Association of Periodontitis and Preeclampsia During Pregnancy

This study has been completed.

Sponsor:

Collaborator:

University Grants Commission, New Delhi

Information provided by (Responsible Party):

Ashok Kumar, Maulana Azad Medical College

ClinicalTrials.gov Identifier:

NCT00855504

First received: March 2, 2009

Last updated: April 10, 2015

Last verified: April 2015

History of Changes

Purpose

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.

Condition
Preeclampsia Periodontal Disease


Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Role of Cytokines in Association Between Periodontitis and Preeclampsia During Pregnancy

Resource links provided by NLM:

Genetics Home Reference related topics: preeclampsia

MedlinePlus related topics: Gum Disease

Genetic and Rare Diseases Information Center resources: Eclampsia

U.S. FDA Resources

Further study details as provided by Maulana Azad Medical College:

Primary Outcome Measures:

Association between preeclampsia and periodontal disease and its correlation with the variation in cytokine levels. [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Correlation of relationship of periodontal disease with preeclampsia and pregnancy outcome. [ Time Frame: 3 years ] [ Designated as safety issue: No ]


Enrollment:	528
Study Start Date:	February 2009
Study Completion Date:	January 2012
Primary Completion Date:	September 2011 (Final data collection date for primary outcome measure)

Groups/Cohorts
Subjects All the consecutive primigravidae who register in the antenatal clinic before 20 weeks of gestation

Detailed 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.

Eligibility


Ages Eligible for Study:	18 Years to 35 Years (Adult)
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

primigravidae women with 14-20 weeks of gestation.

Criteria

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00855504

Locations


India
Maulana Azad Medical College and Lok Nayak Hospital and Maulana Azad Institute of Dental Sciences
New Delhi, Delhi, India, 110002

Sponsors and Collaborators

Maulana Azad Medical College

University Grants Commission, New Delhi

Investigators


Principal Investigator:	Ashok Kumar, MD	Department of Obstetrics and Gynecology, Maulana Azad Medical College, New Delhi, India

More Information

Publications:

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.

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.

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.


Responsible Party:	Ashok Kumar, Director Professor, Maulana Azad Medical College
ClinicalTrials.gov Identifier:	NCT00855504 History of Changes
Other Study ID Numbers:	34-499/2008(SR)
Study First Received:	March 2, 2009
Last Updated:	April 10, 2015
Health Authority:	India: Institutional Review Board

Keywords provided by Maulana Azad Medical College:


preeclampsia periodontitis cytokines

Additional relevant MeSH terms:


Periodontitis Pre-Eclampsia Periodontal Diseases Gingival Diseases	Mouth Diseases Stomatognathic Diseases Hypertension, Pregnancy-Induced Pregnancy Complications

ClinicalTrials.gov processed this record on September 23, 2016

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