Pregnancy ComplicationsCECSNCT06485180
Comparative Effectiveness of Uterine Repair Surgery on Preventing Recurrence of Cesarean Sar Pregnancy
A study testing Active comparator in people with Pregnancy Complications, run by Women's Hospital School Of Medicine Zhejiang University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Pregnancy Complications
- What is being tested?
- Active comparator
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 606 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2019to 1 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Women's hospital, school of medicine, zhejiang university
Hangzhou, Zhejiang, 310006
About this study
Official title: Women's Hospital, Zhejiang University School of Medicine
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.
Read the 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
- Being tested
- Active comparator
- Medical subject headings
- Pregnancy Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active comparatorProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Active comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
effectiveness
The incidence rate of non-CSP
Measured: up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start1 Jan 2019
- Primary completion31 Dec 2022
- Study completion1 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 606 participants (actual)
Sponsor and investigators
- Lead sponsor
- Women's Hospital School Of Medicine Zhejiang University
- Sponsor type
- University, hospital or other
- Collaborators
- Peking University
- Responsible party
- Sponsor
- Investigators
- Xiuxiu Jiang, Principal investigator, Women's Hospital School Of Medicine Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06485180
- Sponsor's protocol ID
- PR02024-069
- Acronym
- CECS
- Status last verified
- Jun 2024
- First submitted
- 21 Jun 2024
- Last updated
- 10 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Women's Hospital, Zhejiang University School of Medicine
- ClinicalTrials.gov ID
- NCT06485180
- Acronym / sponsor ID
- CECS / PR02024-069
- Conditions
- Pregnancy Complications
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 606 participants (actual)
- Lead sponsor
- Women's Hospital School Of Medicine Zhejiang UniversityUniversity, hospital or other
- Collaborators
- Peking University
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 3 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Conservative surgery | Active comparator | Procedure: Active comparatorD\&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. |
| Resection surgery | Active comparator | Procedure: Active comparatorTransvaginal 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active comparatorParticipants 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. | Procedure or surgery | Conservative surgery, Resection surgery |
Primary outcome
effectiveness
Time frame: up to 3 years
The incidence rate of non-CSP
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiuxiu Jiang principal investigator
Women's Hospital School Of Medicine Zhejiang University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active comparator in people with Pregnancy Complications, run by Women's Hospital School Of Medicine Zhejiang University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
effectiveness (time frame: up to 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2024.