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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05206682
Enrollment
94
Registered
2022-01-25
Start date
2023-05-01
Completion date
2027-12-30
Last updated
2026-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cesarean Section; Dehiscence

Keywords

Cesarean Section Scar Defect, Zoladex, vaginal repair

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.

Interventions

DRUGLeuprorelin

Leuprorelin will be used to postpone period after vaginal repair.

Sponsors

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
thickness of the remaining muscular layer (TRM) (mm)12 weeks after vaginal repair of CSDThe thickness of the remaining muscular layer is measured by magnetic resonance imaging (MRI)
Duration of menstruation (day)12 weeks after vaginal repair of CSDDuration of menstruation (day)

Countries

China

Contacts

CONTACTWang Xipeng
steveoizzie@icloud.com+862125078999

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 25, 2026