Association of 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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Role of Cytokines in Association Between Periodontitis and Preeclampsia During Pregnancy|
- Association between preeclampsia and periodontal disease and its correlation with the variation in cytokine levels. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- Correlation of relationship of periodontal disease with preeclampsia and pregnancy outcome. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
|Study Start Date:||February 2009|
|Study Completion Date:||January 2012|
|Primary Completion Date:||September 2011 (Final data collection date for primary outcome measure)|
All the consecutive primigravidae who register in the antenatal clinic before 20 weeks of gestation
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00855504
|Maulana Azad Medical College and Lok Nayak Hospital and Maulana Azad Institute of Dental Sciences|
|New Delhi, Delhi, India, 110002|
|Principal Investigator:||Ashok Kumar, MD||Department of Obstetrics and Gynecology, Maulana Azad Medical College, New Delhi, India|