Ignite Creation Date:
2025-12-24 @ 6:43 PM
Ignite Modification Date:
2025-12-24 @ 6:43 PM
Study NCT ID:
NCT06612957
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-05-21
First Post:
2024-09-23
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Randomized Controlled Study of Uterine Incision Diverticulum Repair vs. no Repair During Second/Third Cesarean Section
Sponsor:
Shanghai First Maternal and Infant Health Hospital affiliated to Tongji University Medical School
Organization:
Study Overview
Official Title:
A Randomized Controlled Study of Uterine Incision Diverticular Repair During Repeated Cesarean Section
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
* 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:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: