Association of Periodontitis and Preeclampsia During Pregnancy

Role of Cytokines in Association Between Periodontitis and Preeclampsia During Pregnancy

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00855504

Enrollment

528

Registered

2009-03-04

Start date

2009-02-28

Completion date

2012-01-31

Last updated

2015-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Periodontal Disease, Preeclampsia

Keywords

preeclampsia, periodontitis, cytokines

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 35 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
Correlation of relationship of periodontal disease with preeclampsia and pregnancy outcome.	3 years

Countries

India

Outcome results