NCT06612957Not yet recruitingNot Applicable
A Randomized Controlled Study of Uterine Incision Diverticular Repair During Repeated Cesarean Section
Shanghai First Maternal and Infant Health Hospital affiliated to Tongji University Medical School0 sites60 target enrollmentStarted: May 20, 2025Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 60
- Primary Endpoint
- Regularity of postpartum menstrual cycle
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Regularity of postpartum menstrual cycle
Time Frame: Six months after cesarean section
Whether the symptoms of menorrhagia after cesarean section disappear or improve
Secondary Outcomes
No secondary outcomes reported
Investigators
Xiaohua Liu
senior chief physician
Shanghai First Maternal and Infant Health Hospital affiliated to Tongji University Medical School
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