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

NCT ID: NCT05206682

Last Updated: 2024-04-23

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 94 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-01
• Study Completion Date: 2026-04-30

Brief 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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Vaginal Repair with Leuprorelin

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.

Group Type: EXPERIMENTAL

Leuprorelin

Intervention Type: DRUG

Leuprorelin will be used to postpone period after vaginal repair.

Vaginal Repair without Leuprorelin

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Leuprorelin

Leuprorelin will be used to postpone period after vaginal repair.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Shanghai Jiaotong University xinhua hospital

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Wang Xipeng

Role: CONTACT

steveoizzie@icloud.com

+862125078999 ext. 6143

Facility Contacts

Xipeng Wang

Role: primary

13817806602

Other Identifiers

XH-21-013

Identifier Type: -

Identifier Source: org_study_id