UTERUS CLOSURE TECHNIQUES and Uterine Niche Formation

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)

Study Overview

• Status: Completed
• Conditions: Uterus; Scar

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 Type: Observational
• Enrollment (Actual): 159

Contacts and Locations

Study Locations

• Turkey
  • Gaziosmanpaşa
    • Istanbul, Gaziosmanpaşa, Turkey, 32225
      • Gaziosmanpasa Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Gaziosmanpasa Research and Education Hospital
• Investigators: Principal Investigator: elif yıldız, Gaziosmanpasa Research and Education Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2022
• Primary Completion (Actual): December 30, 2022
• Study Completion (Actual): January 20, 2023

Study Registration Dates

• First Submitted: August 24, 2022
• First Submitted That Met QC Criteria: August 24, 2022
• First Posted (Actual): August 26, 2022

Study Record Updates

• Last Update Posted (Actual): April 11, 2023
• Last Update Submitted That Met QC Criteria: April 8, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: GaziosmanpasaTREHmmh

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No