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NCT03610841 Clinical Trial

Evaluation of the Possible Relationship Between Periodontal Disease and Preterm Labor

Preterm Labor Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03610841
Other study ID # 40465587-26
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 17, 2018
Est. completion date December 15, 2018

Study information
Verified date July 2018
Source Recep Tayyip Erdogan University Training and Research Hospital
Contact Gül Yildiz Telatar, Dr.
Phone 05365404555
Email gulyildiz@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date December 15, 2018
Est. primary completion date September 17, 2018
Accepts healthy volunteers
Gender Female
Age group 21 Years to 34 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• preterm labor
liver function tests, kidney function tests and platelets measures the ratio of protein to creatinine
• healthy
liver function tests, kidney function tests and platelets measures the ratio of protein to creatinine

Locations
Country Name City State
Turkey Ege University Dentistry Faculty Izmir
Turkey Izmir Health Sciences University, Tepecik Training and Research Hospital Department of Obstetrics and Gynecology Izmir
Turkey Recep Tayyip Erdogan University Rize
Turkey Recep Tayyip Erdogan University Dentistry Faculty Rize
Turkey Recep Tayyip Erdogan University Faculty of Medicine Rize
United Kingdom Glaskow Dental School , School of Medicine University of Glasgow Glaskow

Sponsors (2)
Lead Sponsor Collaborator
Recep Tayyip Erdogan University Training and Research Hospital Ege University

Countries where clinical trial is conducted

Turkey,  United Kingdom, 

References & Publications (1)

Puertas A, Magan-Fernandez A, Blanc V, Revelles L, O'Valle F, Pozo E, León R, Mesa F. Association of periodontitis with preterm birth and low birth weight: a comprehensive review. J Matern Fetal Neonatal Med. 2018 Mar;31(5):597-602. doi: 10.1080/14767058.2017.1293023. Epub 2017 Feb 28. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary 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
Primary TNF-Alpha TNF-Alpha levels will be evaluated in salivary, serum and placenta samples using ELISA test Normal value:42-203pg/ml 1 day
Primary 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 Porphyromonas gingivalis Presence of Porphyromonas gingivalis will be checked by rPCR method. Score 1: Present Score 2: None 1 Day
Secondary Tannerella Forsythia Presence of Tannerella Forsythia will be checked by rPCR method. Score:1 Present. Score 2: None 1 Day
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Completed NCT02536352 - Effect of Supplementation of Fluoride on Maternal Periodontal Health, Preterm Delivery, and Perinatal Well-Being Early Phase 1
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Completed NCT03785795 - Multichannel EMG Diagnosing True Preterm Labor
Withdrawn NCT02351310 - Effectiveness of ACS in Extreme Preemies Phase 3
Not yet recruiting NCT01985594 - Utrogestan Versus Nifedipine as Tocolysis for Preterm Labor: a Randomised Controlled Trial Phase 2
Not yet recruiting NCT04532086 - Uterocervical Angle and Preterm Labour
Completed NCT04605172 - Lockdown Impact on Spontaneous Premature Birth in a Level III NICU
Recruiting NCT04417595 - Investigating N-3 Fatty Acids to Prevent Neonatal Tobacco-related outcomeS Phase 2
Completed NCT03923023 - Impact of the PREEMI Package on Neonatal Mortality
Recruiting NCT06157203 - Labor Status Monitor for Diagnosing True vs False Labor in Preterm Patients

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