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

NCT05206682 | Recruiting

• 1 other identifier: XH-21-013
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

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.

Conditions

Cesarean Section; Dehiscence

Keywords

Cesarean Section Scar Defect; Zoladex; vaginal repair

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Vaginal Repair with Leuprorelin

EXPERIMENTAL

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

Vaginal Repair without Leuprorelin

NO INTERVENTION

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

Interventions

Leuprorelin DRUG

Leuprorelin will be used to postpone period after vaginal repair.

Vaginal Repair with Leuprorelin

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xinhua Hospital, Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

Shanghai Jiaotong University xinhua hospital

Shanghai, Shanghai Municipality, 200092, China

RECRUITING

MeSH Terms

Interventions

Leuprolide

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Central Study Contacts

Wang Xipeng

CONTACT

+862125078999; steveoizzie@icloud.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2022
• First Posted: January 25, 2022
• Study Start: May 1, 2023
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)