NCT01856387

Brief Summary

Neutrophil/lymphocyte ratio (NLR) is a marker of systemic inflammation and endothelial dysfunction. In recent years, it has been reported that the individual components of the differential white cell count, specifically the neutrophil and lymphocyte counts,may have clinical utility in predicting diseases. An elevated NLR has been shown to be a prognostic indicator in various malignancies. İn the literature, many studies have been shown that NLR have predictive value in determining the prognosis of various diseases (cardiac or noncardiac diseases ). However, little is known about the predictive values of NLR in pregnancy complications. This study aimed to evaluate the potential predictive value of NLR in preeclampsia- eclampsia.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2013

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

May 4, 2013

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 17, 2013

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

March 18, 2014

Status Verified

May 1, 2013

Enrollment Period

11 months

First QC Date

May 4, 2013

Last Update Submit

March 16, 2014

Conditions

Keywords

preeclampsiaeclampsiapredictionneutrophil-to Lymphocyte ratio

Outcome Measures

Primary Outcomes (1)

  • the effect of neutrophil lymphocyte ratio in preeclampsia eclampsia

    during 6 months ,the patients who was recorded with preeclampsi/eclampsia at our hospital ,first trimester whole blood count was taken and neutrophil lymphocyte ratio was calculated and recorded

    up to 6 months

Study Arms (2)

normal pregnancy outcomes

do not expect poor pregnancy outcomes on normal patients

Biological: high neutrophil to lymphocyte ratioOther: normal neutrophil-to Lymphocyte ratio

adverse pregnancy outcome

high ratio of Neutrophil / lymphocyte ratio may predict preeclampsia eclampsia

Biological: high neutrophil to lymphocyte ratioOther: normal neutrophil-to Lymphocyte ratio

Interventions

adverse pregnancy outcomenormal pregnancy outcomes
adverse pregnancy outcomenormal pregnancy outcomes

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

first trimester pregnant

You may qualify if:

  • pregnant women who developing preeclampsia eclampsia at pregnancy

You may not qualify if:

  • Known chronically maternal disease multiple pregnancy older than 40 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zekai Tahir Burak Maternity Teaching Hospital

Ankara, Turkey (Türkiye)

RECRUITING

Biospecimen

Retention: NONE RETAINED

whole blood, serum, white cells

MeSH Terms

Conditions

Pre-EclampsiaEclampsia

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-InducedPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • ayse kirbas

    Zekai Tahir Burak Women's Health Research and Education Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ayse Kirbas, MD

Study Record Dates

First Submitted

May 4, 2013

First Posted

May 17, 2013

Study Start

May 1, 2013

Primary Completion

April 1, 2014

Study Completion

May 1, 2014

Last Updated

March 18, 2014

Record last verified: 2013-05

Locations