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

Not Applicable

Not yet recruiting

• Conditions: Cesarean Scar Diverticulum

• Registration Number: NCT06612957
• Lead Sponsor: Shanghai First Maternal and Infant Health Hospital affiliated to Tongji University Medical School

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-09-23
• Study First Submitted QC: 2024-09-23
• Study First Posted: 2024-09-25
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-17
• Study Start: 2025-05-20
• Last Update Posted: 2025-05-21
• Primary Completion: 2026-06-01
• Study Completion: 2027-06-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Regularity of postpartum menstrual cycle	Six months after cesarean section	Whether the symptoms of menorrhagia after cesarean section disappear or improve