NCT05092568

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 22, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 25, 2021

Completed
6 months until next milestone

Study Start

First participant enrolled

May 5, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2022

Completed
Last Updated

May 6, 2022

Status Verified

May 1, 2022

Enrollment Period

2 months

First QC Date

October 22, 2021

Last Update Submit

May 5, 2022

Conditions

Keywords

covid 19,vaccinecovid pregnancy vaccine

Outcome Measures

Primary Outcomes (6)

  • Number of Participants

    Number of Participants diagnosed of polymerase chain reaction assay Positive COVID-19 followed İn service

    Two months

  • Number of vaccinated participants

    Vaccinated patients who were followed up in the service due to COVID-19

    Two months

  • Number of non-vaccinated Participants

    non-vaccinated patients who were followed up in the service due to COVID-19

    Two months

  • 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

  • rate of covid symptoms

    rate of covid common symptoms (cough, fever, shortness of breath ,sore throat ) in vaccinated and unvaccinated patients

    Two months

  • 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

Study Arms (1)

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.

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Obstetrics and Gynecology, Maternal-Fetal Medicine Unit, Başakşehir City Hospital, Hamidiye School of Medicine, University of Health Sciences,

Başaksehir, Istanbul, 34480, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

COVID-19VacciniaSigns and Symptoms

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesPoxviridae InfectionsDNA Virus InfectionsPathological Conditions, Signs and Symptoms

Study Officials

  • Ozge Ozdemir

    Saglik Bilimleri Universitesi

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ozge MD Ozdemir, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

October 22, 2021

First Posted

October 25, 2021

Study Start

May 5, 2022

Primary Completion

July 15, 2022

Study Completion

July 15, 2022

Last Updated

May 6, 2022

Record last verified: 2022-05

Locations