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

Cesarean Section; Dehiscence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05206682
• Other study ID #: XH-21-013
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2023
• Est. completion date: April 30, 2026

Study information

• Verified date: February 2024
• Source: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
• Contact: Wang Xipeng
• Phone: +862125078999
• Email: steveoizzie[@]icloud.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 94
• Est. completion date: April 30, 2026
• Est. primary completion date: April 30, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cesarean Section; Dehiscence

Intervention

Drug:
• Leuprorelin
Leuprorelin will be used to postpone period after vaginal repair.

Locations

Country	Name	City	State
China	Shanghai Jiaotong University xinhua hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Duration of menstruation (day)	Duration of menstruation (day)	12 weeks after vaginal repair of CSD