Evaluation of the Possible Relationship Between Periodontal Disease and Preterm Labor

NCT ID: NCT03610841

Last Updated: 2018-08-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-02-17

Study Completion Date

2018-12-15

Brief Summary

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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

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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.

Conditions

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Preterm Labor Periodontal Disease

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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preterm labor

Workgroup consists of patients which diagnosed with preterm labor between the age of 21 and 34

preterm labor

Intervention Type DIAGNOSTIC_TEST

liver function tests, kidney function tests and platelets measures the ratio of protein to creatinine

healthy

Intervention Type DIAGNOSTIC_TEST

liver function tests, kidney function tests and platelets measures the ratio of protein to creatinine

healthy

24-36 6/7 weeks of pregnant between the age of 21 and 34

preterm labor

Intervention Type DIAGNOSTIC_TEST

liver function tests, kidney function tests and platelets measures the ratio of protein to creatinine

healthy

Intervention Type DIAGNOSTIC_TEST

liver function tests, kidney function tests and platelets measures the ratio of protein to creatinine

Interventions

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preterm labor

liver function tests, kidney function tests and platelets measures the ratio of protein to creatinine

Intervention Type DIAGNOSTIC_TEST

healthy

liver function tests, kidney function tests and platelets measures the ratio of protein to creatinine

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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blood sample, urine test blood sample, urine test

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

34 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Ege University

OTHER

Sponsor Role collaborator

Recep Tayyip Erdogan University Training and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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Gul Yildiz Telatar

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ege University Dentistry Faculty

Izmir, , Turkey (Türkiye)

Site Status RECRUITING

İzmir Health Sciences University, Tepecik Training and Research Hospital Department of Obstetrics and Gynecology

Izmir, , Turkey (Türkiye)

Site Status RECRUITING

Recep Tayyip Erdogan University Dentistry Faculty

Rize, , Turkey (Türkiye)

Site Status ACTIVE_NOT_RECRUITING

Recep Tayyip Erdogan University Faculty of Medicine

Rize, , Turkey (Türkiye)

Site Status ACTIVE_NOT_RECRUITING

Recep Tayyip Erdogan University

Rize, , Turkey (Türkiye)

Site Status ACTIVE_NOT_RECRUITING

Glaskow Dental School , School of Medicine University of Glasgow

Glaskow, , United Kingdom

Site Status ACTIVE_NOT_RECRUITING

Countries

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Turkey (Türkiye) United Kingdom

Central Contacts

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Gül Yıldız Telatar, Dr.

Role: CONTACT

05365404555

Beril Gürlek, Dr.

Role: CONTACT

05535979403

Facility Contacts

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: Nurcan Buduneli, Prof. Dr.

Role: primary

05326962525

Önder Gürlek, Dr.

Role: backup

05057555888

Murat Alan, Dr.

Role: primary

05333952097

References

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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.

Reference Type BACKGROUND
PMID: 28282773 (View on PubMed)

Related Links

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http://www.ncbi.nlm.nih.gov/pubmed/28282773

Association of periodontitis with preterm birth and low birth weight

Other Identifiers

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40465587-26

Identifier Type: -

Identifier Source: org_study_id

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