Association of Periodontitis and Preeclampsia During Pregnancy

NCT00855504 | Completed

• 1 other identifier: 34-499/2008(SR)
• Study Type: observational
• Target: 528
• Locations: 1 country
• Sites: 1

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.

Conditions

Preeclampsia; Periodontal Disease

Keywords

preeclampsia; periodontitis; cytokines

Outcome Measures

Primary Outcomes (1)

• Association between preeclampsia and periodontal disease and its correlation with the variation in cytokine levels.

  3 years

Secondary Outcomes (1)

• Correlation of relationship of periodontal disease with preeclampsia and pregnancy outcome.

  3 years

Study Arms (1)

Subjects

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

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

primigravidae women with 14-20 weeks of gestation.

You may qualify if:

• Singleton live pregnancy.
• Sure of her dates. (known dates of the last menstrual period)
• Age group 18-35 years.

You may not qualify if:

• 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

Sponsors & Collaborators

• Maulana Azad Medical College: lead
• University Grants Commission, New Delhi: collaborator

Study Sites (1)

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

New Delhi, National Capital Territory of Delhi, 110002, India

Location

Related Publications (3)

• 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.

  PMID: 17209792 BACKGROUND

• 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.

  PMID: 16460242 BACKGROUND

• 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.

  PMID: 15598299 BACKGROUND

MeSH Terms

Conditions

Pre-Eclampsia; Periodontal Diseases; Periodontitis

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Ashok Kumar, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director Professor

Study Record Dates

• First Submitted: March 2, 2009
• First Posted: March 4, 2009
• Study Start: February 1, 2009
• Primary Completion: September 1, 2011
• Study Completion: January 1, 2012
• Last Updated: April 13, 2015

Record last verified: 2015-04

Locations

IN (1)