Association of Periodontitis and Preeclampsia During Pregnancy

Completed

• Conditions: Preeclampsia; Periodontal Disease

• Registration Number: NCT00855504
• Lead Sponsor: Maulana Azad Medical College

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.

Study Timeline

• Study Start: 2009-02
• Study First Submitted: 2009-03-02
• Study First Submitted QC: 2009-03-03
• Study First Posted: 2009-03-04
• Primary Completion: 2011-09
• Study Completion: 2012-01
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-10
• Last Update Posted: 2015-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 528

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Association between preeclampsia and periodontal disease and its correlation with the variation in cytokine levels.	3 years

Secondary Outcome Measures

Name	Time	Method
Correlation of relationship of periodontal disease with preeclampsia and pregnancy outcome.	3 years

Trial Locations

Locations (1)

Maulana Azad Medical College and Lok Nayak Hospital and Maulana Azad Institute of Dental Sciences; 🇮🇳 New Delhi, Delhi, India