NCT04389554

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 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

First Submitted

Initial submission to the registry

May 14, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

May 14, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 15, 2020

Completed
13 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 28, 2020

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 29, 2020

Completed
Last Updated

June 1, 2020

Status Verified

May 1, 2020

Enrollment Period

14 days

First QC Date

May 14, 2020

Last Update Submit

May 28, 2020

Conditions

Keywords

pregnancyCOVID-19D-dimer

Outcome Measures

Primary Outcomes (1)

  • Compare D-dimer values of COVID-19 patients and healthy pregnant women

    one day

Study Arms (2)

Control Group

Healthy pregnant women

Other: Blood D-dimer assay

Study Group

Pregnant women with COVID-19

Other: Blood D-dimer assay

Interventions

Blood samples will be taken from the patients and will be examined by the ELISA method.

Control GroupStudy Group

Eligibility Criteria

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

Kanuni Sultan Suleyman Training and Research Hospital Obstetrics and Gynecology Clinic Patients

You may qualify if:

  • Pregnant women with COVID-19

You may not qualify if:

  • \- Having a chronic disease that raises D-dimer levels

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kanuni Sultan Suleyman Training and Research Hospital

Istanbul, Turgut Ozal, Turkey (Türkiye)

Location

Related Publications (1)

  • Gutierrez Garcia I, Perez Canadas P, Martinez Uriarte J, Garcia Izquierdo O, Angeles Jodar Perez M, Garcia 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.

    PMID: 29975107BACKGROUND

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
3 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Specialist of Obstetrics and Gynecology

Study Record Dates

First Submitted

May 14, 2020

First Posted

May 15, 2020

Study Start

May 14, 2020

Primary Completion

May 28, 2020

Study Completion

May 29, 2020

Last Updated

June 1, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will share

Locations