An interventional study of Active comparator in Pregnancy Complications, sponsored by Women's Hospital School Of Medicine Zhejiang University. Completed at 1 site in China. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2024-07-10.
Sponsored by Women's Hospital School Of Medicine Zhejiang University · Not applicable, Interventional, and Treatment
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.
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.
437 studies on the registry are indexed under Pregnancy Complications; 119 are open to participants now.
This study's enrollment of 606 is above the median of 147 across 220 interventional studies indexed under Pregnancy Complications.
Browse Pregnancy Complications studies →Women's Hospital School Of Medicine Zhejiang University is the lead sponsor of 74 studies on the registry; 44 are open to participants now.
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Exclusion Criteria:
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
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
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.
effectiveness
The incidence rate of non-CSP
Time frame: up to 3 years
Plan to share: No
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This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
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Women's Hospital School Of Medicine Zhejiang University