D-dimer Levels in Pregnant With COVID-19
Sponsor
Kanuni Sultan Suleyman Training and Research Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04389554
Collaborator
(none)
300
1
15
608.8
Study Details
Study Description
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.
Study Design
Study Type:
Observational [Patient Registry]
Actual Enrollment
:
300 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Assessment of D-dimer Levels in Pregnant Women Diagnosed With COVID-19
Actual Study Start Date
:
May 14, 2020
Actual Primary Completion Date
:
May 28, 2020
Actual Study Completion Date
:
May 29, 2020
Arms and Interventions
| Arm | 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.
|
Outcome Measures
Primary Outcome Measures
- Compare D-dimer values of COVID-19 patients and healthy pregnant women [one day]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 45 Years
Sexes Eligible for Study:
Female
Inclusion Criteria:
- Pregnant women with COVID-19
Exclusion Criteria:
- Having a chronic disease that raises D-dimer levels
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Kanuni Sultan Suleyman Training and Research Hospital | Istanbul | Turgut Ozal | Turkey |
Sponsors and Collaborators
- Kanuni Sultan Suleyman Training and Research Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
Responsible Party:
Merve Aldikactioglu Talmac, MD,
Specialist of Obstetrics and Gynecology,
Kanuni Sultan Suleyman Training and Research Hospital
ClinicalTrials.gov Identifier:
NCT04389554
Other Study ID Numbers:
- MTalmac
First Posted:
May 15, 2020
Last Update Posted:
Jun 1, 2020
Last Verified:
May 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Merve Aldikactioglu Talmac, MD,
Specialist of Obstetrics and Gynecology,
Kanuni Sultan Suleyman Training and Research Hospital
Additional relevant MeSH terms: