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临床试验/NCT06485180
NCT06485180已完成不适用

Women's Hospital, Zhejiang University School of Medicine

Women's Hospital School Of Medicine Zhejiang University1 个研究点 分布在 1 个国家目标入组 606 人开始时间: 2019年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
606
试验地点
1
主要终点
effectiveness

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

The pregnancy outcomes and contraceptive methods were all reviewed through telephone follow-up. All outcomes Assessor were provided patients' name and telephone without surgery methods.

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • This retrospective study screened 1027 CSP individuals from the multiple center Medical Record Data System (MRDS) from three large hospitals in China, recorded between Jan 1, 2019, and Dec 31,
  • Conservative surgeries included dilatation and curettage (D&C) and hysteroscopy, and resection surgeries included CSP excision plus hysterotomy closure
  • Based on the widespread clinical utility of diagnostic criteria, four factors pertaining to patients, namely amenorrhea, clinical manifestations, laboratory results, and 3-D ultrasound or MRI findings, were thoroughly examined.
  • All participants were subsequently verified pathologically to confirm the presence of CSP.
  • Chinese CSP classification was selected as investigate group.
  • The international group encompasses endogenous and exogenous were selected as control group.

排除标准

  • those with incomplete medical record information or follow-up data;
  • those who did not undergo their first surgery at any of the three hospitals;
  • individuals without fertility requirements or have adopted long-term contraception were excluded;
  • who underwent surgery after December 31, 2022 were excluded, even if they became pregnant during the follow-up time.

结局指标

主要结局

effectiveness

时间窗: up to 3 years

The incidence rate of non-CSP

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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