Association of Periodontitis and Preeclampsia During Pregnancy

NCT ID: NCT00855504

Last Updated: 2015-04-13

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 528 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-02-28
• Study Completion Date: 2012-01-31

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.

Conditions

Preeclampsia; Periodontal Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Subjects

All the consecutive primigravidae who register in the antenatal clinic before 20 weeks of gestation

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University Grants Commission, New Delhi

UNKNOWN

Sponsor Role: collaborator

Maulana Azad Medical College

OTHER

Sponsor Role: lead

Responsible Party

Ashok Kumar

Director Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ashok Kumar, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Obstetrics and Gynecology, Maulana Azad Medical College, New Delhi, India

Locations

Maulana Azad Medical College and Lok Nayak Hospital and Maulana Azad Institute of Dental Sciences

New Delhi, National Capital Territory of Delhi, India

Countries

India

References

Cota LO, Guimaraes AN, Costa JE, Lorentz TC, Costa FO. Association between maternal periodontitis and an increased risk of preeclampsia. J Periodontol. 2006 Dec;77(12):2063-9. doi: 10.1902/jop.2006.060061.

Reference Type: BACKGROUND

PMID: 17209792 (View on PubMed)

Contreras A, Herrera JA, Soto JE, Arce RM, Jaramillo A, Botero JE. Periodontitis is associated with preeclampsia in pregnant women. J Periodontol. 2006 Feb;77(2):182-8. doi: 10.1902/jop.2006.050020.

Reference Type: BACKGROUND

PMID: 16460242 (View on PubMed)

Canakci V, Canakci CF, Canakci H, Canakci E, Cicek Y, Ingec M, Ozgoz M, Demir T, Dilsiz A, Yagiz H. Periodontal disease as a risk factor for pre-eclampsia: a case control study. Aust N Z J Obstet Gynaecol. 2004 Dec;44(6):568-73. doi: 10.1111/j.1479-828X.2004.00323.x.

Reference Type: BACKGROUND

PMID: 15598299 (View on PubMed)

Other Identifiers

34-499/2008(SR)

Identifier Type: -

Identifier Source: org_study_id