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Sponsors and Collaborators: |
Maulana Azad Medical College University Grants Commission, New Delhi |
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Information provided by: | Maulana Azad Medical College |
ClinicalTrials.gov Identifier: | NCT00855504 |
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 |
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Preeclampsia Periodontal Disease |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | Role of Cytokines in Association Between Periodontitis and Preeclampsia During Pregnancy |
Estimated Enrollment: | 550 |
Study Start Date: | February 2009 |
Estimated Study Completion Date: | January 2012 |
Estimated Primary Completion Date: | July 2011 (Final data collection date for primary outcome measure) |
Groups/Cohorts |
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Subjects
All the consecutive primigravidae who register in the antenatal clinic before 20 weeks of gestation
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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.
Ages Eligible for Study: | 18 Years to 35 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
primigravidae women with 14-20 weeks of gestation.
Inclusion Criteria:
Exclusion Criteria:
Contact: Ashok Kumar, MD | 91-11-23232400 ext 4400 | ash64kr@yahoo.com |
India, Delhi | |
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 |
Principal Investigator: | Ashok Kumar, MD | Department of Obstetrics and Gynecology, Maulana Azad Medical College, New Delhi, India |
Responsible Party: | Department of Obstetrics and Gynecology, Maulana Azad Medical College ( Professor Ashok Kumar ) |
Study ID Numbers: | 34-499/2008(SR) |
Study First Received: | March 2, 2009 |
Last Updated: | March 3, 2009 |
ClinicalTrials.gov Identifier: | NCT00855504 History of Changes |
Health Authority: | India: Institutional Review Board |
preeclampsia periodontitis cytokines |
Mouth Diseases Hypertension, Pregnancy-Induced Periodontal Diseases Pregnancy Complications Eclampsia |
Periodontitis Pre-Eclampsia Stomatognathic Diseases Preeclampsia Hypertension |
Mouth Diseases Hypertension, Pregnancy-Induced Periodontal Diseases Pregnancy Complications |
Periodontitis Pre-Eclampsia Stomatognathic Diseases |