Cesarean Scar DiverticulumNCT06612957
A Randomized Controlled Study of Uterine Incision Diverticulum Repair vs. no Repair During Second/Third Cesarean Section
A study testing Repair of uterine cicatricial diverticulum in people with Cesarean Scar Diverticulum, run by Shanghai First Maternal and Infant Health Hospital affiliated to Tongji University Medical School.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cesarean Scar Diverticulum
- What is being tested?
- Repair of uterine cicatricial diverticulum
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 20 May 2025to 1 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Randomized Controlled Study of Uterine Incision Diverticular Repair During Repeated Cesarean Section
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.
Read more
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
- Conditions
- Cesarean Scar Diverticulum
- Being tested
- Repair of uterine cicatricial diverticulum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repair of uterine cicatricial diverticulumProcedure or surgery
Cut off the uterine cicatricial diverticular tissue in the lower portion of the uterus, and restore normal uterine muscle tissue.
| Study group | Role | What they receive |
|---|---|---|
| Cesarean Section + Uterine Diverticulum Repair Group | Experimental | 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. Receives: Procedure: Repair of uterine cicatricial diverticulum |
| Conventional Surgery Group | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Regularity of postpartum menstrual cycle
Whether the symptoms of menorrhagia after cesarean section disappear or improve
Measured: Six months after cesarean section
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2024
- Study start20 May 2025 (estimated)
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean Scar DiverticulumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai First Maternal and Infant Health Hospital affiliated to Tongji University Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaohua Liu, Shanghai First Maternal and Infant Health Hospital affiliated to Tongji University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06612957
- Sponsor's protocol ID
- 2024B06
- Status last verified
- May 2025
- First submitted
- 23 Sep 2024
- Last updated
- 21 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: no share
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Study of Uterine Incision Diverticular Repair During Repeated Cesarean Section
- ClinicalTrials.gov ID
- NCT06612957
- Acronym / sponsor ID
- 2024B06
- Conditions
- Cesarean Scar Diverticulum
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Shanghai First Maternal and Infant Health Hospital affiliated to Tongji University Medical SchoolUniversity, hospital or other
- Study start
- 20 May 2025 (estimated)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 25 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cesarean Section + Uterine Diverticulum Repair Group | Experimental | Procedure: Repair of uterine cicatricial diverticulumThe 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. |
| Conventional Surgery Group | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Repair of uterine cicatricial diverticulumCut off the uterine cicatricial diverticular tissue in the lower portion of the uterus, and restore normal uterine muscle tissue. | Procedure or surgery | Cesarean Section + Uterine Diverticulum Repair Group |
Primary outcome
Regularity of postpartum menstrual cycle
Time frame: Six months after cesarean section
Whether the symptoms of menorrhagia after cesarean section disappear or improve
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2025.
- Individual participant dataSharing planned: No. no share
Related trials for Cesarean Scar Diverticulum
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Comparing Decidual Inclusion vs. Exclusion in Uterine Suture Techniques During Cesarean Section to Improve Scar Thickness and Reduce Isthmocele Risk in Primiparous Women
Isthmocele, Cesarean Scar Diverticula
RecruitingObservational study
Clinical Value of Saline Infusion Sonohysterography in the Assessment of Cesarean Scar Defects
Infertility
Not yet recruiting
Cesarean Section Defect Mechanism and Transvaginal Repair
Cesarean Scar Defect; Transvaginal Diverticulum Resection
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Repair of uterine cicatricial diverticulum in people with Cesarean Scar Diverticulum, run by Shanghai First Maternal and Infant Health Hospital affiliated to Tongji University Medical School.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 May 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zijun Wang, bachelor (+8618018590678, 18018590678@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Regularity of postpartum menstrual cycle (time frame: Six months after cesarean section). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2025.