DRUG
Leuprorelin
Leuprorelin will be used to postpone period after vaginal repair.
Comparison of the Therapeutic Effects of Vaginal Repair With Leuprorelin and Vaginal Repair in the Treatment of Cesarean Section Scar Defect
Status
Recruiting
Phase
Not applicable
Enrollment
94
Locations
1
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
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.
Full 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.
Interventions
Treatment arms and agents.
Timeline
From registration to results.
First posted
Jan 25, 2022
Study start
May 1, 2023
Primary completion
Apr 30, 2027
Study completion
Dec 30, 2027
Results posted
Not reported
Registry updated
Apr 24, 2026
Outcomes
What the study measures.
Primary outcomes
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)
Secondary outcomes
Not reported in the indexed record.
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- 50 Years
- Sex
- FEMALE
- Healthy volunteers
- No
Inclusion Criteria: 1. Clearly diagnosed with CSD complicated with adenomyosis 2. Experiencing clinical features of abnormal uterine bleeding, prolonged menstrual flow (the duration of menstruation is more than 10 days). 3. The thickness of the remaining muscular layer of CSD was less than 3 mm. 4. Normal range of blood sugar and insulin 5. No serious medical problems (important viscera function in the normal range). 6. uterine fibroids no more than 5cm 7. Sign the informed consent. Exclusion Criteria: 1. Indefinite diagnosis. 2. Malignant tumors. 3. With severe medical problems (severe liver disease, kidney disease, respiratory diseases, heart disease or uncontrolled diabetes, epilepsy, etc., dysfunction of important organs). 4. Pregnant. 5. Mental diseases. 6. Allergy to the any ingredients of Leuprorelin 7. Unwilling to comply with the research plan.
Study locations
1 registered sites.
China. Showing up to 24 locations stored in the fast local snapshot.
Shanghai Jiaotong University xinhua hospital
Shanghai, Shanghai Municipality, China
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
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