluating endometrial disease. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Magnetic Resonance Imaging, Hysteroscopy
- What is being tested?
- vaginal repair
- Type of treatment
- Surgery or procedure
- How many people
- 143 participants
- Where
- 1 siteChina
- Study dates
- 2 Feb 2019to 31 Dec 2021
- How long will I take part?
- 2 Years
- 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
- Healthy volunteers accepted
- Adult
Study population: Non-pregnant patients who had one or more cesarean sections, patients who had intermenstrual spotting after the cesarean section or those in which the TRM was less than 3.0 mm at the preoperative stage
Who may be able to join
- The inclusion criteria are non-pregnant patients who had one or more cesarean sections, patients who had intermenstrual spotting after the cesarean section or those in which the TRM was less than 3.0 mm at the preoperative stage, and patients who underwent MRI and TVS to evaluate the size of the defect and the TRM before surgery
Who cannot join
- Patients who had a history of chronic diseases (such as cerebro-cardiovascular diseases, malignancies and diabetes mellitus), endocrine disorders, menstrual irregularities before cesarean section, coagulation disorders, use of intrauterine devices, sub-mucous myoma, endometrial diseases, endometrial cysts, uterine fibroids, and adenomyosis after cesarean section
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Association Between Hysteroscopic Evaluation and the Clinical Outcomes of Vaginal Repair of Cesarean Section Scar Defects
Cesarean section scar defects (CSDs) are one of the long-term complications following cesarean section. They can be detected by transvaginal sonography, hysterosalpingography, sonohysterography and magnetic resonance imaging (MRI). Hysteroscopy is frequently used in evaluating endometrial disease. However, the description of CSDs by hysteroscopy is very limited. Only a few papers about hysteroscopy evaluation have been published. This is an exploratory study to compare hysteroscopic findings with the clinical outcomes of vaginal repair of CSDs.
Read the detailed description
All women with CSD suffered from abnormal uterine bleeding and were evaluated in a standardized way with hysteroscopy before vaginal surgery. Dome-shaped CSDs could be clearly observed in all patients under hysteroscopy. We recorded the pictures of each patient under hysteroscopy and classified them. They all underwent vaginal excision and suture of CSD and will be required to undergo examinations at 3- and 6-months after surgery. Preoperative and postoperative clinical information will be collected. All patients obtain menstrual information and CSD scar size by MRI or transvaginal sonography.
- Conditions
- Magnetic Resonance Imaging, Hysteroscopy
- Being tested
- vaginal repair
- Keywords
- cesarean section scar defect, hysteroscopy, surgical outcomes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vaginal repairProcedure or surgery
vaginal repair
| Study group | Role | What they receive |
|---|---|---|
| CSD patients | All women suffered from abnormal uterine bleeding and were evaluated in a standardized way with hysteroscopy before vaginal surgery. Receives: Procedure: vaginal repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
the days of duration of menstruation
duration of menstruation
Measured: on Days: 1 month
the days of duration of menstruation
duration of menstruation
Measured: on Days: 3 month
the days of duration of menstruation
duration of menstruation
Measured: on Days: 6 month
The thickness of the residual myometrium
The thickness of the residual myometrium
Measured: on Days: 3-6 month
Secondary outcomes (1)
number of pregnancy
reproductive information by questionnaire, including abortion, delivery, childbirth, etc.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2023
- Study start2 Feb 2019
- Primary completion31 Dec 2020
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Magnetic Resonance ImagingStudies of the same condition, open and under way.
- More trials run by Xinhua Hospital, Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- 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
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 143 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xipeng Wang, Docter, Principal investigator, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05858931
- Sponsor's protocol ID
- XH-23-008
- Acronym
- CSD
- Status last verified
- Feb 2019
- First submitted
- 5 May 2023
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Hysteroscopic Evaluation and the Clinical Outcomes of Vaginal Repair of Cesarean Section Scar Defects
- ClinicalTrials.gov ID
- NCT05858931
- Acronym / sponsor ID
- CSD / XH-23-008
- Conditions
- Magnetic Resonance Imaging, Hysteroscopy
- Keywords
- cesarean section scar defect, hysteroscopy, surgical outcomes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 143 participants (actual)
- Lead sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 2 Feb 2019 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 15 May 2023 (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 defects (CSDs) are one of the long-term complications following cesarean section. They can be detected by transvaginal sonography, hysterosalpingography, sonohysterography and magnetic resonance imaging (MRI). Hysteroscopy is frequently used in evaluating endometrial disease. However, the description of CSDs by hysteroscopy is very limited. Only a few papers about hysteroscopy evaluation have been published. This is an exploratory study to compare hysteroscopic findings with the clinical outcomes of vaginal repair of CSDs.
Detailed description
All women with CSD suffered from abnormal uterine bleeding and were evaluated in a standardized way with hysteroscopy before vaginal surgery. Dome-shaped CSDs could be clearly observed in all patients under hysteroscopy. We recorded the pictures of each patient under hysteroscopy and classified them. They all underwent vaginal excision and suture of CSD and will be required to undergo examinations at 3- and 6-months after surgery. Preoperative and postoperative clinical information will be collected. All patients obtain menstrual information and CSD scar size by MRI or transvaginal sonography.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CSD patients | – | Procedure: vaginal repairAll women suffered from abnormal uterine bleeding and were evaluated in a standardized way with hysteroscopy before vaginal surgery. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Non-pregnant patients who had one or more cesarean sections, patients who had intermenstrual spotting after the cesarean section or those in which the TRM was less than 3.0 mm at the preoperative stage
Key inclusion criteria (1 listed)
- The inclusion criteria are non-pregnant patients who had one or more cesarean sections, patients who had intermenstrual spotting after the cesarean section or those in which the TRM was less than 3.0 mm at the preoperative stage, and patients who underwent MRI and TVS to evaluate the size of the defect and the TRM before surgery
Key exclusion criteria (1 listed)
- Patients who had a history of chronic diseases (such as cerebro-cardiovascular diseases, malignancies and diabetes mellitus), endocrine disorders, menstrual irregularities before cesarean section, coagulation disorders, use of intrauterine devices, sub-mucous myoma, endometrial diseases, endometrial cysts, uterine fibroids, and adenomyosis after cesarean section
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 |
|---|---|---|
| vaginal repairvaginal repair | Procedure or surgery | CSD patients |
Primary outcome
the days of duration of menstruation
Time frame: on Days: 1 month
duration of menstruation
the days of duration of menstruation
Time frame: on Days: 3 month
duration of menstruation
the days of duration of menstruation
Time frame: on Days: 6 month
duration of menstruation
The thickness of the residual myometrium
Time frame: on Days: 3-6 month
The thickness of the residual myometrium
1 secondary outcome
number of pregnancy
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
- Individual participant dataSharing planned: No
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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.
Xipeng Wang, Docter principal investigator
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 Magnetic Resonance Imaging and Hysteroscopy, 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 13 Aug 2026. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
the days of duration of menstruation (time frame: on Days: 1 month). 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 13 Aug 2026.