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

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

Status: Not yet enrolling

Conditions: Cesarean Scar Diverticulum

Treatments: Procedure: Repair of uterine cicatricial diverticulum

Study type: Interventional

Funder types: Other

Identifiers

NCT06612957

2024B06

Details and patient eligibility

About

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

Enrollment: 60 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Cesarean Section + Uterine Diverticulum Repair Group

Experimental group

Description:

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.

Treatment:

Procedure: Repair of uterine cicatricial diverticulum

Conventional Surgery Group

No Intervention group

Description:

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.