Association Between the Adenomyosis and the Clinical Outcomes of Vaginal Repair of CesareanSectionScar Defects

Magnetic Resonance Imaging Clinical Trial

Official title:

Association Between the Occurrence of Adenomyosis and the Clinical Outcomes of Vaginal Repair ofCesareanSectionScar Defects:An Observational Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05187728
• Other study ID #: XH-21-009
• Status: Not yet recruiting
• Start date: January 1, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: December 2021
• Source: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
• Contact: Xipeng Wang, Dr
• Phone: 862125078999
• Email: wangxipeng[@]xinhuamed.com.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To examine the correlation between the occurrence of adenomyosis and the outcome of vaginal repair of cesarean section scar defects (CSD), women with CSD will be enrolled in this retrospective observational cohort study. According to preoperative magnetic resonance imaging (MRI) findings, patients will be divided into two groups, the adenomyosis group and the non-adenomyosis group. They all will have 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.

Description:

Women with CSD will be enrolled in this study. According to preoperative magnetic resonance imaging (MRI) findings, patients will be divided into two groups, the adenomyosis group and the non-adenomyosis group. 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. Optimal healing was defined as a duration of menstruation of no more than 7 days and a TRM of no less than 5.30 mm after vaginal repair

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• 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

• Adenomyosis
• Cesarean Section; Complications, Wound, Dehiscence
• Magnetic Resonance Imaging

Intervention

Other:
• No Intervention
No more intervention will be given.

Locations

Country	Name	City	State
China	Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine	Shanghai	Shanghai

Sponsors (1)

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

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean duration of menstruation	Mean duration of menstruation	on Days: 30
Primary	Mean duration of menstruation	Mean duration of menstruation	on Days: 60
Primary	Mean duration of menstruation	Mean duration of menstruation	on Days: 90
Primary	The thickness of the residual myometrium	The thickness of the residual myometrium	on Days: 90
Secondary	reproductive information	reproductive information by questionnaire, including abortion, delivery, childbirth, etc.	3 years