Clinical trial NCT05858931: Hysteroscopic Evaluation and the Clinical Outcomes of Vaginal Repair of Cesarean Section Scar Defects
Official title: Association Between Hysteroscopic Evaluation and the Clinical Outcomes of Vaginal Repair of Cesarean Section Scar Defects
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Magnetic Resonance Imaging
Hysteroscopy
Keywords: cesarean section scar defect
hysteroscopy
surgical outcomes
Lead sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2023-05-15
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
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

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: the days of duration of menstruation
timeFrame: on Days: 1 month
measure: the days of duration of menstruation
timeFrame: on Days: 3 month
measure: the days of duration of menstruation
timeFrame: on Days: 6 month
measure: The thickness of the residual myometrium
timeFrame: on Days: 3-6 month
Secondary outcomes:
measure: number of pregnancy
timeFrame: 3 years
Other outcomes:
Locations:
Study officials:
affiliation: Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
name: Xipeng Wang, Docter
role: PRINCIPAL_INVESTIGATOR
References: