Post Cesarean Scar DefectNCT04096677
Effects of Hysteroscopy and Transvaginal Surgery on Reproductive Prognosis in Patients With Post Cesarean Scar Defect
An observational study of Post Cesarean Scar Defect and Hysteroscopy, run by First Affiliated Hospital, Sun Yat-Sen University at 2 sites in China.
Trial summary
The study is to compare hysteroscopic repair and transvaginal intervention for correcting uterine defect in patients with post cesarean scar defect (PCSD) and the reproductive prognosis. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Post Cesarean Scar Defect, Hysteroscopy
- What is being tested?
- hysteroscpy
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 2 sitesChina
- Study dates
- 1 Jan 2017to 30 Oct 2019
- How long will I take part?
- 2 Years
- Phase
- Observational
- 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 20 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: patients who received hysteroscopy in the Department of Obstetrics and Gynecology of the First Affiliated Hospital of Sun Yat-sen University and were diagnosed with post cesarean scar defect according to the transvaginal ultrasonography or hysteroscopy were recruited into present study.
Who may be able to join
- Patients had a history of transverse lower uterine segment cesarean section;
- Patients had a previous regular menstruation, while after caesarean section, they occurred prolonged postmentrual bleeding (10-20days)
- Medication failed(contraceptive pills).
- Sex hormone test is normal;
- TVU or hysteroscopy showed a triangular or U-shaped anechoic liquid dark area and on the anterior lower uterine segment in relation to cesarean section scar during menstruation of 7-12 days or hysteroscopic examination showed uterine anterior wall defect like dome changes at isthmus below internal orifice of cervix.
Who cannot join
- Irregular menstrual cycle before cesarean section
- Previous placement of an intrauterine contraceptive device
- Presence of other organic uterine pathology responsible for abnormal uterine bleeding, such as endometrial hyperplasia, polyps or submucosal myomas, cervical cancer, endometrial cancer, etc
- Existence of endocrine diseases, such as dysfunction of pituitary, ovarian, adrenal gland, and thyroid;
- Coagulation dysfunction.
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
First affiliated hospital of SUN Yat-Sen University
Guangzhou, Guangdong, 510000
Yuqing Chen, MD
- Recruiting
The First Affiliated Hospital of SunYetSen University
Guangzhou, Guangdong, 510000
Yuqing Chen, MD, 13724067575, fangchenyq@163.com
About this study
Official title: Effects of Hysteroscopy and Transvaginal Surgery on Reproductive Prognosis and Endometrium Receptive in Patients With Post Cesarean Scar Defect
The study is to compare hysteroscopic repair and transvaginal intervention for correcting uterine defect in patients with post cesarean scar defect (PCSD) and the reproductive prognosis.
Read the detailed description
Post cesarean scar defect (PCSD), refers the lower uterine segment form a reservoir-like pouch during healing process after transverse lower uterine segment cesarean section connected with uterine cavity. The pouch has a valve-like effect, obstructing blood drainage and accumulating blood in depression. These causes may lead to a variety of gynecological disturbances, secondary dysmenorrheal and infertility. Some patients can occur some serious obstetric complications, such as cesarean scar pregnancy and even the rupture of uterus during a subsequent pregnancy. At present, the causes and mechanisms of PCSD are not clear, diagnosis and treatment are not uniform. Surgical methods include abdominal surgery, laparoscopic surgery, transvaginal surgery, hysteroscopic surgery, hysteroscopic with laparoscopic surgery and so on. Hysteroscopic and transvaginal surgery to treating PCSD both are minimally invasive and feasible surgical approach. However, hysteroscopic surgery and transvaginal surgery have not been compared for correcting the uterine defect in patients with PCSD before.
- Conditions
- Post Cesarean Scar Defect, Hysteroscopy
- Being tested
- hysteroscpy
- Keywords
- post cesarean scar defect, hysteroscopy, transvaginal intervention, endometrial receptive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hysteroscpyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| hysteroscopy repair | patients with post cesarean scar defect Receives: Procedure: hysteroscpy | |
| transvaginal repair | patients with post cesarean scar defect |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with a less postoperative menstruation
Follow-up carried out 6 months after the initial operation, using the following criteria to evaluate curative effect: Cure: menstrual duration was shortened to no more than 7 days and TVU showed no liquid dark area in scar of lower uterine segment; Improvement: menstrual duration was reduced by more than 2 days, but menstrual duration was still longer than 7days and TVU showed the liquid dark area in lower segment of uterus disappeared or narrowed. Failure: menstrual duration was reduced by less than 2 days or had no obvious change, and TVU showed the liquid dark area in lower segment of uterus did not narrow. Efficiency rate = cure rate + improvement rate.
