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

NCT ID: NCT05187728

Last Updated: 2022-01-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-01-01

Study Completion Date

2023-12-31

Brief Summary

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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.

Detailed Description

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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

Conditions

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Magnetic Resonance Imaging Cesarean Section; Complications, Wound, Dehiscence

Study Design

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Observational Model Type

ECOLOGIC_OR_COMMUNITY

Study Time Perspective

RETROSPECTIVE

Study Groups

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adenomyosis group

CSD with adenomyosis

No Intervention

Intervention Type OTHER

No more intervention will be given.

non-adenomyosis group

CSD without adenomyosis

No Intervention

Intervention Type OTHER

No more intervention will be given.

Interventions

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No Intervention

No more intervention will be given.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Central Contacts

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Xipeng Wang, Dr

Role: CONTACT

862125078999 ext. 8213

Other Identifiers

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XH-21-009

Identifier Type: -

Identifier Source: org_study_id

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