Hysteroscopic Evaluation and the Clinical Outcomes of Vaginal Repair of Cesarean Section Scar Defects

Magnetic Resonance Imaging Clinical Trial

— CSD  

Official title:

Association Between Hysteroscopic Evaluation and the Clinical Outcomes of Vaginal Repair of Cesarean Section Scar Defects

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05858931
• Other study ID #: XH-23-008
• Status: Not yet recruiting
• Start date: June 1, 2024
• Est. completion date: December 31, 2027

Study information

• Verified date: May 2023
• Source: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
• Contact: Xipeng Wang, Doctor
• Phone: 86-021-25078999
• Email: wangxipeng[@]xinhuamed.com.cn
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 31, 2027
• Est. primary completion date: May 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Hysteroscopy
• Magnetic Resonance Imaging

Intervention

Procedure:
• vaginal repair
vaginal repair

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the days of duration of menstruation	duration of menstruation	on Days: 1 month
Primary	the days of duration of menstruation	duration of menstruation	on Days: 3 month
Primary	the days of duration of menstruation	duration of menstruation	on Days: 6 month
Primary	The thickness of the residual myometrium	The thickness of the residual myometrium	on Days: 3-6 month
Secondary	number of pregnancy	reproductive information by questionnaire, including abortion, delivery, childbirth, etc.	3 years