Association of Periodontitis and Preeclampsia During Pregnancy

Study Overview
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Brief Summary
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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
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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.

Official Title
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Role of Cytokines in Association Between Periodontitis and Preeclampsia During Pregnancy

Conditions
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Preeclampsia, Periodontal Disease

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Subjects<br>All the consecutive primigravidae who register in the antenatal clinic before 20 weeks of gestation | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Association between preeclampsia and periodontal disease and its correlation with the variation in cytokine levels. |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of relationship of periodontal disease with preeclampsia and pregnancy outcome. |  | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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preeclampsia, periodontitis, cytokines