Actively Recruiting

Phase Not Applicable
Age: 18Years - 50Years
FEMALE
ID05206682

Comparison of Vaginal Repair With Leuprorelin Versus Vaginal Repair Alone for Cesarean Section Scar Defect

Led by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine · Updated on 2026-04-24

94

Participants Needed

1

Research Sites

34 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to evaluate the effects of vaginal repair surgery combined with Leuprorelin compared to vaginal repair alone in women diagnosed with Cesarean Section Scar Defect (CSD) complicated by adenomyosis. The study focuses on whether postponing the menstrual period after surgery can improve the healing and prognosis of the scar tissue. Women enrolled in the study will have abnormal uterine bleeding and prolonged menstrual flow related to their condition. Participants will undergo vaginal excision and suturing of the CSD. One group will receive subcutaneous injections of Leuprorelin three times over four weeks around the time of surgery to temporarily delay menstruation, which may reduce local inflammation and improve uterine conditions. The other group will receive vaginal repair without Leuprorelin. Both groups will be followed up to assess outcomes. During the study, participants will be examined at 6 months after surgery, with primary measures taken 12 weeks post-operation including the thickness of the remaining muscular layer at the scar site and the duration of menstruation. Researchers will monitor healing and changes in uterine tissue to assess the impact of the delayed period treatment. The study is randomized and open-label, with participation lasting from surgery to follow-up assessments.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 50Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Clearly diagnosed with Cesarean Section Scar Defect complicated with adenomyosis
  • Experiencing abnormal uterine bleeding with prolonged menstrual flow lasting more than 10 days
  • Thickness of the remaining muscular layer of the scar is less than 3 mm
  • Blood sugar and insulin levels within normal range
  • No serious medical problems with important organ functions normal
  • Uterine fibroids no larger than 5 cm
  • Signed informed consent to participate
Not Eligible

You will not qualify if you...

  • Unclear or indefinite diagnosis
  • Presence of malignant tumors
  • Severe medical problems such as severe liver, kidney, respiratory, heart diseases, uncontrolled diabetes, epilepsy, or organ dysfunction
  • Currently pregnant
  • Mental health disorders
  • Allergy to any ingredients of Leuprorelin
  • Unwillingness to comply with the study plan

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery

Duration - 1 day

Participants undergo vaginal excision and suture of the Cesarean Section Scar Defect.

1 surgical visit (in-person)

Treatment

Duration - 4 weeks

Participants receive vaginal repair with or without Leuprorelin injections to improve healing of the scar.

3 Leuprorelin injections over 4 weeks (in the experimental group)

Follow-up

Duration - 6 months

Participants are assessed 6 months after surgery to evaluate the healing and condition of the scar.

1 follow-up visit (in-person)

Trial Site Locations

Total: 1 location

1

Shanghai Jiaotong University xinhua hospital

Shanghai, Shanghai Municipality, China, 200092

Actively Recruiting

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Research Team

W

Wang Xipeng

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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