NCT03610841|Unknown
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Sponsor study identifier
observational
100
2 countries
6
Study Start
February 17, 2018
Actual (reported)Primary Completion
September 17, 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 15, 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 15, 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 17, 2018
Actual (reported)July 17, 2018
Actual (reported)August 1, 2018
Actual (reported)September 17, 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 15, 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
Porphyromonas gingivalis
1 Day
Tannerella Forsythia
1 Day
Workgroup consists of patients which diagnosed with preterm labor between the age of 21 and 34
24-36 6/7 weeks of pregnant between the age of 21 and 34
liver function tests, kidney function tests and platelets measures the ratio of protein to creatinine
liver function tests, kidney function tests and platelets measures the ratio of protein to creatinine
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.
Ege University Dentistry Faculty
Izmir, Turkey (Türkiye)
İzmir Health Sciences University, Tepecik Training and Research Hospital Department of Obstetrics and Gynecology
Izmir, Turkey (Türkiye)
Puertas A, Magan-Fernandez A, Blanc V, Revelles L, O'Valle F, Pozo E, Leon 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.
Tissue samples from four centers will be taken from the maternal and fetal surfaces of the placenta Saliva samples of pregnant women
First Submitted
July 17, 2018
First Posted
August 1, 2018
Study Start
February 17, 2018
Actual (reported)Primary Completion
September 17, 2018
Estimated (date passed)Hepcidin Levels in Periodontal Health and Disease
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Recep Tayyip Erdogan University Dentistry Faculty
Rize, 53000, Turkey (Türkiye)
Recep Tayyip Erdogan University Faculty of Medicine
Rize, 53000, Turkey (Türkiye)
Recep Tayyip Erdogan University
Rize, 53000, Turkey (Türkiye)
Glaskow Dental School , School of Medicine University of Glasgow
Glaskow, United Kingdom
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 15, 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
August 1, 2018
Record last verified: 2018-07
Data will be available within 6 months of study completion
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Source: ClinicalTrials.gov.
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