NCT05517018

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)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
159

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 24, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 26, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2022

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2023

Completed
Last Updated

April 11, 2023

Status Verified

April 1, 2023

Enrollment Period

6 months

First QC Date

August 24, 2022

Last Update Submit

April 8, 2023

Conditions

Uterus; Scar

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (3)

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

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability 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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gaziosmanpasa Training and Research Hospital

Istanbul, Gaziosmanpaşa, 32225, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cicatrix

Condition Hierarchy (Ancestors)

FibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • elif yıldız

    Gaziosmanpasa Research and Education Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MEDİCAL DOCTOR

Study Record Dates

First Submitted

August 24, 2022

First Posted

August 26, 2022

Study Start

July 1, 2022

Primary Completion

December 30, 2022

Study Completion

January 20, 2023

Last Updated

April 11, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)