Clinical trial NCT06485180: Comparative Effectiveness of Uterine Repair Surgery on Preventing Recurrence of Cesarean Sar Pregnancy
Official title: Women's Hospital, Zhejiang University School of Medicine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy Complications
Lead sponsor: Women's Hospital School Of Medicine Zhejiang University
Sponsor class: OTHER
Collaborators: name: Peking University
First posted: 2024-07-03
Enrollment: 606
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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, 2022. 606 patients underwent surgical treatment. The pregnancy outcomes and contraceptive methods were all reviewed through telephone follow-up. Conservative surgeries included dilatation and curettage (D\&C) and hysteroscopy and resection surgeries included CSP excision plus hysterotomy closure.
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

1. 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, 2022.
2. Conservative surgeries included dilatation and curettage (D\&C) and hysteroscopy, and resection surgeries included CSP excision plus hysterotomy closure
3. 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.
4. All participants were subsequently verified pathologically to confirm the presence of CSP.
5. Chinese CSP classification was selected as investigate group.
6. The international group encompasses endogenous and exogenous were selected as control group.

Exclusion Criteria:

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

Primary outcomes:
measure: effectiveness
timeFrame: up to 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Women's hospital, school of medicine, zhejiang university
state: Zhejiang
Study officials:
affiliation: Women's Hospital School Of Medicine Zhejiang University
name: Xiuxiu Jiang
role: PRINCIPAL_INVESTIGATOR
References: