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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03603236
Other study ID # 40465587-28
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 17, 2018
Est. completion date December 15, 2018

Study information

Verified date July 2018
Source Recep Tayyip Erdogan University Training and Research Hospital
Contact Gül Yildiz Telatar, Dr.
Phone 05365404555
Email gulyildiz@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

Preeclampsia is identified as an important cause for mother and newborn mortality. Inspite of extensive research, the exact etiological relations have not been established.

Periodontal disease is a subclinical and persistent infection source which induces the systemic inflammatory reactions and increases the risk of preeclampsia. It is believed that the results will set light to the etiology of preeclampsia and will help to develop strategies to prevent the disease.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date December 15, 2018
Est. primary completion date September 17, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 21 Years to 34 Years
Eligibility Inclusion Criteria:

- pregnant women with preeclampsia

- 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

Study Design


Intervention

Diagnostic Test:
preeclampsia
liver function tests, kidney function tests and platelets measures the ratio of protein to creatinine
control
liver function tests, kidney function tests and platelets measures the ratio of protein to creatinine

Locations

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 Dentistry Faculty Rize
Turkey Recep Tayyip Erdogan University Faculty of Medicine Rize
United Kingdom Glaskow Dental School , School of Medicine University of Glasgow Glaskow

Sponsors (2)

Lead Sponsor Collaborator
Recep Tayyip Erdogan University Training and Research Hospital Ege University

Countries where clinical trial is conducted

Turkey,  United Kingdom, 

References & 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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 Porphyromonas gingivalis Presence of Porphyromonas gingivalis will be checked by rPCR method. Score 1: Present Score 2: None Tannerella Forsythia (+,-) 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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