NCT06485180

Comparative Effectiveness of Uterine Repair Surgery on Preventing Recurrence of Cesarean Sar Pregnancy

Women's Hospital, Zhejiang University School of Medicine

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 606 (actual)
• Sponsor: Women's Hospital School Of Medicine Zhejiang University · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

The goal of this observational study is to learn about the long-term effects of resection surgery which is cesarean scar pregnancy(CSP) 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.

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.

Conditions

• Pregnancy Complications

Interventions

Type	Name	Description
PROCEDURE	Active comparator	Participants from conservative group were selected as uterine curettage (D\&C) cohort , hysteroscopy cohort, Uterine Artery Embolization (UAE) in Combination with D\&C, without MTX cohort, UAE in Combination D\&C with MTX cohort and UAE+ D\&C+hysteroscopy. Participants from CSP excision plus hysterotomy closure group were selected as transvaginal CSP excision cohort, hysteroscopy-assisted laparoscopic CSP excision cohort and abdominal CSP excision cohort.

Timeline

• Start date: 2019-01-01
• Primary completion: 2022-12-31
• Completion: 2024-06-01
• First posted: 2024-07-03
• Last updated: 2024-07-10

Locations

1 site across 1 country: China