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Association of Periodontitis and Preeclampsia During Pregnancy

This study is currently recruiting participants.
Verified July 2011 by Maulana Azad Medical College
Sponsor:
Collaborator:
University Grants Commission, New Delhi
Information provided by:
Maulana Azad Medical College
ClinicalTrials.gov Identifier:
NCT00855504
First received: March 2, 2009
Last updated: July 20, 2011
Last verified: July 2011
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

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 ]

Estimated Enrollment: 550
Study Start Date: February 2009
Estimated Study Completion Date: January 2012
Estimated 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
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00855504

Contacts
Contact: Ashok Kumar, MD 91-11-23232400 ext 4400 ash64kr@yahoo.com

Locations
India
Maulana Azad Medical College and Lok Nayak Hospital and Maulana Azad Institute of Dental Sciences Recruiting
New Delhi, Delhi, India, 110002
Contact: Ashok Kumar, MD     91-11-23232400 ext 4400     ash64kr@yahoo.com    
Principal Investigator: Ashok Kumar, MD            
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:

Responsible Party: Professor Ashok Kumar, Department of Obstetrics and Gynecology, 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: July 20, 2011
Health Authority: India: Institutional Review Board

Keywords provided by Maulana Azad Medical College:
preeclampsia
periodontitis
cytokines

Additional relevant MeSH terms:
Periodontal Diseases
Periodontitis
Pre-Eclampsia
Mouth Diseases
 Stomatognathic Diseases
Hypertension, Pregnancy-Induced
Pregnancy Complications

ClinicalTrials.gov processed this record on June 18, 2013