Clinical trial NCT03610841: Evaluation of the Possible Relationship Between Periodontal Disease and Preterm Labor
Official title: Evaluation of the Possible Relationship Between Preterm Labor and Periodontal Disease With Clinical Periodontal, Biochemical and Microbiological Data
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Preterm Labor
Periodontal Disease
Lead sponsor: Recep Tayyip Erdogan University Training and Research Hospital
Sponsor class: OTHER
Collaborators: name: Ege University
First posted: 2018-08-01
Enrollment: 100
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 34
Standard ages: ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

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

Primary outcomes:
measure: prostaglandin E2
timeFrame: 1 Day
measure: TNF-Alpha
timeFrame: 1 day
measure: IL-1beta
timeFrame: 1 day
Secondary outcomes:
measure: Porphyromonas gingivalis
timeFrame: 1 Day
measure: Tannerella Forsythia
timeFrame: 1 Day
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Ege University Dentistry Faculty
city: İzmir
country: Turkey
facility: İzmir Health Sciences University, Tepecik Training and Research Hospital Department of Obstetrics and Gynecology
city: Rize
country: Turkey
facility: Recep Tayyip Erdogan University Dentistry Faculty
city: Rize
country: Turkey
facility: Recep Tayyip Erdogan University Faculty of Medicine
city: Rize
country: Turkey
facility: Recep Tayyip Erdogan University
city: Glaskow
country: United Kingdom
facility: Glaskow Dental School , School of Medicine University of Glasgow
Study officials:
References:
citation: 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.