PreeclampsiaNCT01856387
The Effect of neutrophil-to Lymphocyte Ratio in Preeclampsia- Eclampsia
An observational study of Preeclampsia and Eclampsia, run by Zekai Tahir Burak Women's Health Research and Education Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Preeclampsia, Eclampsia
- What is being tested?
- high neutrophil to lymphocyte ratio and normal neutrophil-to Lymphocyte ratio
- How many people
- 600 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- May 2013to May 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: first trimester pregnant
Who may be able to join
- pregnant women who developing preeclampsia eclampsia at pregnancy
Who cannot join
- Known chronically maternal disease multiple pregnancy older than 40 years old
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Zekai Tahir Burak Maternity Teaching Hospital
Ankara
ayse kirbas, + 90 0 533 646 92 13, ayseozdemirkirbas@hotmail.com
ali ersoy, + 90 312-306-5000
About this study
Official title: the Predictive Value of neutrophil-to Lymphocyte Ratio on Preeclampsia- Eclampsia
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.
Read the detailed description
In recent years, have 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 literatüre 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 and PLR in gestational DM, preeclampsia and the other pregnancy complications.
Retrospective data were collected for patients who was diagnosed with , preeclampsia- eclampsia, The NLR was defined as the absolute neutrophil count divided by the absolute lymphocyte count.
- Conditions
- Preeclampsia, Eclampsia
- Being tested
- high neutrophil to lymphocyte ratio, normal neutrophil-to Lymphocyte ratio
- Keywords
- preeclampsia, eclampsia, prediction, neutrophil-to Lymphocyte ratio
- Medical subject headings
- Pre-Eclampsia, Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high neutrophil to lymphocyte ratioBiological
normal neutrophil-to Lymphocyte ratioOther
| Study group | Role | What they receive |
|---|---|---|
| normal pregnancy outcomes | do not expect poor pregnancy outcomes on normal patients Receives: Biological: high neutrophil to lymphocyte ratio; Other: normal neutrophil-to Lymphocyte ratio | |
| adverse pregnancy outcome | high ratio of Neutrophil / lymphocyte ratio may predict preeclampsia eclampsia Receives: Biological: high neutrophil to lymphocyte ratio; Other: normal neutrophil-to Lymphocyte ratio |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2013 (estimated)
- Study startMay 2013
- Primary completionApr 2014 (estimated)
- Study completionMay 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreeclampsiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zekai Tahir Burak Women's Health Research and Education Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayse Kirbas, Zekai Tahir Burak Women's Health Research and Education Hospital
- Investigators
- ayse kirbas, Principal investigator, Zekai Tahir Burak Women's Health Research and Education Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01856387
- Sponsor's protocol ID
- Zekai Tahir Burak
- Status last verified
- May 2013
- First submitted
- 4 May 2013
- Last updated
- 18 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- the Predictive Value of neutrophil-to Lymphocyte Ratio on Preeclampsia- Eclampsia
- ClinicalTrials.gov ID
- NCT01856387
- Acronym / sponsor ID
- Zekai Tahir Burak
- Conditions
- Preeclampsia, Eclampsia
- Keywords
- preeclampsia, eclampsia, prediction, neutrophil-to Lymphocyte ratio
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Zekai Tahir Burak Women's Health Research and Education HospitalUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Apr 2014 (estimated)
- Study completion
- May 2014 (estimated)
- First posted
- 17 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
In recent years, have 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 literatüre 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 and PLR in gestational DM, preeclampsia and the other pregnancy complications.
Retrospective data were collected for patients who was diagnosed with , preeclampsia- eclampsia, The NLR was defined as the absolute neutrophil count divided by the absolute lymphocyte count.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| normal pregnancy outcomes | – | Biological: high neutrophil to lymphocyte ratio, Other: normal neutrophil-to Lymphocyte ratiodo not expect poor pregnancy outcomes on normal patients |
| adverse pregnancy outcome | – | Biological: high neutrophil to lymphocyte ratio, Other: normal neutrophil-to Lymphocyte ratiohigh ratio of Neutrophil / lymphocyte ratio may predict preeclampsia eclampsia |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- first trimester pregnant
Key inclusion criteria (1 listed)
- pregnant women who developing preeclampsia eclampsia at pregnancy
Key exclusion criteria (1 listed)
- Known chronically maternal disease multiple pregnancy older than 40 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| high neutrophil to lymphocyte ratio | Biological | adverse pregnancy outcome, normal pregnancy outcomes |
| normal neutrophil-to Lymphocyte ratio | Other | adverse pregnancy outcome, normal pregnancy outcomes |
Primary outcome
the effect of neutrophil lymphocyte ratio in preeclampsia eclampsia
Time frame: up to 6 months
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zekai Tahir Burak Maternity Teaching Hospital
Ankara, Turkey (Türkiye)
ayse kirbas principal investigator
Zekai Tahir Burak Women's Health Research and Education Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Preeclampsia and Eclampsia, run by Zekai Tahir Burak Women's Health Research and Education Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the effect of neutrophil lymphocyte ratio in preeclampsia eclampsia (time frame: up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2014.