UTERUS CLOSURE TECHNIQUES and Uterine Niche Formation | NCT05517018

Studies
UTERUS CLOSURE TECHNIQUES and Uterine Niche Formation

NCT05517018

Sponsor

Gaziosmanpasa Research and Education Hospital

Status

Completed

Last Update Posted

Apr 11, 2023Actual

Enrollment

159Actual

Phase

Not provided

Conditions

Uterus; Scar

Interventions

Not provided

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2022Actual

Primary Completion Date

Dec 30, 2022Actual

Completion Date

Jan 20, 2023Actual

First Submitted Date

Aug 24, 2022

First Submission Date that Met QC Criteria

Aug 24, 2022

First Posted Date

Aug 26, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 8, 2023

Last Update Posted Date

Apr 11, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Elif Yıldız, MEDİCAL DOCTOR, Gaziosmanpasa Research and Education HospitalPrincipal Investigator

Lead Sponsor

Gaziosmanpasa Research and Education HospitalOTHER_GOV

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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)

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).

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

159Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	6 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

have a cesarean section necessity
be over 18 years old
being younger than 40

Exclusion Criteria:

emergency cesarean section
Being under 37 weeks pregnant
multiple pregnancies
having had uterine surgery
uterine malformations

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
elif yıldız	Gaziosmanpasa Research and Education Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Gaziosmanpasa Training and Research Hospital		Istanbul	Gaziosmanpaşa	32225	Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D002921	Cicatrix

Ancestor Terms

ID	Term
D005355	Fibrosis
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

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Browse Branches

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