Maternal Periodontal Status and Cytokines in Preeclampsia

September 26, 2017 updated by: Hacer Sahin Aydinyurt

Maternal Periodontal Status and Gingival Crevicular Fluid Levels of Interleukin-6, Interleukin-35, and Interleukin-37 in Preeclampsia

Background: The purpose of this study is to examine the relationship between maternal preeclampsia and periodontal parameters and the correlation of these two disorders with maternal gingival crevicular fluid levels (GCF) of interleukin (IL)-35, interleukin-37 and interleukin-6. The investigators also investigated their relation to the severity of preeclampsia.

Methods: 82 preeclamptic women were recruited to the study (29 healthy pregnant women, 30 mild preeclamptic patient, 23 severe preeclamptic patient ). The clinical periodontal parameters and GCF samples were collected in the first day of puerperium.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

80

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

Probability Sample

Study Population

23 severe preeclamptic patient, 30 mild preeclamptic patient and 29 healthy pregnant women were recruited to this study.

Description

Inclusion Criteria:

  • Aged between 18 and 45 years
  • 25 and 40 weeks of gestation.
  • Healthy pregnants, mild and severe preeclampsia

Exclusion Criteria:

  • Patients with accompanying diseases
  • multiple gestations
  • congenital abnormalities were excluded from the study.

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
healthy pregnants
Diagnostic test: gingival crevicular fluid collection
mild preeclampsia
severe preeclampsia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
maternal periodontal clinical parameters and IL-37 and IL-35 and IL-6 levels
Time Frame: 6 months
IL-37 IL-35 and IL-6 levels in maternal gingival crevicular fluid levels between the three groups
6 months

Collaborators and Investigators

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

Sponsor

Hacer Sahin Aydinyurt

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)

February 2, 2015

Primary Completion (Actual)

August 15, 2016

Study Completion (Actual)

December 31, 2016

Study Registration Dates

First Submitted

February 16, 2017

First Submitted That Met QC Criteria

March 22, 2017

First Posted (Actual)

March 23, 2017

Study Record Updates

Last Update Posted (Actual)

September 28, 2017

Last Update Submitted That Met QC Criteria

September 26, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015-HIZ-DF306

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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