- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04455321
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
Conditions
Intervention / Treatment
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
-
-
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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.
Sponsor
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
Keywords
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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