Ignite Creation Date:
2024-07-17 @ 11:03 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06485180
Status:
COMPLETED
Last Update Posted:
2024-07-10
First Post:
2024-06-21
Brief Title:
Comparative Effectiveness of Uterine Repair Surgery on Preventing Recurrence of Cesarean Sar Pregnancy
Sponsor:
Womens Hospital School Of Medicine Zhejiang University
Organization:
Womens Hospital School Of Medicine Zhejiang University
Study Overview
Official Title:
Womens Hospital Zhejiang University School of Medicine
Status:
COMPLETED
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CECS
Brief Summary:
The goal of this observational study is to learn about the long-term effects of resection surgery which is cesarean scar pregnancyCSP excision plus hysterotomy closure in CSP patients to treat their CSP The main question it aims to answer is
Does resection surgery lower next recurrence of CSP than conservative surgery which leaves the uterine niche alone Participants already underwent resection surgery or conservative surgery will answer survey questions about their next pregnancy for 3 years
Does resection surgery lower next recurrence of CSP than conservative surgery which leaves the uterine niche alone Participants already underwent resection surgery or conservative surgery will answer survey questions about their next pregnancy for 3 years
Detailed Description:
Background Cesarean scar pregnancy CSP is a rare but prognostically severe obstetrics and gynecology complication There have been well-developed techniques for the initial treatment of CSP However the recurrence of CSP remains a challenge for clinicians Currently the conservative surgery and resection surgery has been widely applied in clinical practice However there is no published data exist regarding whether hysterotomy closure technique for CSP can prevent recurrence of CSP The investigators aimed to systematically evaluate the value of hysterotomy closure on the prevent on recurrent CSP and improve pregnancy outcome
Methods In this multi-centre retrospective cohort study participants hospitalized three hospitals in China due to CSP from January 1 2019 to December 31 2022 were collected and their pregnancy outcomes were followed up until January 31 2024 International and Chinese classifications were determined based on the results of three-dimensional ultrasound A total of 606 CSP patients who met the criteria were included in our analysis Based on Chinese classification 171 CSP I 404 CSP II and 31 CSP III were identified Based on international classification 575 endogenous CSP and 31 exogenous CSP were identified The investigators compared the baseline data of two groups of subjects regarding fertility excluding cases with no fertility requirements or incomplete information Effectiveness was used to compare the resection surgery and conservative surgery in clinical practice Survival analysis was used to examine the relationship among post-surgical pregnancy interval and recurrent CSP The primary outcome was the effectiveness which included successful termination of the current CSP and non-CSP in the next pregnancy
Methods In this multi-centre retrospective cohort study participants hospitalized three hospitals in China due to CSP from January 1 2019 to December 31 2022 were collected and their pregnancy outcomes were followed up until January 31 2024 International and Chinese classifications were determined based on the results of three-dimensional ultrasound A total of 606 CSP patients who met the criteria were included in our analysis Based on Chinese classification 171 CSP I 404 CSP II and 31 CSP III were identified Based on international classification 575 endogenous CSP and 31 exogenous CSP were identified The investigators compared the baseline data of two groups of subjects regarding fertility excluding cases with no fertility requirements or incomplete information Effectiveness was used to compare the resection surgery and conservative surgery in clinical practice Survival analysis was used to examine the relationship among post-surgical pregnancy interval and recurrent CSP The primary outcome was the effectiveness which included successful termination of the current CSP and non-CSP in the next pregnancy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None