Cesarean Scar Defect; Transvaginal Diverticulum ResectionNCT05643703
Cesarean Section Defect Mechanism and Transvaginal Repair
A study testing Suture method in people with Cesarean Scar Defect; Transvaginal Diverticulum Resection, run by Peking Union Medical College Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Cesarean Scar Defect; Transvaginal Diverticulum Resection
- What is being tested?
- Suture method
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 20 Dec 2022to 20 Nov 2026
- 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 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age ≥ 18 years, premenopausal female;
- The scar is the transverse incision of the lower segment of the uterus (one or more times);
- The following abnormal uterine bleeding occurred after cesarean section: prolonged menstruation/endless menstruation ≥ 14 days, menstrual bleeding;
- 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;
- The effect of drug treatment is poor, and it is difficult to adhere to long-term drug treatment or surgical treatment;
- HGB > 100g/L before operation;
- Hysteroscopy excluded endometrial lesions;
- The patient or family members can understand the study protocol and voluntarily participate in the study, and provide written informed consent.
Who cannot join
- The data of cesarean section is not complete, and the previous cesarean section method cannot be determined;
- 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;
- Infertility patients caused by female oviduct infertility, intrauterine adhesion infertility, uterine malformation, polycystic ovary syndrome, male infertility, etc;
- Patients with other serious gynecological diseases and/or serious physical or psychological diseases;
- Pregnancy (women of childbearing age were positive in pregnancy test at baseline or did not receive pregnancy test), and women in lactation;
- Patients who are unable to complete the follow-up;
- The patient or family members could not understand the conditions and objectives of the study and did not agree to participate in the study.
About this study
Official title: A Prospective Randomized Controlled Study on the Efficacy and Safety of Different Suture Methods for the Transvaginal Repair of Cesarean Section Defect and the Exploration of the Underlying Molecular Mechanism of the Defect Occurrence
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.
- Being tested
- Suture method
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Suture methodProcedure or surgery
One-layered Suture: Single layer intermittent suture; Two-layered Suture:Single layer intermittent suture plus U type reinforcement stitching
| Study group | Role | What they receive |
|---|---|---|
| One-layered Suture | Experimental | One-layered Suture in transvaginal diverticulum resection Receives: Procedure: Suture method |
| Two-layered Suture | Experimental | Two-layered Suture in transvaginal diverticulum resection Receives: Procedure: Suture method |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: within 5 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2022
- Study start20 Dec 2022 (estimated)
- Primary completion30 Jun 2024 (estimated)
- Study completion20 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean Scar Defect; Transvaginal Diverticulum ResectionStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05643703
- Sponsor's protocol ID
- K2724
- Status last verified
- Dec 2022
- First submitted
- 29 Nov 2022
- Last updated
- 9 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Controlled Study on the Efficacy and Safety of Different Suture Methods for the Transvaginal Repair of Cesarean Section Defect and the Exploration of the Underlying Molecular Mechanism of the Defect Occurrence
- ClinicalTrials.gov ID
- NCT05643703
- Acronym / sponsor ID
- K2724
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 20 Dec 2022 (estimated)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 20 Nov 2026 (estimated)
- First posted
- 9 Dec 2022 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| One-layered Suture | Experimental | Procedure: Suture methodOne-layered Suture in transvaginal diverticulum resection |
| Two-layered Suture | Experimental | Procedure: Suture methodTwo-layered Suture in transvaginal diverticulum resection |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Age ≥ 18 years, premenopausal female;
- The scar is the transverse incision of the lower segment of the uterus (one or more times);
- The following abnormal uterine bleeding occurred after cesarean section: prolonged menstruation/endless menstruation ≥ 14 days, menstrual bleeding;
- 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;
- The effect of drug treatment is poor, and it is difficult to adhere to long-term drug treatment or surgical treatment;
Key exclusion criteria (7 listed)
- The data of cesarean section is not complete, and the previous cesarean section method cannot be determined;
- 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;
- Infertility patients caused by female oviduct infertility, intrauterine adhesion infertility, uterine malformation, polycystic ovary syndrome, male infertility, etc;
- Patients with other serious gynecological diseases and/or serious physical or psychological diseases;
- Pregnancy (women of childbearing age were positive in pregnancy test at baseline or did not receive pregnancy test), and women in lactation;
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 |
|---|---|---|
| Suture methodOne-layered Suture: Single layer intermittent suture; Two-layered Suture:Single layer intermittent suture plus U type reinforcement stitching | Procedure or surgery | One-layered Suture, Two-layered Suture |
Primary outcome
Prolongation of menstrual period
Time frame: 3 month after surgery
Patients' subject description of the duration of menstrual period, which is defined as the first day of menstruation to the end day
1 secondary outcome
fertility outcome
Time frame: within 5 years after surgery
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 9 Dec 2022.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Suture method in people with Cesarean Scar Defect; Transvaginal Diverticulum Resection, run by Peking Union Medical College Hospital.
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 8 inclusion and 7 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 9 Dec 2022. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prolongation of menstrual period (time frame: 3 month after surgery). 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 9 Dec 2022.