Uterine ScarCOSMOSSNCT05096910
Comparison Of Suture Materials on Sectio Scars (COSMOSS)
A study testing Uterine Closure with monofilament or polyfilament suture materials in people with Uterine Scar, run by Uludag University at 1 site in Turkey (Türkiye).
Trial summary
This multicenter prospective randomized controlled trial aims to investigate the ishtmocele rates after c-section delivery depending on using different suture materials for the uterine closure. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Uterine Scar
- What is being tested?
- Uterine Closure with monofilament or polyfilament suture materials
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 Sep 2020to 1 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- 18-40 yrs women
- Primary elective cesarean section
- First delivery
- Without any systemic diseases
Who cannot join
- emergent delivery
- previous c-section history
- congenital uterine abnormality
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Uludag University Scholl of medicine
Bursa, Turkey/bursa
GÜRKAN UNCU, 0224 2952541, guncu@gurkanuncu.org
About this study
Official title: COSMOSS Study, Comparison Of Suture Materials on Sectio Scars. A Multicenter Prospective Randomized Controlled Study
This multicenter prospective randomized controlled trial aims to investigate the ishtmocele rates after c-section delivery depending on using different suture materials for the uterine closure.
Read the detailed description
The study involves 5 health centers (two universities, three private hospitals). Patients who will undergo their first cesarean section because of any etiology (except emergent cases) will be included in the study. Operation Nurse will randomize the patients into two groups depending on the monofilament or poly filament suture material. Patients will be checked by transvaginal ultrasound on a postoperative day one, postoperative first month, and postoperative sixth month. As the primary result, the istmocele rates will be compared between the study groups.
- Conditions
- Uterine Scar
- Being tested
- Uterine Closure with monofilament or polyfilament suture materials
- Keywords
- cesarean section, isthmocele, uterine scar, suture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Uterine Closure with monofilament or polyfilament suture materialsProcedure or surgery
Postoperative 6th-month isthmocele rates
| Study group | Role | What they receive |
|---|---|---|
| Monofilament Suture Group | Active comparator | Monofilament sutures will be used for uterine closure. Receives: Procedure: Uterine Closure with monofilament or polyfilament suture materials |
| Polyfilament Suture Group | Active comparator | Polyfilament sutures will be used for uterine closure. Receives: Procedure: Uterine Closure with monofilament or polyfilament suture materials |
What is being measured
The primary outcome is the main question the study is designed to answer.
Isthmocele Rate
diagnosis of isthmocele during 6th month ultrasound check.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2021
- Study start4 Sep 2020
- Primary completion1 Jan 2022 (estimated)
- Study completion1 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine ScarStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uludag University
- Sponsor type
- University, hospital or other
- Collaborators
- Medicana Bursa Hospital, UMI Health Center, Ceylan Hospital
- Responsible party
- Principal investigator, GÜRKAN UNCU,PROF. MD, Uludag University
- Investigators
- Gurkan Uncu, Prof., Study director, Bursa Uludag University Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05096910
- Sponsor's protocol ID
- 10840098-772.02-E.43598
- Acronym
- COSMOSS
- Status last verified
- Oct 2021
- First submitted
- 14 Oct 2021
- Last updated
- 27 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COSMOSS Study, Comparison Of Suture Materials on Sectio Scars. A Multicenter Prospective Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05096910
- Acronym / sponsor ID
- COSMOSS / 10840098-772.02-E.43598
- Conditions
- Uterine Scar
- Keywords
- cesarean section, isthmocele, uterine scar, suture
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Uludag UniversityUniversity, hospital or other
- Collaborators
- Medicana Bursa Hospital, UMI Health Center, Ceylan Hospital
- Study start
- 4 Sep 2020 (actual)
- Primary completion
- 1 Jan 2022 (estimated)
- Study completion
- 1 Jan 2022 (estimated)
- First posted
- 27 Oct 2021 (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.
This multicenter prospective randomized controlled trial aims to investigate the ishtmocele rates after c-section delivery depending on using different suture materials for the uterine closure.
Detailed description
The study involves 5 health centers (two universities, three private hospitals). Patients who will undergo their first cesarean section because of any etiology (except emergent cases) will be included in the study. Operation Nurse will randomize the patients into two groups depending on the monofilament or poly filament suture material. Patients will be checked by transvaginal ultrasound on a postoperative day one, postoperative first month, and postoperative sixth month. As the primary result, the istmocele rates will be compared between the study groups.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Monofilament Suture Group | Active comparator | Procedure: Uterine Closure with monofilament or polyfilament suture materialsMonofilament sutures will be used for uterine closure. |
| Polyfilament Suture Group | Active comparator | Procedure: Uterine Closure with monofilament or polyfilament suture materialsPolyfilament sutures will be used for uterine closure. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 18-40 yrs women
- Primary elective cesarean section
- First delivery
- Without any systemic diseases
Key exclusion criteria (3 listed)
- emergent delivery
- previous c-section history
- congenital uterine abnormality
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 |
|---|---|---|
| Uterine Closure with monofilament or polyfilament suture materialsPostoperative 6th-month isthmocele rates | Procedure or surgery | Monofilament Suture Group, Polyfilament Suture Group |
Primary outcome
Isthmocele Rate
Time frame: 6 months
diagnosis of isthmocele during 6th month ultrasound check.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2021.
- Individual participant dataSharing planned: Undecided
Related trials for Uterine Scar
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Platelet Rich Plasma for Uterine Scar
Cesarean Section Complications, Uterine Bleeding
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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
Active, not recruiting
Comparison of Purse String Suture vs Transverse Mattress Suture to Maintain Hemostasis in Thinned-out Caesarean Sections Scars
Thinned-out Lower Uterine Segment Scar Previous Cesarean Section
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Transvaginal Electromechanical Fragmentation and Removal of Large Uterus in a Sealed Bag: The First Group of Clinical Studies Balancing Scar - Free and Anti - Dissemination
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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. This study is not recruiting at the moment.
Gurkan Uncu, Prof. study director
Bursa Uludag University Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Uterine Closure with monofilament or polyfilament suture materials in people with Uterine Scar, run by Uludag University at 1 site in Turkey (Türkiye).
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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 27 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kiper Aslan, M.D. (+905548127272, kiperaslan@yahoo.com.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Isthmocele Rate (time frame: 6 months). 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 27 Oct 2021.