Association of Periodontitis and Preeclampsia During Pregnancy

Preeclampsia Clinical Trial

Official title:

Role of Cytokines in Association Between Periodontitis and Preeclampsia During Pregnancy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00855504
• Other study ID #: 34-499/2008(SR)
• Status: Completed
• Phase: N/A
• First received: March 2, 2009
• Last updated: April 10, 2015
• Start date: February 2009
• Est. completion date: January 2012

Study information

• Verified date: April 2015
• Source: Maulana Azad Medical College
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

Infections affecting the mother during pregnancy may produce alterations in the normal cytokine and hormone-regulated gestation, which could result in preeclampsia, preterm labor, premature rupture of membranes, and preterm birth. Therefore, pregnant women with periodontal disease may show an alteration in the cytokine levels which may cause preeclampsia in them.

Description:

The enrolled subjects will be evaluated on the basis of a pre-designed and pre-tested proforma with respect to history and clinical examination, obstetrics examination and ultrasonography. The periodontal examination consists of assessments at vestibular, lingual, mesial and distal sites of all present teeth.Five ml venous blood sample will be drawn from the patient at the time of enrollment before 20 weeks of gestation for the levels of cytokines (IL-4, IL-10, IFN-g and TNF-α. All the subjects will be followed- up till delivery. At the time of delivery, the details of pregnancy outcome (maternal and fetal) along with the measurement of the blood pressure will be recorded. A repeat of oral health evaluation will be done within 48 hours of delivery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 528
• Est. completion date: January 2012
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

• Singleton live pregnancy.

• Sure of her dates. (known dates of the last menstrual period)

• Age group 18-35 years.

Exclusion Criteria:

• Chronic hypertension

• Polyhydramnios

• Congenital malformation in fetus

• Diabetes

• Renal disease

• Cardiovascular disease

• Urolithiasis

• Parathyroid disease

• Systolic blood pressure measurement of more than 140mm Hg and diastolic blood pressure more than 90 mm Hg at first visit.

• Infections (bacterial vaginosis and chorioamnionitis)

• Antibiotic use during pregnancy

• Excessive body mass index

• Less than 20 natural teeth

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Gingival Diseases
• Periodontal Disease
• Periodontal Diseases
• Periodontitis
• Pre-Eclampsia
• Preeclampsia

Locations

Country	Name	City	State
India	Maulana Azad Medical College and Lok Nayak Hospital and Maulana Azad Institute of Dental Sciences	New Delhi	Delhi

Sponsors (2)

Lead Sponsor	Collaborator
Maulana Azad Medical College	University Grants Commission, New Delhi

Country where clinical trial is conducted

India, 

References & Publications (3)

Canakci V, Canakci CF, Canakci H, Canakci E, Cicek Y, Ingec M, Ozgoz M, Demir T, Dilsiz A, Yagiz H. Periodontal disease as a risk factor for pre-eclampsia: a case control study. Aust N Z J Obstet Gynaecol. 2004 Dec;44(6):568-73. — View Citation

Contreras A, Herrera JA, Soto JE, Arce RM, Jaramillo A, Botero JE. Periodontitis is associated with preeclampsia in pregnant women. J Periodontol. 2006 Feb;77(2):182-8. — View Citation

Cota LO, Guimarães AN, Costa JE, Lorentz TC, Costa FO. Association between maternal periodontitis and an increased risk of preeclampsia. J Periodontol. 2006 Dec;77(12):2063-9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Association between preeclampsia and periodontal disease and its correlation with the variation in cytokine levels.		3 years	No
Secondary	Correlation of relationship of periodontal disease with preeclampsia and pregnancy outcome.		3 years	No