Evaluation of the Possible Relationship Between Periodontal Disease and Preterm Labor

Study 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.

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

Conditions
-----------------
Preterm Labor, Periodontal Disease

Intervention / Treatment
-----------------
* Diagnostic Test: preterm labor
* Diagnostic Test: healthy


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 34 Years

Sexes Eligible for Study
-----------------
Female

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| preterm labor<br>Workgroup consists of patients which diagnosed with preterm labor between the age of 21 and 34 | Diagnostic Test: preterm labor<br>* liver function tests, kidney function tests and platelets measures the ratio of protein to creatinine<br>* Other names: blood sample, urine test;Diagnostic Test: healthy<br>* liver function tests, kidney function tests and platelets measures the ratio of protein to creatinine<br>* Other names: blood sample, urine test;|
| healthy<br>24-36 6/7 weeks of pregnant between the age of 21 and 34 | Diagnostic Test: preterm labor<br>* liver function tests, kidney function tests and platelets measures the ratio of protein to creatinine<br>* Other names: blood sample, urine test;Diagnostic Test: healthy<br>* liver function tests, kidney function tests and platelets measures the ratio of protein to creatinine<br>* Other names: blood sample, urine test;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| prostaglandin E2 | 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 | TNF-Alpha levels will be evaluated in salivary, serum and placenta samples using ELISA test Normal value:42-203pg/ml | 1 day | 
| IL-1beta | 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 | Presence of Porphyromonas gingivalis will be checked by rPCR method. Score 1: Present Score 2: None | 1 Day | 
| Tannerella Forsythia | Presence of Tannerella Forsythia will be checked by rPCR method. Score:1 Present. Score 2: None | 1 Day |