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

NCT06485180 | Completed DMC

• 1 other identifier: PR02024-069
• Study Type: interventional
• Target: 606
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy Complications

Outcome Measures

Primary Outcomes (1)

• effectiveness

  The incidence rate of non-CSP

  up to 3 years

Study Arms (2)

Conservative surgery

ACTIVE COMPARATOR

D\&C: A curette is inserted into the uterus through the dilated cervix. The curette is used to scrape the lining of the uterus and remove the pregnancy tissue. Hysteroscopy: The procedure can be used for CSP with progression toward the uterine cavity or the bladder. The gestational sac is dissected free of the uterine wall through a natural entrance, and hemostasis can be achieved with electro-coagulation using a wire-loop or roller-ball. Hysteroscopy is a minimally invasive technique and is conducted under direct observation or combined with abdominal ultrasound.

Procedure: Active comparator

Resection surgery

ACTIVE COMPARATOR

Transvaginal CSP excision: The bladder is dissected away through an incision in the anterior cervico-vaginal junction, and the CSP is identified in the anterior part of the lower uterine segment. The ectopic pregnancy tissue is removed through a transverse incision, and suction curettage through the incision on the uterus can be performed. Finally, the myometrial and vaginal defects are repaired. Hysteroscopy-assisted laparoscopic CSP excision: Under the guidance of the light of hysteroscopy, position CSP accurately and excision is performed of the uterine scar that contains the ectopic pregnancy, with subsequent repair of the defect in the uterus. After laparoscopic CSP excision, hysteroscopy proved that the niche had disappeared. Abdominal CSP excision: The ectopic pregnancy tissue is removed through an abdominal incision, and suction curettage through the incision on the uterus can be performed. Finally, the myometrial and abdominal defects are repaired.

Procedure: Active comparator

Interventions

Active comparator PROCEDURE

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.

Conservative surgery; Resection surgery

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Cesarean scar pregnancy can happened to female only.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Women's Hospital School Of Medicine Zhejiang University: lead
• Peking University: collaborator

Study Sites (1)

Women's hospital, school of medicine, zhejiang university

Hangzhou, Zhejiang, 310006, China

Location

MeSH Terms

Conditions

Pregnancy Complications

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Xiuxiu Jiang

  Women's Hospital School Of Medicine Zhejiang University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 21, 2024
• First Posted: July 3, 2024
• Study Start: January 1, 2019
• Primary Completion: December 31, 2022
• Study Completion: June 1, 2024
• Last Updated: July 10, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)