Association of Periodontitis and Preeclampsia During Pregnancy

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.

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Key information

Conditions

Preeclampsia Female Urogenital Diseases and Pregnancy Complications Hypertension, Pregnancy-Induced Mouth Diseases Periodontal Disease Periodontal Diseases Periodontitis Pre-Eclampsia Pregnancy Complications Stomatognathic Diseases Urogenital Diseases

Age range

18 year–35 year

Sex eligibility

Female

Study type

Observational

Primary location

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

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

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

Time frame: 3 years

Secondary outcomes

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

Time frame: 3 years

Sponsors and collaborators

Lead sponsor

Maulana Azad Medical College

Other

Collaborators

University Grants Commission, New Delhi

Registry information

Official study title

Role of Cytokines in Association Between Periodontitis and Preeclampsia During Pregnancy

Important dates

Study start: 2009
Primary completion: 2011
Study completion: 2012
First posted: Mar 4, 2009
Registry last updated: Apr 13, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed