Cesarean Section; DehiscenceNCT05206682
Comparison of the Therapeutic Effects of Vaginal Repair With Leuprorelin and Vaginal Repair in the Treatment of Cesarean Section Scar Defect
A study testing Leuprorelin in people with Cesarean Section; Dehiscence, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
GnRH-a will be used to postpone period after vaginal repair for Cesarean Section Scar Defect（CSD） patients with adenomyosis which will be compared with CSD patients with adenomyosis who receive transvaginal surgery without GnRH-a, whether delayed period improving the CSD prognosis will be assessed. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Cesarean Section; Dehiscence
- What is being tested?
- Leuprorelin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2023to 30 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Clearly diagnosed with CSD complicated with adenomyosis
- Experiencing clinical features of abnormal uterine bleeding, prolonged menstrual flow (the duration of menstruation is more than 10 days).
- The thickness of the remaining muscular layer of CSD was less than 3 mm.
- Normal range of blood sugar and insulin
- No serious medical problems (important viscera function in the normal range).
- uterine fibroids no more than 5cm
- Sign the informed consent.
Who cannot join
- Indefinite diagnosis.
- Malignant tumors.
- With severe medical problems (severe liver disease, kidney disease, respiratory diseases, heart disease or uncontrolled diabetes, epilepsy, etc., dysfunction of important organs).
- Pregnant.
- Mental diseases.
- Allergy to the any ingredients of Leuprorelin
- Unwilling to comply with the research plan.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai Jiaotong University xinhua hospital
Shanghai, Shanghai Municipality, 200092
Xipeng Wang, 13817806602
About this study
GnRH-a will be used to postpone period after vaginal repair for Cesarean Section Scar Defect（CSD） patients with adenomyosis which will be compared with CSD patients with adenomyosis who receive transvaginal surgery without GnRH-a, whether delayed period improving the CSD prognosis will be assessed.
Read the detailed description
Women with CSD complicated with adenomyosis will be enrolled in this study. They all will receive vaginal excision and suture of CSD and will be required to undergo examinations at 6-months after surgery.
Interventioned group will be subcutaneous injected of Leuprorelin to postpone period after vaginal repair. It is be assumed that temporary menopause could improve inner conditions of uterus, there would be less local inflammation reaction which would be beneficial to the scar healed.
- Conditions
- Cesarean Section; Dehiscence
- Being tested
- Leuprorelin
- Keywords
- Cesarean Section Scar Defect, Zoladex, vaginal repair
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LeuprorelinDrug
Leuprorelin will be used to postpone period after vaginal repair.
| Study group | Role | What they receive |
|---|---|---|
| Vaginal Repair with Leuprorelin | Experimental | CSD patients were treated with vaginal repair of CSD in combination with Leuprorelin . In the group of Vaginal Repair With Leuprorelin, the patients will get 3 times of Leuprorelin per 4 weeks perioperation. The detailed procedure of Vaginal Repair has been described in our previous study. Receives: Drug: Leuprorelin |
| Vaginal Repair without Leuprorelin | No intervention | The detailed procedure of Vaginal Repair has been described in our previous study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
thickness of the remaining muscular layer (TRM) (mm)
The thickness of the remaining muscular layer is measured by magnetic resonance imaging (MRI)
Measured: 12 weeks after vaginal repair of CSD
Duration of menstruation (day)
Duration of menstruation (day)
Measured: 12 weeks after vaginal repair of CSD
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2022
- Study start1 May 2023
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean Section; DehiscenceStudies of the same condition, open and under way.
- More trials run by Xinhua Hospital, Shanghai Jiao Tong University School of MedicineThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 94 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05206682
- Sponsor's protocol ID
- XH-21-013
- Status last verified
- Apr 2026
- First submitted
- 11 Jan 2022
- Last updated
- 24 Apr 2026
- Results posted
- No
- 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 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Therapeutic Effects of Vaginal Repair With Leuprorelin and Vaginal Repair in the Treatment of Cesarean Section Scar Defect
- ClinicalTrials.gov ID
- NCT05206682
- Acronym / sponsor ID
- XH-21-013
- Conditions
- Cesarean Section; Dehiscence
- Keywords
- Cesarean Section Scar Defect, Zoladex, vaginal repair
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 94 participants (estimated)
- Lead sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 25 Jan 2022 (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.
GnRH-a will be used to postpone period after vaginal repair for Cesarean Section Scar Defect（CSD） patients with adenomyosis which will be compared with CSD patients with adenomyosis who receive transvaginal surgery without GnRH-a, whether delayed period improving the CSD prognosis will be assessed.
Detailed description
Women with CSD complicated with adenomyosis will be enrolled in this study. They all will receive vaginal excision and suture of CSD and will be required to undergo examinations at 6-months after surgery.
Interventioned group will be subcutaneous injected of Leuprorelin to postpone period after vaginal repair. It is be assumed that temporary menopause could improve inner conditions of uterus, there would be less local inflammation reaction which would be beneficial to the scar healed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vaginal Repair with Leuprorelin | Experimental | Drug: LeuprorelinCSD patients were treated with vaginal repair of CSD in combination with Leuprorelin . In the group of Vaginal Repair With Leuprorelin, the patients will get 3 times of Leuprorelin per 4 weeks perioperation. The detailed procedure of Vaginal Repair has been described in our previous study. |
| Vaginal Repair without Leuprorelin | No intervention | –The detailed procedure of Vaginal Repair has been described in our previous study. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Clearly diagnosed with CSD complicated with adenomyosis
- Experiencing clinical features of abnormal uterine bleeding, prolonged menstrual flow (the duration of menstruation is more than 10 days).
- The thickness of the remaining muscular layer of CSD was less than 3 mm.
- Normal range of blood sugar and insulin
- No serious medical problems (important viscera function in the normal range).
Key exclusion criteria (7 listed)
- Indefinite diagnosis.
- Malignant tumors.
- With severe medical problems (severe liver disease, kidney disease, respiratory diseases, heart disease or uncontrolled diabetes, epilepsy, etc., dysfunction of important organs).
- Pregnant.
- Mental diseases.
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 |
|---|---|---|
| LeuprorelinLeuprorelin will be used to postpone period after vaginal repair. | Drug | Vaginal Repair with Leuprorelin |
Primary outcome
thickness of the remaining muscular layer (TRM) (mm)
Time frame: 12 weeks after vaginal repair of CSD
The thickness of the remaining muscular layer is measured by magnetic resonance imaging (MRI)
Duration of menstruation (day)
Time frame: 12 weeks after vaginal repair of CSD
Duration of menstruation (day)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Leuprorelin in people with Cesarean Section; Dehiscence, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine 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 7 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 24 Apr 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wang Xipeng (+862125078999 ext. 6143, steveoizzie@icloud.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
thickness of the remaining muscular layer (TRM) (mm) (time frame: 12 weeks after vaginal repair of CSD). 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 24 Apr 2026.