Clinical trial NCT00855504: Association of Periodontitis and Preeclampsia During Pregnancy
Official title: Role of Cytokines in Association Between Periodontitis and Preeclampsia During Pregnancy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Preeclampsia
Periodontal Disease
Keywords: preeclampsia
periodontitis
cytokines
Lead sponsor: Maulana Azad Medical College
Sponsor class: OTHER
Collaborators: name: University Grants Commission, New Delhi
First posted: 2009-03-04
Enrollment: 528
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: primigravidae women with 14-20 weeks of gestation.

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.

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

Primary outcomes:
measure: Association between preeclampsia and periodontal disease and its correlation with the variation in cytokine levels.
timeFrame: 3 years
Secondary outcomes:
measure: Correlation of relationship of periodontal disease with preeclampsia and pregnancy outcome.
timeFrame: 3 years
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Maulana Azad Medical College and Lok Nayak Hospital and Maulana Azad Institute of Dental Sciences
state: Delhi
Study officials:
affiliation: Department of Obstetrics and Gynecology, Maulana Azad Medical College, New Delhi, India
name: Ashok Kumar, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.