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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05092568
Other study ID # COVID-19
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 5, 2022
Est. completion date July 15, 2022

Study information

Verified date May 2022
Source Saglik Bilimleri Universitesi
Contact Ozge MD Ozdemir, MD
Phone 9005326384089
Email drozgeozde@gmail.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

comparison of general characteristics of patients diagnosed COVID-19 positive followed In service


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 45
Est. completion date July 15, 2022
Est. primary completion date July 15, 2022
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility 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 Design


Locations

Country Name City State
Turkey Department of Obstetrics and Gynecology, Maternal-Fetal Medicine Unit, Basaksehir City Hospital, Hamidiye School of Medicine, University of Health Sciences, Basaksehir Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Saglik Bilimleri Universitesi

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Participants Number of Participants diagnosed of polymerase chain reaction assay Positive COVID-19 followed In service Two months
Primary Number of vaccinated participants Vaccinated patients who were followed up in the service due to COVID-19 Two months
Primary Number of non-vaccinated Participants non-vaccinated patients who were followed up in the service due to COVID-19 Two months
Primary rate of non-vaccinated -vaccinated Participants rate of non-vaccinated- vaccinated Participants who were followed up in the service due to COVID-19 Two months
Primary rate of covid symptoms rate of covid common symptoms (cough, fever, shortness of breath ,sore throat ) in vaccinated and unvaccinated patients Two months
Primary rate of inflammatory parameters 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
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