A Randomized Controlled Study of Uterine Incision Diverticulum Repair vs. no Repair During Second/Third Cesarean Section

NCT ID: NCT06612957

Last Updated: 2025-05-21

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-20
• Study Completion Date: 2027-06-01

Brief Summary

The goal of this study is to assess the efficacy and safety of uterine incision diverticulum repair during repeat cesarean section.The main questions it aims to answer are:

• Can this surgical method improve the symptom of menorrhagia？
• Is this procedure safe？ Researchers will compare experimental group(Cesarean section + diverticulum repair group) to control group(Conventional cesarean section group) to see if this surgical method works to treat or improve menorrhagia.

Participants will:

• randomly assigned 1:1 to the experimental group（repairing uterine diverticula during cesarean section) and the control group （Routine cesarean section without repairing the uterine incision diverticulum）
• visit the hospital 42 days after surgery
• followed up by telephone 6-12 months after surgery

Conditions

Cesarean Scar Diverticulum

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Cesarean Section + Uterine Diverticulum Repair Group

The original skin incision is used as the surgical incision. Tissues are sequentially separated until reaching the uterus. The original uterine incision'supper edge is used as the surgical incision for this procedure. The bladder is pushed down to fully expose the lower segment of the uterus. After the complete delivery of the fetus and placenta, the placental tissues are thoroughly cleaned, and the uterine scar diverticulum tissue in the lower segment is trimmed down to the original incision edge, making the lower edge of the incision normal uterine muscle tissue. The trimmed uterine scar diverticulum tissue is sent for pathological examination.

Group Type: EXPERIMENTAL

Repair of uterine cicatricial diverticulum

Intervention Type: PROCEDURE

Cut off the uterine cicatricial diverticular tissue in the lower portion of the uterus, and restore normal uterine muscle tissue.

Conventional Surgery Group

Participants randomly assigned to the control group undergo the same preoperative preparations and surgical procedures as the intervention group, except for the specific steps involving the repair of the uterine diverticulum.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Repair of uterine cicatricial diverticulum

Cut off the uterine cicatricial diverticular tissue in the lower portion of the uterus, and restore normal uterine muscle tissue.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Women aged ≥18 years, gestational age ≥37 weeks, singleton pregnancy, previous lower segment cesarean section, second or third cesarean section, and diagnosed with uterine incision diverticulum by imaging before or during early pregnancy.

Exclusion Criteria

• Preoperative indications of placenta accreta or previa, interdelivery interval less than 18 months from the last cesarean section, history of other uterine surgeries, and severe obstetric or medical complications requiring emergency care.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Shanghai First Maternal and Infant Health Hospital affiliated to Tongji University Medical School

OTHER

Sponsor Role: lead

Responsible Party

Xiaohua Liu

senior chief physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Zijun Wang, bachelor

Role: CONTACT

18018590678@163.com

+8618018590678

Other Identifiers

2024B06

Identifier Type: -

Identifier Source: org_study_id