Evaluation of the Possible Relationship Between Periodontal Disease and Preterm Labor

• Conditions: Preterm Labor; Periodontal Disease
• Interventions: Diagnostic Test: preterm labor; Diagnostic Test: healthy

• Registration Number: NCT03610841
• Lead Sponsor: Recep Tayyip Erdogan University Training and Research Hospital

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.

Study Timeline

• Study Start: 2018-02-17
• Status Verified: 2018-07
• Study First Submitted: 2018-07-17
• Study First Submitted QC: 2018-07-31
• Last Update Submitted: 2018-07-31
• Study First Posted: 2018-08-01
• Last Update Posted: 2018-08-01
• Primary Completion: 2018-09-17
• Study Completion: 2018-12-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
healthy	preterm labor	24-36 6/7 weeks of pregnant between the age of 21 and 34
healthy	healthy	24-36 6/7 weeks of pregnant between the age of 21 and 34
preterm labor	preterm labor	Workgroup consists of patients which diagnosed with preterm labor between the age of 21 and 34
preterm labor	healthy	Workgroup consists of patients which diagnosed with preterm labor between the age of 21 and 34

Primary Outcome Measures

Name	Time	Method
TNF-Alpha	1 day	TNF-Alpha levels will be evaluated in salivary, serum and placenta samples using ELISA test Normal value:42-203pg/ml
prostaglandin E2	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	1 day	IL-1beta levels will be evaluated in salivary, serum and placenta samples using ELISA test Normal value:3-227pg/ml

Secondary Outcome Measures

Name	Time	Method
Porphyromonas gingivalis	1 Day	Presence of Porphyromonas gingivalis will be checked by rPCR method. Score 1: Present Score 2: None
Tannerella Forsythia	1 Day	Presence of Tannerella Forsythia will be checked by rPCR method. Score:1 Present. Score 2: None

Trial Locations

Locations (6)

İzmir Health Sciences University, Tepecik Training and Research Hospital Department of Obstetrics and Gynecology; 🇹🇷 İzmir, Turkey

Ege University Dentistry Faculty; 🇹🇷 İzmir, Turkey

Glaskow Dental School , School of Medicine University of Glasgow; 🇬🇧 Glaskow, United Kingdom

Recep Tayyip Erdogan University Dentistry Faculty; 🇹🇷 Rize, Turkey

Recep Tayyip Erdogan University Faculty of Medicine; 🇹🇷 Rize, Turkey

Recep Tayyip Erdogan University; 🇹🇷 Rize, Turkey