Evaluation of the Possible Relationship Between Periodontal Disease and Preterm Labor

July 31, 2018 updated by: Gul Yildiz Telatar, Recep Tayyip Erdogan University Training and Research Hospital

Evaluation of the Possible Relationship Between Preterm Labor and Periodontal Disease With Clinical Periodontal, Biochemical and Microbiological Data

The primary objective of the study is to assess the incidence and severity of the periodontal infection of patients with preterm labor.

The secondary objective of the study is to analyze the relationship between preterm labor and periodontal infection, using clinical, biochemical and microbiological methods.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Preterm infants are born prior to completion of 37 weeks of gestation. Periodontal disease is a subclinical and persistent infection source which induces the systemic inflammatory reactions and increases the risk of preterm labor. It is believed that the results will set light to the etiology of preterm labor and will help to develop strategies to prevent the disease.

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Rize, Turkey, 53000
        • Active, not recruiting
        • Recep Tayyip Erdogan University Dentistry Faculty
      • Rize, Turkey, 53000
        • Active, not recruiting
        • Recep Tayyip Erdogan University Faculty of Medicine
      • Rize, Turkey, 53000
        • Active, not recruiting
        • Recep Tayyip Erdogan University
      • İzmir, Turkey
        • Recruiting
        • Ege University Dentistry Faculty
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Pınar Gumus, Dr.
      • İzmir, Turkey
        • Recruiting
        • İzmir Health Sciences University, Tepecik Training and Research Hospital Department of Obstetrics and Gynecology
        • Contact:
  • United Kingdom
      • Glaskow, United Kingdom
        • Active, not recruiting
        • Glaskow Dental School , School of Medicine University of Glasgow

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

17 years to 30 years (Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

The study is planned to be a case-control study. Workgroup consists of 50 patients which diagnosed with preterm labor between the age of 21 and 34. Control group consists of healthy females 24-36 6/7 weeks of pregnant with no history of preterm labor.

Description

Inclusion Criteria:

  • pregnant women with preterm labor
  • 37. weeks of pregnant women with no history of preterm labor

Exclusion Criteria:

  • Genitourinary infection
  • pregnancy or pre-pregnancy hypertension
  • HIV infection
  • diabetes mellitus
  • multiple pregnancy, preterm labor / low birth weight
  • smoker and alcohol use history
  • IVF pregnancy
  • placental, cervical and uterine anomalies
  • pregnancy with intrauterine growth retardation
  • pregnancies with congenital or chromosomal fetal anomalies
  • significant vaginal bleeding
  • infertility stories
  • drug addicts
  • poor socioeconomic level

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

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
preterm labor
Workgroup consists of patients which diagnosed with preterm labor between the age of 21 and 34
Diagnostic test: preterm labor
liver function tests, kidney function tests and platelets measures the ratio of protein to creatinine
Other Names:
  • blood sample, urine test
Diagnostic test: healthy
liver function tests, kidney function tests and platelets measures the ratio of protein to creatinine
Other Names:
  • blood sample, urine test
healthy
24-36 6/7 weeks of pregnant between the age of 21 and 34
Diagnostic test: preterm labor
liver function tests, kidney function tests and platelets measures the ratio of protein to creatinine
Other Names:
  • blood sample, urine test
Diagnostic test: healthy
liver function tests, kidney function tests and platelets measures the ratio of protein to creatinine
Other Names:
  • blood sample, urine test

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
prostaglandin E2
Time Frame: 1 Day
prostaglandin E2 levels will be evaluated in salivary, serum and placenta samples using ELISA test Normal value:29-97 pg / ml
1 Day
TNF-Alpha
Time Frame: 1 day
TNF-Alpha levels will be evaluated in salivary, serum and placenta samples using ELISA test Normal value:42-203pg/ml
1 day
IL-1beta
Time Frame: 1 day
IL-1beta levels will be evaluated in salivary, serum and placenta samples using ELISA test Normal value:3-227pg/ml
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Porphyromonas gingivalis
Time Frame: 1 Day
Presence of Porphyromonas gingivalis will be checked by rPCR method. Score 1: Present Score 2: None
1 Day
Tannerella Forsythia
Time Frame: 1 Day
Presence of Tannerella Forsythia will be checked by rPCR method. Score:1 Present. Score 2: None
1 Day

Collaborators and Investigators

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

Sponsor

Recep Tayyip Erdogan University Training and Research Hospital

Collaborators

Ege University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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 17, 2018

Primary Completion (Anticipated)

September 17, 2018

Study Completion (Anticipated)

December 15, 2018

Study Registration Dates

First Submitted

July 17, 2018

First Submitted That Met QC Criteria

July 31, 2018

First Posted (Actual)

August 1, 2018

Study Record Updates

Last Update Posted (Actual)

August 1, 2018

Last Update Submitted That Met QC Criteria

July 31, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 40465587-26

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Data will be available within 6 months of study completion

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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