D-dimer Levels in Pregnant With COVID-19 | NCT04389554

Studies
D-dimer Levels in Pregnant With COVID-19

NCT04389554

Sponsor

Kanuni Sultan Suleyman Training and Research Hospital

Status

Completed

Last Update Posted

Jun 1, 2020Actual

Enrollment

300Actual

Phase

Not provided

Conditions

COVID-19
D-dimer

Interventions

Blood D-dimer assay

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 14, 2020Actual

Primary Completion Date

May 28, 2020Actual

Completion Date

May 29, 2020Actual

First Submitted Date

May 14, 2020

First Submission Date that Met QC Criteria

May 14, 2020

First Posted Date

May 15, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 28, 2020

Last Update Posted Date

Jun 1, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Merve Aldikactioglu Talmac, MD, Specialist of Obstetrics and Gynecology, Kanuni Sultan Suleyman Training and Research HospitalPrincipal Investigator

Lead Sponsor

Kanuni Sultan Suleyman Training and Research HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

3 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

300Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control Group		Healthy pregnant women	Other: Blood D-dimer assay
Study Group		Pregnant women with COVID-19	Other: Blood D-dimer assay

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Blood D-dimer assay	Other	Blood samples will be taken from the patients and will be examined by the ELISA method.	Control Group Study Group

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Pregnant women with COVID-19

Exclusion Criteria:

- Having a chronic disease that raises D-dimer levels

Accepts Healthy Volunteers

Not provided

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kanuni Sultan Suleyman Training and Research Hospital		Istanbul	Turgut Ozal		Turkey (Türkiye)

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
29975107	Background	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.

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections