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Clinical Trials/NCT00855504
NCT00855504
Completed
Not Applicable

Role of Cytokines in Association Between Periodontitis and Preeclampsia During Pregnancy

Maulana Azad Medical College1 site in 1 country528 target enrollmentFebruary 2009

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Preeclampsia
Sponsor
Maulana Azad Medical College
Enrollment
528
Locations
1
Primary Endpoint
Association between preeclampsia and periodontal disease and its correlation with the variation in cytokine levels.
Status
Completed
Last Updated
11 years ago

Overview

Brief 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.

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.

Registry
clinicaltrials.gov
Start Date
February 2009
End Date
January 2012
Last Updated
11 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ashok Kumar

Director Professor

Maulana Azad Medical College

Eligibility 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
  • 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

Outcomes

Primary Outcomes

Association between preeclampsia and periodontal disease and its correlation with the variation in cytokine levels.

Time Frame: 3 years

Secondary Outcomes

  • Correlation of relationship of periodontal disease with preeclampsia and pregnancy outcome.(3 years)

Study Sites (1)

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