- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05092568
Comparison of General Characteristics of Patients Diagnosed COVID-19 (Coronavirus )Positive Followed In Service (COVID-19)
May 5, 2022 updated by: Sevim Özge Özdemir, Saglik Bilimleri Universitesi
Comparison of General Characteristics of Patients Diagnosed COVID-19 Positive Followed In Service
comparison of general characteristics of patients diagnosed COVID-19 positive followed In service
Study Overview
Status
Recruiting
Conditions
Detailed Description
After the explanation about the study is made, informed consent form will be obtained from the pregnant women who were hospitalized in the pandemic gynecology service (D block 10th floor pandemic obstetrics service) due to COVID-19 and who agreed to participate in the study.
In our study, the clinical status of pregnant patients with COVID-19 positive test results, who were followed up and treated in the pandemic service in Basaksehir City Hospital, will be obtained by asking the patient about the symptoms and vaccination status in the patient follow-up form prepared in advance.
Laboratory findings and imaging results ( CT/ anteroposterior X-ray) will be obtained from the recorded data.
Study Type
Observational
Enrollment (Anticipated)
45
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Ozge MD Ozdemir, MD
- Phone Number: 9005326384089
- Email: drozgeozde@gmail.com
Study Locations
-
-
İstanbul
-
Başaksehir, İstanbul, Turkey, 34480
- Recruiting
- Department of Obstetrics and Gynecology, Maternal-Fetal Medicine Unit, Başakşehir City Hospital, Hamidiye School of Medicine, University of Health Sciences,
-
Contact:
- özge Ö özdemir, MD
- Phone Number: 05326384089
- Email: drozgeozde@gmail.com
-
-
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
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Probability Sample
Study Population
Pregnant patients with positive COVID-19 test results, who were followed up and treated in the pandemic service of Çam and Sakura City Hospital.
Description
Inclusion Criteria: Pregnant patients positive COVID-19 test results followed up and treated in the pandemic service of Çam and Sakura City Hospital.
Exclusion Criteria: no exclusion criteria
-
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
Cohorts and Interventions
Group / Cohort |
|---|
|
covid pregnancy
Pregnant patients with positive polymerase chain reaction assay COVID-19 test results, who were followed up and treated in the pandemic service of Başakşehir Çam and Sakura City Hospital.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of Participants
Time Frame: Two months
|
Number of Participants diagnosed of polymerase chain reaction assay Positive COVID-19 followed İn service
|
Two months
|
|
Number of vaccinated participants
Time Frame: Two months
|
Vaccinated patients who were followed up in the service due to COVID-19
|
Two months
|
|
Number of non-vaccinated Participants
Time Frame: Two months
|
non-vaccinated patients who were followed up in the service due to COVID-19
|
Two months
|
|
rate of non-vaccinated -vaccinated Participants
Time Frame: Two months
|
rate of non-vaccinated- vaccinated Participants who were followed up in the service due to COVID-19
|
Two months
|
|
rate of covid symptoms
Time Frame: Two months
|
rate of covid common symptoms (cough, fever, shortness of breath ,sore throat ) in vaccinated and unvaccinated patients
|
Two months
|
|
rate of inflammatory parameters
Time Frame: Two months
|
rate of lymphocyte and albumin levels , C-reactive protein (CRP), D-dimer, Ferritin, lactate dehydrogenase(LDH), neutrophil lymphocyte ratio (NLR), platelet lymphocyte ratio (PLR) and C-reactive protein albumin ratio (CAR) levels in vaccinated and unvaccinated patients
|
Two months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ozge Ozdemir, Saglik Bilimleri Universitesi
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)
May 5, 2022
Primary Completion (ANTICIPATED)
July 15, 2022
Study Completion (ANTICIPATED)
July 15, 2022
Study Registration Dates
First Submitted
October 22, 2021
First Submitted That Met QC Criteria
October 22, 2021
First Posted (ACTUAL)
October 25, 2021
Study Record Updates
Last Update Posted (ACTUAL)
May 6, 2022
Last Update Submitted That Met QC Criteria
May 5, 2022
Last Verified
May 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- COVID-19
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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