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CompletedNCT05517018Updated Apr 11, 2023

UTERUS CLOSURE TECHNIQUES and Uterine Niche Formation

An observational study in Uterus; Scar, sponsored by Gaziosmanpasa Research and Education Hospital. Completed at 1 site in Turkey. Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-04-11.

Sponsored by Gaziosmanpasa Research and Education Hospital · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
159
Ages
18 Years to 40 Years
Sex
Female
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Study 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 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).

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Conditions studied

  • Uterus; Scar
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In context

Lead sponsor

Gaziosmanpasa Research and Education Hospital is the lead sponsor of 122 studies on the registry; 29 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Female
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

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Observational model
Case-control
Time perspective
Prospective
Enrollment
159 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

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What researchers measure

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.

    Time frame: 6 weeks

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Study locations

1 site
  • Gaziosmanpasa Training and Research Hospital
    Istanbul, Gaziosmanpaşa 32225, Turkey
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 11, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05517018
Lead sponsor
Gaziosmanpasa Research and Education Hospital
Responsible party
Elif Yıldız (MEDİCAL DOCTOR, Gaziosmanpasa Research and Education Hospital) — Principal investigator
First posted
Aug 26, 2022
Start date
Jul 1, 2022
Primary completion
Dec 30, 2022
Completion
Jan 20, 2023
Last update
Apr 11, 2023

Study contacts

elif yıldız
principal investigator · Gaziosmanpasa Research and Education Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.

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