Comparison of the Therapeutic Effects of Vaginal Repair With Leuprorelin and Vaginal Repair in the Treatment of Cesarean Section Scar Defect

Study Overview
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Brief Summary
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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
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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.

Official Title
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Comparison of the Therapeutic Effects of Vaginal Repair With Leuprorelin and Vaginal Repair in the Treatment of Cesarean Section Scar Defect

Conditions
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Cesarean Section; Dehiscence

Intervention / Treatment
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* Drug: Leuprorelin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vaginal Repair with Leuprorelin<br>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. | Drug: Leuprorelin<br>* Leuprorelin will be used to postpone period after vaginal repair.<br>|
| No Intervention: Vaginal Repair without Leuprorelin<br>The detailed procedure of Vaginal Repair has been described in our previous study. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| thickness of the remaining muscular layer (TRM) (mm) | The thickness of the remaining muscular layer is measured by magnetic resonance imaging (MRI) | 12 weeks after vaginal repair of CSD | 
| Duration of menstruation (day) | Duration of menstruation (day) | 12 weeks after vaginal repair of CSD | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cesarean Section Scar Defect, Zoladex, vaginal repair