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Clinical Trials/NCT03610841
NCT03610841
Unknown
Not Applicable

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

Recep Tayyip Erdogan University Training and Research Hospital6 sites in 2 countries100 target enrollmentFebruary 17, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Preterm Labor
Sponsor
Recep Tayyip Erdogan University Training and Research Hospital
Enrollment
100
Locations
6
Primary Endpoint
TNF-Alpha
Last Updated
7 years ago

Overview

Brief Summary

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.

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.

Registry
clinicaltrials.gov
Start Date
February 17, 2018
End Date
December 15, 2018
Last Updated
7 years ago
Study Type
Observational
Sex
Female

Investigators

Sponsor
Recep Tayyip Erdogan University Training and Research Hospital
Responsible Party
Principal Investigator
Principal Investigator

Gul Yildiz Telatar

Principal Investigator

Recep Tayyip Erdogan University Training and Research Hospital

Eligibility Criteria

Inclusion Criteria

  • pregnant women with preterm labor
  • 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

Outcomes

Primary Outcomes

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

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

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

Secondary Outcomes

  • Porphyromonas gingivalis(1 Day)
  • Tannerella Forsythia(1 Day)

Study Sites (6)

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