The Effect of Suture Materials With Different Absorption Times on Isthmocele: Prospective Randomized Study

February 5, 2021 updated by: Selçuk Yetkinel, Baskent University
This study aims to investigate the effect of suture materials with different absorption times on istmocel.

Study Overview

Status

Completed

Study Type

Interventional

Enrollment (Actual)

102

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Adana, Turkey, 01000
        • Baskent University Adana Dr. Turgut Noyan Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • primary cesarean section
  • single pregnancy
  • 18-45 age

Exclusion Criteria:

  • Diabetes mellitus disease
  • inflammatory bowel disease
  • systemic lupus erythematosus disease
  • rheumatoid arthritis disease
  • previous uterine surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Vicryl
Single layer locked uterine closure with vicryl suture material
Effect of suture materials with different absorption times on istmocel
Experimental: rapide vicryl
Single layer locked uterine closure with rapide vicryl suture material
Effect of suture materials with different absorption times on istmocel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Istmocel
Time Frame: Six months
Istmocel area measurement with saline-infusion ultrasonography
Six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 15, 2020

Primary Completion (Actual)

August 1, 2020

Study Completion (Actual)

January 15, 2021

Study Registration Dates

First Submitted

June 29, 2020

First Submitted That Met QC Criteria

June 29, 2020

First Posted (Actual)

July 2, 2020

Study Record Updates

Last Update Posted (Actual)

February 9, 2021

Last Update Submitted That Met QC Criteria

February 5, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • KA19/170

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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