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

Shanghai Jiao Tong University

Status: Enrolling

Conditions: Cesarean Section; Dehiscence

Treatments: Drug: Leuprorelin

Study type: Interventional

Funder types: Other

Identifiers

NCT05206682

XH-21-013

Details and patient eligibility

About

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 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.

Enrollment: 94 estimated patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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94 participants in 2 patient groups

Vaginal Repair with Leuprorelin

Experimental group

Description:

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.

Treatment:

Drug: Leuprorelin

Vaginal Repair without Leuprorelin

No Intervention group

Description:

The detailed procedure of Vaginal Repair has been described in our previous study.