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Association of Periodontitis and Preeclampsia During Pregnancy

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ClinicalTrials.gov Identifier: NCT00855504
Recruitment Status : Completed
First Posted : March 4, 2009
Last Update Posted : April 13, 2015
Sponsor:
Collaborator:
University Grants Commission, New Delhi
Information provided by (Responsible Party):
Ashok Kumar, Maulana Azad Medical College

March 2, 2009
March 4, 2009
April 13, 2015
February 2009
September 2011   (Final data collection date for primary outcome measure)
Association between preeclampsia and periodontal disease and its correlation with the variation in cytokine levels. [ Time Frame: 3 years ]
Same as current
Complete list of historical versions of study NCT00855504 on ClinicalTrials.gov Archive Site
Correlation of relationship of periodontal disease with preeclampsia and pregnancy outcome. [ Time Frame: 3 years ]
Same as current
Not Provided
Not Provided
 
Association of Periodontitis and Preeclampsia During Pregnancy
Role of Cytokines in Association Between Periodontitis and Preeclampsia During Pregnancy
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.
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.
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
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Probability Sample
primigravidae women with 14-20 weeks of gestation.
  • Preeclampsia
  • Periodontal Disease
Not Provided
Subjects
All the consecutive primigravidae who register in the antenatal clinic before 20 weeks of gestation

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
528
550
January 2012
September 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
18 Years to 35 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
India
 
 
NCT00855504
34-499/2008(SR)
No
Not Provided
Not Provided
Ashok Kumar, Maulana Azad Medical College
Maulana Azad Medical College
University Grants Commission, New Delhi
Principal Investigator: Ashok Kumar, MD Department of Obstetrics and Gynecology, Maulana Azad Medical College, New Delhi, India
Maulana Azad Medical College
April 2015