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Not yet recruitingNCT06612957Updated May 21, 2025

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

An interventional study of Repair of uterine cicatricial diverticulum in Cesarean Scar Diverticulum, sponsored by Shanghai First Maternal and Infant Health Hospital affiliated to Tongji University Medical School. Not yet recruiting. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-21.

Sponsored by Shanghai First Maternal and Infant Health Hospital affiliated to Tongji University Medical School · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jun 2026, 5 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study 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
02

Conditions studied

  • Cesarean Scar Diverticulum
03

In context

Cicatrix

611 studies on the registry are indexed under Cicatrix; 114 are open to participants now.

This study's planned enrollment of 60 is above the median of 40 across 512 interventional studies indexed under Cicatrix.

Browse Cicatrix studies →

Lead sponsor

Shanghai First Maternal and Infant Health Hospital affiliated to Tongji University Medical School is the lead sponsor of 3 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Cesarean Section + Uterine Diverticulum Repair Group

    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.

    Procedure: Repair of uterine cicatricial diverticulum

  • No intervention
    Conventional Surgery Group

    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.

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.

06

What researchers measure

Primary outcomes

  1. Regularity of postpartum menstrual cycle

    Whether the symptoms of menorrhagia after cesarean section disappear or improve

    Time frame: Six months after cesarean section

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No — no share

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for May 2025; primary completion for Jun 2026, 12 months later.

Of 173 non-industry interventional studies with no phase under Cicatrix, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 36. This study's planned 12 months is below that.

Counting every sponsor, half of 206 studies reached it within 18 months; a quarter within 8 and three quarters within 36.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 23, 2024
First posted
Sep 25, 2024
StartEst.
May 20, 2025
Primary completionEst.
Jun 1, 2026
CompletionEst.
Jun 1, 2027
Last update
May 21, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 21, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06612957
Lead sponsor
Shanghai First Maternal and Infant Health Hospital affiliated to Tongji University Medical School
Responsible party
Xiaohua Liu (senior chief physician, Shanghai First Maternal and Infant Health Hospital affiliated to Tongji University Medical School) — Principal investigator
First posted
Sep 25, 2024
Start date
May 20, 2025 (estimated)
Primary completion
Jun 1, 2026 (estimated)
Completion
Jun 1, 2027 (estimated)
Last update
May 21, 2025

Study contacts

Zijun Wang, bachelor
Contact
18018590678@163.com
+8618018590678

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in May 2025. You cannot join it, but the record below documents what was studied.

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