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Not yet recruitingNCT05643703Updated Dec 9, 2022

Cesarean Section Defect Mechanism and Transvaginal Repair

An interventional study of Suture method in Cesarean Scar Defect; Transvaginal Diverticulum Resection, sponsored by Peking Union Medical College Hospital. Not yet recruiting. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2022-12-09.

Sponsored by Peking Union Medical College Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jun 2024, 2 years 3 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
300
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
Female
01

Study summary

Background and aims: Cesarean section defect (CSD) can cause abnormal uterine bleeding or impaired fertility, which severely impaire the quality of life in women of pregnant age. For women with moderate or severe CSD, surgery can be performed. The objectives of this study is to compare the efficacy and safety of different suture methods in the treatment of transvaginal diverticulum resection, and the underlying mechanism of CSD occurrence.

Methods: The patients diagnosed with CSD will be enrolled and randomizely assigned into suture method A and suture method. The fresh isolated tissue and swab of different sites in genital tract will be collected for NGS, microbiome, metabonomics and proteomics analysis.

Hypothesis: The menstruation will be analyzed at different following time. The other clinical information will be also collected, including age at surgery, skin-to skin operative time, estimated blood loss (EBL). The perioperative complications, postoperative hopitalization, cost for hospital stay, blasser/intestinal function recovery will also be compared between two gorup. The outcome of fertility will be compared, such as the premature birth, premature rupture of membranes, and rupture of uterus. The clinical manifestation related to CSD and recurrence will be followed. Besides, the underlying mechanism will be analyzed.

02

Conditions studied

  • Cesarean Scar Defect; Transvaginal Diverticulum Resection
03

In context

Lead sponsor

Peking Union Medical College Hospital is the lead sponsor of 1,148 studies on the registry; 473 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Browse Peking Union Medical College Hospital studies →

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

04

Who can participate

Ages eligible
18 Years to 40 Years
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

  1. Age ≥ 18 years, premenopausal female;
  2. The scar is the transverse incision of the lower segment of the uterus (one or more times);
  3. The following abnormal uterine bleeding occurred after cesarean section: prolonged menstruation/endless menstruation ≥ 14 days, menstrual bleeding;
  4. Transvaginal three-dimensional ultrasound/pelvic MRI plain scan showed that the thickness of residual muscular layer at the top of diverticulum was less than 3 mm;
  5. The effect of drug treatment is poor, and it is difficult to adhere to long-term drug treatment or surgical treatment;
  6. HGB > 100g/L before operation;
  7. Hysteroscopy excluded endometrial lesions;
  8. The patient or family members can understand the study protocol and voluntarily participate in the study, and provide written informed consent.

Exclusion criteria

Exclusion Criteria:

  1. The data of cesarean section is not complete, and the previous cesarean section method cannot be determined;
  2. Abnormal uterine bleeding caused by endocrine disorders (thyroid dysfunction, luteal insufficiency), endometrial lesions, uterine fibroids, gynecological tumors, blood system diseases, pelvic infections, intrauterine devices, etc;
  3. Infertility patients caused by female oviduct infertility, intrauterine adhesion infertility, uterine malformation, polycystic ovary syndrome, male infertility, etc;
  4. Patients with other serious gynecological diseases and/or serious physical or psychological diseases;
  5. Pregnancy (women of childbearing age were positive in pregnancy test at baseline or did not receive pregnancy test), and women in lactation;
  6. Patients who are unable to complete the follow-up;
  7. The patient or family members could not understand the conditions and objectives of the study and did not agree to participate in the study.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
300 participants (estimated)

Study arms

  • Experimental
    One-layered Suture

    One-layered Suture in transvaginal diverticulum resection

    Procedure: Suture method

  • Experimental
    Two-layered Suture

    Two-layered Suture in transvaginal diverticulum resection

    Procedure: Suture method

Interventions

  • ProcedureSuture method

    One-layered Suture: Single layer intermittent suture; Two-layered Suture:Single layer intermittent suture plus U type reinforcement stitching

06

What researchers measure

Primary outcomes

  1. Prolongation of menstrual period

    Patients' subject description of the duration of menstrual period, which is defined as the first day of menstruation to the end day

    Time frame: 3 month after surgery

Secondary outcomes

  1. fertility outcome

    record the post-operative fertility outcome, including natural pregnancy or assisted reproduction, and the correspondence fertility outcome, such as premature birth, premature rupture of membranes, etc.

    Time frame: within 5 years after surgery

Other outcomes

  1. objective measurement of caesarean scar diverticulum

    The difference of different diameters of caesarean scar diverticulum before and after surgery

    Time frame: within 1 years after surgery

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Dec 2022; primary completion for Jun 2024, 18 months later.

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

Registered
Nov 29, 2022
First posted
Dec 9, 2022
StartEst.
Dec 20, 2022
Primary completionEst.
Jun 30, 2024
CompletionEst.
Nov 20, 2026
Last update
Dec 9, 2022
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 Dec 9, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05643703
Lead sponsor
Peking Union Medical College Hospital
Responsible party
Sponsor
First posted
Dec 9, 2022
Start date
Dec 20, 2022 (estimated)
Primary completion
Jun 30, 2024 (estimated)
Completion
Nov 20, 2026 (estimated)
Last update
Dec 9, 2022

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 Dec 2022. You cannot join it, but the record below documents what was studied.

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