Association Between the Adenomyosis and the Clinical Outcomes of Vaginal Repair of CesareanSectionScar Defects
Association Between the Occurrence of Adenomyosis and the Clinical Outcomes of Vaginal Repair ofCesareanSectionScar Defects:An Observational Study
1 other identifier
observational
100
1 country
1
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.
Trial Health
Trial Health Score
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participants targeted
Target at P50-P75 for all trials
Started Jan 2022
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 7, 2021
CompletedStudy Start
First participant enrolled
January 1, 2022
CompletedFirst Posted
Study publicly available on registry
January 12, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2023
CompletedJanuary 12, 2022
December 1, 2021
2 years
December 7, 2021
January 11, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Mean duration of menstruation
Mean duration of menstruation
on Days: 30
Mean duration of menstruation
Mean duration of menstruation
on Days: 60
Mean duration of menstruation
Mean duration of menstruation
on Days: 90
The thickness of the residual myometrium
The thickness of the residual myometrium
on Days: 90
Secondary Outcomes (1)
reproductive information
3 years
Study Arms (2)
adenomyosis group
CSD with adenomyosis
non-adenomyosis group
CSD without adenomyosis
Interventions
Eligibility Criteria
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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200092, China
MeSH Terms
Conditions
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- ECOLOGIC OR COMMUNITY
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 7, 2021
First Posted
January 12, 2022
Study Start
January 1, 2022
Primary Completion
December 31, 2023
Study Completion
December 31, 2023
Last Updated
January 12, 2022
Record last verified: 2021-12
Data Sharing
- IPD Sharing
- Will not share