NCT03610841

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.

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2018

Shorter than P25 for all trials

Geographic Reach
2 countries

6 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 17, 2018

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 17, 2018

Completed
15 days until next milestone

First Posted

Study publicly available on registry

August 1, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 17, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2018

Completed
Last Updated

August 1, 2018

Status Verified

July 1, 2018

Enrollment Period

7 months

First QC Date

July 17, 2018

Last Update Submit

July 31, 2018

Conditions

Preterm LaborPeriodontal Disease

Outcome Measures

Primary Outcomes (3)

  • 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

Secondary Outcomes (2)

  • Porphyromonas gingivalis

    1 Day

  • Tannerella Forsythia

    1 Day

Study Arms (2)

preterm labor

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

Diagnostic Test: preterm laborDiagnostic Test: healthy

healthy

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

Diagnostic Test: preterm laborDiagnostic Test: healthy

Interventions

preterm laborDIAGNOSTIC_TEST

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

Also known as: blood sample, urine test
healthypreterm labor
healthyDIAGNOSTIC_TEST

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

Also known as: blood sample, urine test
healthypreterm labor

Eligibility Criteria

Age21 Years - 34 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailspregnant women
Age GroupsAdult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • pregnant women with preterm labor
  • \. weeks of pregnant women with no history of preterm labor

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Ege University Dentistry Faculty

Izmir, Turkey (Türkiye)

RECRUITING

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

Izmir, Turkey (Türkiye)

RECRUITING

Recep Tayyip Erdogan University Dentistry Faculty

Rize, 53000, Turkey (Türkiye)

ACTIVE NOT RECRUITING

Recep Tayyip Erdogan University Faculty of Medicine

Rize, 53000, Turkey (Türkiye)

ACTIVE NOT RECRUITING

Recep Tayyip Erdogan University

Rize, 53000, Turkey (Türkiye)

ACTIVE NOT RECRUITING

Glaskow Dental School , School of Medicine University of Glasgow

Glaskow, United Kingdom

ACTIVE NOT RECRUITING

Related Publications (1)

  • 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.

    PMID: 28282773BACKGROUND

Related Links

Biospecimen

Retention: SAMPLES WITHOUT DNA

Tissue samples from four centers will be taken from the maternal and fetal surfaces of the placenta Saliva samples of pregnant women

MeSH Terms

Conditions

Obstetric Labor, PrematurePeriodontal Diseases

Interventions

Blood Specimen CollectionUrinalysisDiet, Healthy

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative TechniquesClinical Chemistry TestsDiagnostic Techniques, UrologicalDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Central Study Contacts

Gül Yıldız Telatar, Dr.

CONTACT

05365404555gulyildiz@gmail.com

Beril Gürlek, Dr.

CONTACT

05535979403berilsem@yahoo.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 17, 2018

First Posted

August 1, 2018

Study Start

February 17, 2018

Primary Completion

September 17, 2018

Study Completion

December 15, 2018

Last Updated

August 1, 2018

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will not share

Data will be available within 6 months of study completion

Locations

TU(5)GB(1)