Uterine Caesarean Scar DefectNCT07169435
Enhanced Reproductive Efficiency: Shorter Time to Pregnancy After Hysteroscopic-Assisted Novel Transvaginal Repair
An observational study of Uterine Caesarean Scar Defect, run by International Peace Maternity and Child Health Hospital at 1 site in China.
Trial summary
To investigate whether a novel hysteroscopic-assisted transvaginal repair technique results in a shorter time to pregnancy and superior fertility outcomes compared to traditional transvaginal repair. Read more about this study
- Who is it for?
- Ages 18 to 48 years, women only
- Conditions the study is for
- Uterine Caesarean Scar Defect
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2019to 30 Apr 2023
- 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 18 to 48 years
- Women only
- Adult
Study population: This prospective cohort study was conducted between May 2019 and May 2023 at Department of Gynecology and Obstetrics, International Peace Maternity and Child Health Hospital (IPMCH), Jiao Tong University School of Medicine, Shanghai, China.
Who may be able to join
- Patients with a large niche (defined as niche with a depth of >50% of the myometrial thickness and a residual myometrial thickness (RMT) ≤3mm) Patients have fertility requirements Patients were aged between 18 and 48 years Patients who requested transvaginal surgery (the final decision about operation method was made by the patient (shared decision making))
Who cannot join
- Patients with a narrow vaginal canal or any evidence of severe pelvic adhesion around the uterus Patients with post-operative biopsy-proven atypical endometrial hyperplasia and endometrial cancer
Trial locations and contacts
1 site in 1 country.
China1 site
International Peace Maternity and Child Health Hospital
Shanghai, Shanghai Municipality, 200030
About this study
To investigate whether a novel hysteroscopic-assisted transvaginal repair technique results in a shorter time to pregnancy and superior fertility outcomes compared to traditional transvaginal repair.
- Conditions
- Uterine Caesarean Scar Defect
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Hysteroscopic-assisted novel transvaginal repair | Traditional transvaginal repair (TTR) procedure mainly involves two steps: the obvious scar-like defect excision and the full-thickness myometrial closure, which maybe form a new scar defect due to the uncertain scar healing process. | |
| Traditional transvaginal repair | Hysteroscopic-assisted novel transvaginal repair (NTR) surgery does not need to remove the original scar defect. Instead, suture was used to interruptedly suture the myometrium at the upper and lower margins of the scar to close the niche or reduce its size, which retains the integrity of the myometrium. |
What is being measured
The primary outcome is the main question the study is designed to answer.
the median time to pregnancy following surgery
It is the time point at which half of the patients in the study who attempted to conceive after surgery had successfully become pregnant, and the other half had not
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2025
- Study start1 May 2019
- Primary completion30 Apr 2023
- Study completion30 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine Caesarean Scar DefectStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Peace Maternity and Child Health Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07169435
- Sponsor's protocol ID
- (GKLW)2018-23
- Status last verified
- Aug 2025
- First submitted
- 4 Sep 2025
- Last updated
- 16 Sep 2025
- 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 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhanced Reproductive Efficiency: Shorter Time to Pregnancy After Hysteroscopic-Assisted Novel Transvaginal Repair
- ClinicalTrials.gov ID
- NCT07169435
- Acronym / sponsor ID
- (GKLW)2018-23
- Conditions
- Uterine Caesarean Scar Defect
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- International Peace Maternity and Child Health HospitalUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 30 Apr 2023 (actual)
- Study completion
- 30 Apr 2023 (actual)
- First posted
- 11 Sep 2025 (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.
To investigate whether a novel hysteroscopic-assisted transvaginal repair technique results in a shorter time to pregnancy and superior fertility outcomes compared to traditional transvaginal repair.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hysteroscopic-assisted novel transvaginal repair | – | –Traditional transvaginal repair (TTR) procedure mainly involves two steps: the obvious scar-like defect excision and the full-thickness myometrial closure, which maybe form a new scar defect due to the uncertain scar healing process. |
| Traditional transvaginal repair | – | –Hysteroscopic-assisted novel transvaginal repair (NTR) surgery does not need to remove the original scar defect. Instead, suture was used to interruptedly suture the myometrium at the upper and lower margins of the scar to close the niche or reduce its size, which retains the integrity of the myometrium. |
Who may qualify
- Ages
- 18 to 48 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- This prospective cohort study was conducted between May 2019 and May 2023 at Department of Gynecology and Obstetrics, International Peace Maternity and Child Health Hospital (IPMCH), Jiao Tong University School of Medicine, Shanghai, China.
Key inclusion criteria (1 listed)
- Patients with a large niche (defined as niche with a depth of >50% of the myometrial thickness and a residual myometrial thickness (RMT) ≤3mm) Patients have fertility requirements Patients were aged between 18 and 48 years Patients who requested transvaginal surgery (the final decision about operation method was made by the patient (shared decision making))
Key exclusion criteria (1 listed)
- Patients with a narrow vaginal canal or any evidence of severe pelvic adhesion around the uterus Patients with post-operative biopsy-proven atypical endometrial hyperplasia and endometrial cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
the median time to pregnancy following surgery
Time frame: 2 years
It is the time point at which half of the patients in the study who attempted to conceive after surgery had successfully become pregnant, and the other half had not
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 16 Sep 2025.
- Individual participant dataSharing planned: No
Related trials for Uterine Caesarean Scar Defect
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Effectiveness of Transvaginal Niche Resection Versus Expectant Management in Patients with Secondary Infertility and a Large Uterine Caesarean Scar Defect
Caesarean Scar Defect
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Uterine Caesarean Scar Defect, run by International Peace Maternity and Child Health Hospital 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 1 inclusion and 1 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 16 Sep 2025. 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?
the median time to pregnancy following surgery (time frame: 2 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 16 Sep 2025.