Cesarean Section ComplicationsNCT05669300
Uterine Closure for Cesarean Section: a Novel Technique
An observational study of Cesarean Section Complications and Cesarean Section; Dehiscence, run by Recep Tayyip Erdogan University Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
In here we want to describe a new technique to uterin closure at caesarean section which has been performed about 20 years by Bülent Yılmaz. The technique (we suggest the name of the technique as Yılmaz technique) provide less resuturing need when closing the uterus in cesarean section, bringing together better wound… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Cesarean Section Complications, Cesarean Section; Dehiscence
- What is being tested?
- Yilmaz Suturation
- Type of treatment
- Surgery or procedure
- How many people
- 360 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2022to 20 Dec 2022
- 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 45 years
- Women only
- Adult
Study population: In this retrospective study pregnant women who had a cesarean delivery in our hospital between 1 January 2021 and 31 April 2022 were included. Decrease of postoperative hemoglobine levels between Yilmaz Tecnique and single layer continue locked suturation compared
Who may be able to join
- patients underwent to ceseren section and
- singleton
- alive fetus
Who cannot join
- The patients with
- uterine atonia,
- coagulaopathy,
- plasenta previa
- blood transfusion -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: All Layer Continuous Paralel Uterine Closure for Cesarean Section: a Novel Technique
In here we want to describe a new technique to uterin closure at caesarean section which has been performed about 20 years by Bülent Yılmaz. The technique (we suggest the name of the technique as Yılmaz technique) provide less resuturing need when closing the uterus in cesarean section, bringing together better wound edges, providing more effective suture in thin uteruses, stopping active bleeding areas with the same suture, thus enabling to complete the surgery at low cost by using a single suture material in almost all cases.
The aim of this study is to describe the technique and compare the blood loss of patients in caserean section between Yılmaz technique and single layer continue locked suturation .
Read the detailed description
The participants of the study were divided into two groups as uterine closure with Yilmaz technique (study group) and single layer continue locked suturation (control group). Maternal age, gestationale age, fetal weight, preoperative and postoperative hemoglobin levels are recorded. Hemoglobin decrease was calculated by subtracting the postoperative hemoglobin value from the preoperative hemoglobin values of the pregnant women.The postoperative hemoglobine decrease of the groups are compared.
- Being tested
- Yilmaz Suturation
- Keywords
- cesarean section, uterine closure, novel technique
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yilmaz SuturationProcedure or surgery
uterine closure with Yilmaz Technique and single layer continue locked suturation
| Study group | Role | What they receive |
|---|---|---|
| Yilmaz Technique | the patients underwent ceserean section and uterus closed with Yilmaz Technique Receives: Procedure: Yilmaz Suturation | |
| single layer continue locked suturation | the patients underwent ceserean section and uterus closed with single layer continue locked suturation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease of hemoglobine levels
Comparision of postoperative decrease of hemoglobine levels between Yilmaz Technique and single layer continue locked suturation
Measured: 1 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2022
- Study start1 Dec 2022
- Primary completion15 Dec 2022
- Study completion20 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean Section ComplicationsStudies 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
- Retrospective
- Enrolment
- 360 participants (actual)
Sponsor and investigators
- Lead sponsor
- Recep Tayyip Erdogan University Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehmet Kagitci, Recep Tayyip Erdogan University Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05669300
- Sponsor's protocol ID
- 2022/178
- Status last verified
- Dec 2022
- First submitted
- 20 Dec 2022
- Last updated
- 30 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Decrease of the postoperative Hemoglobine levels will be shared
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- All Layer Continuous Paralel Uterine Closure for Cesarean Section: a Novel Technique
- ClinicalTrials.gov ID
- NCT05669300
- Acronym / sponsor ID
- 2022/178
- Keywords
- cesarean section, uterine closure, novel technique
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 360 participants (actual)
- Lead sponsor
- Recep Tayyip Erdogan University Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 15 Dec 2022 (actual)
- Study completion
- 20 Dec 2022 (actual)
- First posted
- 30 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.
In here we want to describe a new technique to uterin closure at caesarean section which has been performed about 20 years by Bülent Yılmaz. The technique (we suggest the name of the technique as Yılmaz technique) provide less resuturing need when closing the uterus in cesarean section, bringing together better wound edges, providing more effective suture in thin uteruses, stopping active bleeding areas with the same suture, thus enabling to complete the surgery at low cost by using a single suture material in almost all cases.
The aim of this study is to describe the technique and compare the blood loss of patients in caserean section between Yılmaz technique and single layer continue locked suturation .
Detailed description
The participants of the study were divided into two groups as uterine closure with Yilmaz technique (study group) and single layer continue locked suturation (control group). Maternal age, gestationale age, fetal weight, preoperative and postoperative hemoglobin levels are recorded. Hemoglobin decrease was calculated by subtracting the postoperative hemoglobin value from the preoperative hemoglobin values of the pregnant women.The postoperative hemoglobine decrease of the groups are compared.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Yilmaz Technique | – | Procedure: Yilmaz Suturationthe patients underwent ceserean section and uterus closed with Yilmaz Technique |
| single layer continue locked suturation | – | –the patients underwent ceserean section and uterus closed with single layer continue locked suturation |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- In this retrospective study pregnant women who had a cesarean delivery in our hospital between 1 January 2021 and 31 April 2022 were included. Decrease of postoperative hemoglobine levels between Yilmaz Tecnique and single layer continue locked suturation compared
Key inclusion criteria (3 listed)
- patients underwent to ceseren section and
Key exclusion criteria (5 listed)
- The patients with
- uterine atonia,
- coagulaopathy,
- plasenta previa
- blood transfusion -
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 |
|---|---|---|
| Yilmaz Suturationuterine closure with Yilmaz Technique and single layer continue locked suturation | Procedure or surgery | Yilmaz Technique |
Primary outcome
Decrease of hemoglobine levels
Time frame: 1 months
Comparision of postoperative decrease of hemoglobine levels between Yilmaz Technique and single layer continue locked suturation
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 30 Dec 2022.
- Individual participant dataSharing planned: No. Decrease of the postoperative Hemoglobine levels will be shared
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Cesarean Section Complications and Cesarean Section; Dehiscence, run by Recep Tayyip Erdogan University Training and Research 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 30 Dec 2022. 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?
Decrease of hemoglobine levels (time frame: 1 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 30 Dec 2022.