Hysteroscopic Evaluation and the Clinical Outcomes of Vaginal Repair of Cesarean Section Scar Defects (CSD)
August 11, 2026 updated by: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
143
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Shanghai, China
- Xinhua Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
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
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
CSD patients
All women suffered from abnormal uterine bleeding and were evaluated in a standardized way with hysteroscopy before vaginal surgery.
|
vaginal repair
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The thickness of the residual myometrium
Time Frame: on Days: 3-6 month
|
The thickness of the residual myometrium
|
on Days: 3-6 month
|
|
the days of duration of menstruation
Time Frame: on Days: 1 month
|
duration of menstruation
|
on Days: 1 month
|
|
the days of duration of menstruation
Time Frame: on Days: 3 month
|
duration of menstruation
|
on Days: 3 month
|
|
the days of duration of menstruation
Time Frame: on Days: 6 month
|
duration of menstruation
|
on Days: 6 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
number of pregnancy
Time Frame: 3 years
|
reproductive information by questionnaire, including abortion, delivery, childbirth, etc.
|
3 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Xipeng Wang, Docter, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 2, 2019
Primary Completion (Actual)
December 31, 2020
Study Completion (Actual)
December 31, 2021
Study Registration Dates
First Submitted
May 5, 2023
First Submitted That Met QC Criteria
May 5, 2023
First Posted (Actual)
May 15, 2023
Study Record Updates
Last Update Posted (Actual)
August 13, 2026
Last Update Submitted That Met QC Criteria
August 11, 2026
Last Verified
February 1, 2019
More Information
Terms related to this study
Other Study ID Numbers
- XH-23-008
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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