NCT04409249

Brief Summary

COVID-19 is a disease whose development, prognosis mechanism and immune status are still unknown. The aim of the study is to determine the relationship between clinical and laboratory data and the severity of the disease by evaluating the hematological and radiological features of the patients. The secondary aim is to determine the predictive values of clinical and laboratory data for the severity of COVID-19.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
155

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

March 15, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 25, 2020

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

May 28, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 28, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 1, 2020

Completed
Last Updated

July 2, 2020

Status Verified

July 1, 2020

Enrollment Period

2 months

First QC Date

May 28, 2020

Last Update Submit

July 1, 2020

Conditions

COVID-19Prognostic FactorsPregnancy

Outcome Measures

Primary Outcomes (1)

  • the factors affecting prognosis in pregnant women diagnosed with COVID-19

    3 Months

Interventions

imaging, blood testsDIAGNOSTIC_TEST

PCR and CT results, hemogram, urea, creatinine, AST, ALT, LDH, D-Dimer, ferritin, lipase, amylase, CRP, procalcitonin, albumin, total protein, coagulation tests-PT, APTT, Fibrinogen-, Troponin T, CK , electrolytes, blood gas, bilirubins

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Tertiary center data

You may qualify if:

  • Being pregnant with a diagnosis of COVID-19 between the ages of 18-45

You may not qualify if:

  • Suspected COVID-19 diagnosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kanuni Sultan Suleyman Training and Research Hospital

Istanbul, Halkali, 34307, Turkey (Türkiye)

Location

MeSH Terms

Conditions

COVID-19

Interventions

Diagnostic ImagingHematologic Tests

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and ProceduresDiagnosisClinical Laboratory TechniquesInvestigative Techniques

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Specialist of Obstetrics and Gynecology, Principal Investigator

Study Record Dates

First Submitted

May 28, 2020

First Posted

June 1, 2020

Study Start

March 15, 2020

Primary Completion

May 25, 2020

Study Completion

May 28, 2020

Last Updated

July 2, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL

Locations

TU(1)