- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07608094
The Treatment Outcomes of Cesarean Scar Pregnancy
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The excisional surgeries were conducted via excision of the cesarean scar pregnancy and closure of the uterine incision through a transvaginal approach or hysteroscopy-assisted laparoscopic approach.
Conservative surgeries refer to the removal of intrauterine pregnancy tissues through ultrasound-guided vacuum aspiration or hysteroscopic surgery.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: xiuxiu jiang, ph.D
- Phone Number: 0086-571-87061501
- Email: jaingxiuxiu0418@zju.edu.cn
Study Locations
-
-
Zhejiang
-
Hangzhou, Zhejiang, China, 310006
- Recruiting
- Women's Hospital School of Medicine Zhejiang University
-
Contact:
- Xiuxiu Jiang, Ph.D
- Phone Number: +8613588709941
- Email: jiangxiuxiu0418@zju.edu.cn
-
Sub-Investigator:
- Wanren Zheng, MD
-
Sub-Investigator:
- Juan Yu, MD
-
Sub-Investigator:
- Meijun Guo, MD
-
Sub-Investigator:
- Ning Wang, MD
-
Sub-Investigator:
- Shanshan Ni, MD
-
Sub-Investigator:
- Xingmiao Li, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
A prospective randomized controlled study evaluating the impact of various treatment modalities for cesarean scar pregnancy on treatment outcomes and pregnancy outcomes. The excisional surgeries were conducted via excision of the cesarean scar pregnancy and closure of the uterine incision through a transvaginal approach or hysteroscopy-assisted laparoscopic approach.
Conservative surgeries refer to the removal of intrauterine pregnancy tissues through ultrasound-guided vacuum aspiration or hysteroscopic surgery.
Description
Inclusion Criteria:
- Women over 18 years old with a history of cesarean section
- Ultrasound diagnosis of cesarean scar pregnancy
- No severe internal or external diseases, such as liver disease, kidney disease, cardiovascular disease, cerebrovascular disease, etc., and able to tolerate surgery
Exclusion Criteria:
- Women under the age of 18
- CSP patients who have received treatment in other hospitals
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
excisional surgery group
The excisional surgeries were conducted via excision of the cesarean scar pregnancy and closure of the uterine incision through a transvaginal approach or hysteroscopy-assisted laparoscopic approach.
|
The excisional surgeries were conducted via excision of the cesarean scar pregnancy and closure of the uterine incision through a transvaginal approach or hysteroscopy-assisted laparoscopic approach.
Conservative surgeries refer to the removal of intrauterine pregnancy tissues through ultrasound-guided vacuum aspiration or hysteroscopic surgery.
|
|
conservative surgery group
Conservative surgeries refer to the removal of intrauterine pregnancy tissues through ultrasound-guided vacuum aspiration or hysteroscopic surgery.
|
The excisional surgeries were conducted via excision of the cesarean scar pregnancy and closure of the uterine incision through a transvaginal approach or hysteroscopy-assisted laparoscopic approach.
Conservative surgeries refer to the removal of intrauterine pregnancy tissues through ultrasound-guided vacuum aspiration or hysteroscopic surgery.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
successful surgical treatment
Time Frame: One day after surgery
|
successful treatment rate after surgery
|
One day after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
complication
Time Frame: One day after surgery
|
severe complication rate after surgery
|
One day after surgery
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
subsequent pregnancy rate
Time Frame: Up to 24 months after surgery without contraception and the time since the last menstrual period is 4 weeks or more.
|
subsequent pregnancy rate after surgery
|
Up to 24 months after surgery without contraception and the time since the last menstrual period is 4 weeks or more.
|
|
CSP recurrence rate
Time Frame: Up to 24 months after surgery without contraception
|
CSP recurrence rate after surgery
|
Up to 24 months after surgery without contraception
|
|
pregnancy interval
Time Frame: Up to 24 months (the time interval between the cessation of contraception after surgery and the time of last menstrual period of the subsequent pregnancy)
|
pregnancy interval after surgery
|
Up to 24 months (the time interval between the cessation of contraception after surgery and the time of last menstrual period of the subsequent pregnancy)
|
Collaborators and Investigators
Investigators
- Principal Investigator: xiuxiu jiang, women's hospital school of medicine Zhejiang uni
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- XiuxiuJiang
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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