D-dimer Levels in Pregnant With COVID-19

May 28, 2020 updated by: Merve Aldikactioglu Talmac, MD, Kanuni Sultan Suleyman Training and Research Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Turgut Ozal
      • Istanbul, Turgut Ozal, Turkey
        • Kanuni Sultan Suleyman Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • Pregnant women with COVID-19

Exclusion Criteria:

- Having a chronic disease that raises D-dimer levels

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Control Group
Healthy pregnant women
Other: Blood D-dimer assay
Blood samples will be taken from the patients and will be examined by the ELISA method.
Study Group
Pregnant women with COVID-19
Other: Blood D-dimer assay
Blood samples will be taken from the patients and will be examined by the ELISA method.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Compare D-dimer values of COVID-19 patients and healthy pregnant women
Time Frame: one day
one day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kanuni Sultan Suleyman Training and Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 14, 2020

Primary Completion (ACTUAL)

May 28, 2020

Study Completion (ACTUAL)

May 29, 2020

Study Registration Dates

First Submitted

May 14, 2020

First Submitted That Met QC Criteria

May 14, 2020

First Posted (ACTUAL)

May 15, 2020

Study Record Updates

Last Update Posted (ACTUAL)

June 1, 2020

Last Update Submitted That Met QC Criteria

May 28, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MTalmac

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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