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

A Randomized Controlled Study of Uterine Incision Diverticular Repair During Repeated Cesarean Section

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06612957
Enrollment
60
Registered
2024-09-25
Start date
2025-05-20
Completion date
2027-06-01
Last updated
2025-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cesarean Scar Diverticulum

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

Interventions

PROCEDURERepair of uterine cicatricial diverticulum

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

Sponsors

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

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
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.

Design outcomes

Primary

MeasureTime frameDescription
Regularity of postpartum menstrual cycleSix months after cesarean sectionWhether the symptoms of menorrhagia after cesarean section disappear or improve

Contacts

Primary ContactZijun Wang, bachelor
18018590678@163.com+8618018590678

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026