Evaluation of the Possible Relationship Between Preeclampsia and Periodontal Disease

NCT03603236 | Unknown

• 1 other identifier: 40465587-28
• Study Type: observational
• Target: 100
• Locations: 2 countries
• Sites: 5

Brief Summary

The primary objective of the study is to assess the incidence and severity of the periodontal infection of patients with preeclampsia. The secondary objective of the study is to analyze the relationship between preeclampsia and periodontal infection, using clinical, biochemical and microbiological methods.

Conditions

Preeclampsia; Periodontal Disease

Outcome Measures

Primary Outcomes (3)

• prostaglandin E2

  prostaglandin E2 levels will be evaulated in salivary, serum and placenta samples using ELISA test Normal value:29-97 pg / ml

  1 Day

• TNF-Alpha (Tumor necrosis factor -Alpha)

  TNF-Alpha levels will be evaulated in salivary, serum and placenta samples using ELISA test Normal value:42-203pg/ml

  1 day

• IL-1beta (Interleukin 1 beta)

  IL-1beta levels will be evaulated 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)

preeclampsia

18-40 aged diagnosed with preeclampsia

Diagnostic Test: preeclampsia; Diagnostic Test: control

control

18- 40 aged healthy females over 37. weeks of pregnant with no history of preeclampsia

Diagnostic Test: preeclampsia; Diagnostic Test: control

Interventions

preeclampsia DIAGNOSTIC_TEST

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

Also known as: blood sample, urine test

control; preeclampsia

control DIAGNOSTIC_TEST

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

Also known as: blood sample, urine test

control; preeclampsia

Eligibility Criteria

• Age: 21 Years - 34 Years
• Gender Eligibility Details: pregnant women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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 preeclampsia between the age of 18 and 40. Control group consists of healthy females over 37. weeks of pregnant with no history of preeclampsia.

You may qualify if:

• pregnant women with preeclampsia
• \. 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

Sponsors & Collaborators

• Recep Tayyip Erdogan University Training and Research Hospital: lead
• Ege University: collaborator

Study Sites (5)

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

Glaskow Dental School , School of Medicine University of Glasgow

Glaskow, United Kingdom

ACTIVE NOT RECRUITING

Related Publications (1)

• Jaiman G, Nayak PA, Sharma S, Nagpal K. Maternal periodontal disease and preeclampsia in Jaipur population. J Indian Soc Periodontol. 2018 Jan-Feb;22(1):50-54. doi: 10.4103/jisp.jisp_363_15.

  PMID: 29568173 BACKGROUND

Related Links

• Maternal periodontal disease and preeclampsia in Jaipur population.

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

Pre-Eclampsia; Periodontal Diseases

Interventions

Blood Specimen Collection; Urinalysis

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Clinical Chemistry Tests; Diagnostic Techniques, Urological

Study Officials

• Gül Yıldız Telatar

  Recep Tayyip Erdogan University Dentistry Faculty

  PRINCIPAL INVESTIGATOR

• Önder Gürlek, Dr.

  Ege University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gül Yıldız Telatar, Dr.

CONTACT

05365404555; gulyildiz@gmail.com

Beril Gürlek, Dr.

CONTACT

05535979403; berilsem@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: July 27, 2018
• Study Start: February 17, 2018
• Primary Completion: September 17, 2018
• Study Completion: December 15, 2018
• Last Updated: July 27, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (4); GB (1)