Actively Recruiting
Comparison of Vaginal Repair With Leuprorelin Versus Vaginal Repair Alone for Cesarean Section Scar Defect
Led by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine · Updated on 2026-04-24
94
Participants Needed
1
Research Sites
34 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the effects of vaginal repair surgery combined with Leuprorelin compared to vaginal repair alone in women diagnosed with Cesarean Section Scar Defect (CSD) complicated by adenomyosis. The study focuses on whether postponing the menstrual period after surgery can improve the healing and prognosis of the scar tissue. Women enrolled in the study will have abnormal uterine bleeding and prolonged menstrual flow related to their condition. Participants will undergo vaginal excision and suturing of the CSD. One group will receive subcutaneous injections of Leuprorelin three times over four weeks around the time of surgery to temporarily delay menstruation, which may reduce local inflammation and improve uterine conditions. The other group will receive vaginal repair without Leuprorelin. Both groups will be followed up to assess outcomes. During the study, participants will be examined at 6 months after surgery, with primary measures taken 12 weeks post-operation including the thickness of the remaining muscular layer at the scar site and the duration of menstruation. Researchers will monitor healing and changes in uterine tissue to assess the impact of the delayed period treatment. The study is randomized and open-label, with participation lasting from surgery to follow-up assessments.
CONDITIONS
Brief Title
Comparison of the Therapeutic Effects of Vaginal Repair With Leuprorelin and Vaginal Repair in the Treatment of Cesarean Section Scar Defect
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Clearly diagnosed with Cesarean Section Scar Defect complicated with adenomyosis
- Experiencing abnormal uterine bleeding with prolonged menstrual flow lasting more than 10 days
- Thickness of the remaining muscular layer of the scar is less than 3 mm
- Blood sugar and insulin levels within normal range
- No serious medical problems with important organ functions normal
- Uterine fibroids no larger than 5 cm
- Signed informed consent to participate
You will not qualify if you...
- Unclear or indefinite diagnosis
- Presence of malignant tumors
- Severe medical problems such as severe liver, kidney, respiratory, heart diseases, uncontrolled diabetes, epilepsy, or organ dysfunction
- Currently pregnant
- Mental health disorders
- Allergy to any ingredients of Leuprorelin
- Unwillingness to comply with the study plan
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo vaginal excision and suture of the Cesarean Section Scar Defect.
1 surgical visit (in-person)
Duration - 4 weeks
Participants receive vaginal repair with or without Leuprorelin injections to improve healing of the scar.
3 Leuprorelin injections over 4 weeks (in the experimental group)
Duration - 6 months
Participants are assessed 6 months after surgery to evaluate the healing and condition of the scar.
1 follow-up visit (in-person)
Trial Site Locations
Total: 1 location
1
Shanghai Jiaotong University xinhua hospital
Shanghai, Shanghai Municipality, China, 200092
Actively Recruiting
Research Team
W
Wang Xipeng
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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