Uterus; ScarNCT05517018
UTERUS CLOSURE TECHNIQUES and Uterine Niche Formation
An observational study of Uterus; Scar, run by Gaziosmanpasa Research and Education Hospital at 1 site in Turkey (Türkiye).
Trial summary
We aimed to compare 3 different uterotomy suture techniques with each other and evaluate them in terms of niche formation.1- one layer 2- double layer 3- purse string (TURAN technique) Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Uterus; Scar
- How many people
- 159 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2022to 20 Jan 2023
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult
Study population: Patients who need to have a cesarean section will be included in the study.participants will be randomly divided into 3 groups according to the cesarean section technique.During the cesarean section, the uterus will be closed using different techniques for each of the 3 groups.6 weeks after the operation, they will be called for control and evaluated in terms of niche formation. and rezidue myometrial tissue
Who may be able to join
- have a cesarean section necessity
- be over 18 years old
- being younger than 40
Who cannot join
- emergency cesarean section
- Being under 37 weeks pregnant
- multiple pregnancies
- having had uterine surgery
- uterine malformations
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gaziosmanpasa Training and Research Hospital
Istanbul, Gaziosmanpaşa, 32225
About this study
Official title: COMPARISON OF SINGLE, DOUBLE LAYER AND PURSE STRING TECHNIQUE (TURAN TECHNIQUE) STUR TYPES IN TERMS OF THE FORMATION OF UTERINE NICH FOR CLOSING THE UTERUS DURING CESERIAN SECTION
We aimed to compare 3 different uterotomy suture techniques with each other and evaluate them in terms of niche formation.1- one layer 2- double layer 3- purse string (TURAN technique)
Read the detailed description
It is thought that the formation of the uterine niche may be mostly due to the surgical technique.We aimed to compare 3 different uterotomy suture techniques with each other and evaluate them in terms of niche formation.1- one layer 2- double layer 3- purse string (TURAN technique).
- Conditions
- Uterus; Scar
- Medical subject headings
- Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| single layer uterotomy | 53 women with a single-layer uterotomy while closing the uterus during Ceserian | |
| double layer uterotomy | 53 women with a double layer uterotomy while closing the uterus during Ceserian | |
| purse string uterotomy | 53 women with a purse string uterotomy tecnique had used while closing the uterus during Ceserian |
What is being measured
The primary outcome is the main question the study is designed to answer.
the formation of a uterine niche
The formation of a niche will be considered a failure, while the absence of a niche will be considered a technical success.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2022
- Study start1 Jul 2022
- Primary completion30 Dec 2022
- Study completion20 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterus; 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 159 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gaziosmanpasa Research and Education Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Elif Yıldız, Gaziosmanpasa Research and Education Hospital
- Investigators
- elif yıldız, Principal investigator, Gaziosmanpasa Research and Education Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05517018
- Sponsor's protocol ID
- GaziosmanpasaTREHmmh
- Status last verified
- Apr 2023
- First submitted
- 24 Aug 2022
- Last updated
- 11 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COMPARISON OF SINGLE, DOUBLE LAYER AND PURSE STRING TECHNIQUE (TURAN TECHNIQUE) STUR TYPES IN TERMS OF THE FORMATION OF UTERINE NICH FOR CLOSING THE UTERUS DURING CESERIAN SECTION
- ClinicalTrials.gov ID
- NCT05517018
- Acronym / sponsor ID
- GaziosmanpasaTREHmmh
- Conditions
- Uterus; Scar
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 159 participants (actual)
- Lead sponsor
- Gaziosmanpasa Research and Education HospitalOther government
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 20 Jan 2023 (actual)
- First posted
- 26 Aug 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.
We aimed to compare 3 different uterotomy suture techniques with each other and evaluate them in terms of niche formation.1- one layer 2- double layer 3- purse string (TURAN technique)
Detailed description
It is thought that the formation of the uterine niche may be mostly due to the surgical technique.We aimed to compare 3 different uterotomy suture techniques with each other and evaluate them in terms of niche formation.1- one layer 2- double layer 3- purse string (TURAN technique).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| single layer uterotomy | – | –53 women with a single-layer uterotomy while closing the uterus during Ceserian |
| double layer uterotomy | – | –53 women with a double layer uterotomy while closing the uterus during Ceserian |
| purse string uterotomy | – | –53 women with a purse string uterotomy tecnique had used while closing the uterus during Ceserian |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients who need to have a cesarean section will be included in the study.participants will be randomly divided into 3 groups according to the cesarean section technique.During the cesarean section, the uterus will be closed using different techniques for each of the 3 groups.6 weeks after the operation, they will be called for control and evaluated in terms of niche formation. and rezidue myometrial tissue
Key inclusion criteria (3 listed)
- have a cesarean section necessity
- be over 18 years old
- being younger than 40
Key exclusion criteria (5 listed)
- emergency cesarean section
- Being under 37 weeks pregnant
- multiple pregnancies
- having had uterine surgery
- uterine malformations
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
the formation of a uterine niche
Time frame: 6 weeks
The formation of a niche will be considered a failure, while the absence of a niche will be considered a technical success.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2023.
- Individual participant dataSharing planned: No
Related trials for Uterus; 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
Active, not recruitingObservational study
Transvaginal Electromechanical Fragmentation and Removal of Large Uterus in a Sealed Bag: The First Group of Clinical Studies Balancing Scar - Free and Anti - Dissemination
Uterine Fibroids, Adenomyosis
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.
elif yıldız principal investigator
Gaziosmanpasa Research and Education Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Uterus; Scar, run by Gaziosmanpasa Research and Education Hospital 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 3 inclusion and 5 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: finished, as of the sponsor's last update on 11 Apr 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
the formation of a uterine niche (time frame: 6 weeks). 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 11 Apr 2023.