Preterm Labor Clinical Trial
Official title:
Evaluation of the Possible Relationship Between Preterm Labor and Periodontal Disease With Clinical Periodontal, Biochemical and Microbiological Data
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Recep Tayyip Erdogan University Training and Research Hospital | Ege University |
Turkey, United Kingdom,
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
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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