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Recruiting NCT05206682

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

No phase Interventional Cesarean Section; Dehiscence

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Leuprorelin.
Who it may be relevant to
Registry conditions: Cesarean Section; Dehiscence. Basic parameters: 18 years — 50 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

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

Primary outcome measures

  • thickness of the remaining muscular layer (TRM) (mm) [Time frame: 12 weeks after vaginal repair of CSD]
  • Duration of menstruation (day) [Time frame: 12 weeks after vaginal repair of CSD]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Shanghai Jiaotong University xinhua hospital — Shanghai

Identifiers

NCT: NCT05206682 · XH-21-013

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