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NCT04389554 Clinical Trial

D-dimer Levels in Pregnant With COVID-19

COVID-19 Clinical Trial

Official title:
Assessment of D-dimer Levels in Pregnant Women Diagnosed With COVID-19

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04389554
Other study ID # MTalmac
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 14, 2020
Est. completion date May 29, 2020

Study information
Verified date May 2020
Source Kanuni Sultan Suleyman Training and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

D-dimer measurements act as a global indicator of coagulation and activation of fibrinolytic systems. An optimal cut-off value for D-dimer and its effect on prognosis has not yet been assessed to predict mortality in admission. Therefore, studies comparing D-dimer values of COVID-19 patients and healthy pregnant women are needed. Our study gives us the opportunity to make this comparison.

Recruitment information / eligibility
Status Completed
Enrollment 300
Est. completion date May 29, 2020
Est. primary completion date May 28, 2020
Accepts healthy volunteers
Gender Female
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria:

- Pregnant women with COVID-19

Exclusion Criteria:

- Having a chronic disease that raises D-dimer levels

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Blood D-dimer assay
Blood samples will be taken from the patients and will be examined by the ELISA method.

Locations
Country Name City State
Turkey Kanuni Sultan Suleyman Training and Research Hospital Istanbul Turgut Ozal

Sponsors (1)
Lead Sponsor Collaborator
Kanuni Sultan Suleyman Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

Gutiérrez García I, Pérez Cañadas P, Martínez Uriarte J, García Izquierdo O, Angeles Jódar Pérez M, García de Guadiana Romualdo L. D-dimer during pregnancy: establishing trimester-specific reference intervals. Scand J Clin Lab Invest. 2018 Oct;78(6):439-442. doi: 10.1080/00365513.2018.1488177. Epub 2018 Jul 5. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Compare D-dimer values of COVID-19 patients and healthy pregnant women one day
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