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

• Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05187728
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Anticipated Duration (Months): 24
• Patients Per Site Per Month: 4.2

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Magnetic Resonance Imaging; Cesarean Section; Complications, Wound, Dehiscence	Other: No Intervention

Detailed 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

Study Design

• Study Type: Observational
• Anticipated Enrollment: 100 participants
• Observational Model: Ecologic or Community
• Time Perspective: Retrospective
• Official Title: Association Between the Occurrence of Adenomyosis and the Clinical Outcomes of Vaginal Repair ofCesareanSectionScar Defects:An Observational Study
• Anticipated Study Start Date: Jan 1, 2022
• Anticipated Primary Completion Date: Dec 31, 2023
• Anticipated Study Completion Date: Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
adenomyosis group CSD with adenomyosis	Other: No Intervention; No more intervention will be given.
non-adenomyosis group CSD without adenomyosis	Other: No Intervention; No more intervention will be given.

Outcome Measures

Primary Outcome Measures

1. Mean duration of menstruation [on Days: 30]

   Mean duration of menstruation

2. Mean duration of menstruation [on Days: 60]

   Mean duration of menstruation

3. Mean duration of menstruation [on Days: 90]

   Mean duration of menstruation

4. The thickness of the residual myometrium [on Days: 90]

   The thickness of the residual myometrium

Secondary Outcome Measures

1. reproductive information [3 years]

   reproductive information by questionnaire, including abortion, delivery, childbirth, etc.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 40 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine	Shanghai	Shanghai	China	200092

Sponsors and Collaborators

• Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
• ClinicalTrials.gov Identifier: NCT05187728
• Other Study ID Numbers: XH-21-009
• First Posted: Jan 12, 2022
• Last Update Posted: Jan 12, 2022
• Last Verified: Dec 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine: Magnetic Resonance Imaging; cesarean scar defects; vaginal repair
• Additional relevant MeSH terms: Adenomyosis

Study Results

No Results Posted as of Jan 12, 2022