Measured: 6 months
Number of Participants being a pregnant
Follow-up carried out 1 year after the initial operation, postoperative pregnancy with a history of infertility preoperatively
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2019
- Study start1 Jan 2017
- Primary completion30 Sep 2019 (estimated)
- Study completion30 Oct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Cesarean Scar DefectStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital, Sun Yat-Sen UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yuqing Chen, First Affiliated Hospital, Sun Yat-Sen University
- Investigators
- Yuqing Chen, Study chair, The First Affiliated Hospital of SunYetSen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04096677
- Sponsor's protocol ID
- Post cesarean scar defect
- Status last verified
- Sep 2019
- First submitted
- 18 Sep 2019
- Last updated
- 20 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Hysteroscopy and Transvaginal Surgery on Reproductive Prognosis and Endometrium Receptive in Patients With Post Cesarean Scar Defect
- ClinicalTrials.gov ID
- NCT04096677
- Acronym / sponsor ID
- Post cesarean scar defect
- Conditions
- Post Cesarean Scar Defect, Hysteroscopy
- Keywords
- post cesarean scar defect, hysteroscopy, transvaginal intervention, endometrial receptive
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- First Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 30 Sep 2019 (estimated)
- Study completion
- 30 Oct 2019 (estimated)
- First posted
- 20 Sep 2019 (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 study is to compare hysteroscopic repair and transvaginal intervention for correcting uterine defect in patients with post cesarean scar defect (PCSD) and the reproductive prognosis.
Detailed description
Post cesarean scar defect (PCSD), refers the lower uterine segment form a reservoir-like pouch during healing process after transverse lower uterine segment cesarean section connected with uterine cavity. The pouch has a valve-like effect, obstructing blood drainage and accumulating blood in depression. These causes may lead to a variety of gynecological disturbances, secondary dysmenorrheal and infertility. Some patients can occur some serious obstetric complications, such as cesarean scar pregnancy and even the rupture of uterus during a subsequent pregnancy. At present, the causes and mechanisms of PCSD are not clear, diagnosis and treatment are not uniform. Surgical methods include abdominal surgery, laparoscopic surgery, transvaginal surgery, hysteroscopic surgery, hysteroscopic with laparoscopic surgery and so on. Hysteroscopic and transvaginal surgery to treating PCSD both are minimally invasive and feasible surgical approach. However, hysteroscopic surgery and transvaginal surgery have not been compared for correcting the uterine defect in patients with PCSD before.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hysteroscopy repair | – | Procedure: hysteroscpypatients with post cesarean scar defect |
| transvaginal repair | – | –patients with post cesarean scar defect |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- patients who received hysteroscopy in the Department of Obstetrics and Gynecology of the First Affiliated Hospital of Sun Yat-sen University and were diagnosed with post cesarean scar defect according to the transvaginal ultrasonography or hysteroscopy were recruited into present study.
Key inclusion criteria (5 listed)
- Patients had a history of transverse lower uterine segment cesarean section;
- Patients had a previous regular menstruation, while after caesarean section, they occurred prolonged postmentrual bleeding (10-20days)
- Medication failed(contraceptive pills).
- Sex hormone test is normal;
- TVU or hysteroscopy showed a triangular or U-shaped anechoic liquid dark area and on the anterior lower uterine segment in relation to cesarean section scar during menstruation of 7-12 days or hysteroscopic examination showed uterine anterior wall defect like dome changes at isthmus below internal orifice of cervix.
Key exclusion criteria (5 listed)
- Irregular menstrual cycle before cesarean section
- Previous placement of an intrauterine contraceptive device
- Presence of other organic uterine pathology responsible for abnormal uterine bleeding, such as endometrial hyperplasia, polyps or submucosal myomas, cervical cancer, endometrial cancer, etc
- Existence of endocrine diseases, such as dysfunction of pituitary, ovarian, adrenal gland, and thyroid;
- Coagulation dysfunction.
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 |
|---|---|---|
| hysteroscpy | Procedure or surgery | hysteroscopy repair |
Primary outcome
Number of Participants with a less postoperative menstruation
Time frame: 6 months
Follow-up carried out 6 months after the initial operation, using the following criteria to evaluate curative effect: Cure: menstrual duration was shortened to no more than 7 days and TVU showed no liquid dark area in scar of lower uterine segment; Improvement: menstrual duration was reduced by more than 2 days, but menstrual duration was still longer than 7days and TVU showed the liquid dark area in lower segment of uterus disappeared or narrowed. Failure: menstrual duration was reduced by less than 2 days or had no obvious change, and TVU showed the liquid dark area in lower segment of uterus did not narrow. Efficiency rate = cure rate + improvement rate.
Number of Participants being a pregnant
Time frame: 1 year
Follow-up carried out 1 year after the initial operation, postoperative pregnancy with a history of infertility preoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2019.
- Individual participant dataSharing planned: Yes
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.
Yuqing Chen study chair
The First Affiliated Hospital of SunYetSen University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post Cesarean Scar Defect and Hysteroscopy, run by First Affiliated Hospital, Sun Yat-Sen University at 2 sites 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 5 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 20 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yuqing Chen, MD (13724067575, fangchenyq@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with a less postoperative menstruation (time frame: 6 months). The study lists 2 primary outcomes in all. 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 20 Sep 2019.