Trials / Completed
CompletedNCT00855504
Association of Periodontitis and Preeclampsia During Pregnancy
Role of Cytokines in Association Between Periodontitis and Preeclampsia During Pregnancy
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 528 (actual)
- Sponsor
- Maulana Azad Medical College · Academic / Other
- Sex
- Female
- Age
- 18 Years – 35 Years
- Healthy volunteers
- Not accepted
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
Timeline
- Start date
- 2009-02-01
- Primary completion
- 2011-09-01
- Completion
- 2012-01-01
- First posted
- 2009-03-04
- Last updated
- 2015-04-13
Locations
1 site across 1 country: India
Source: ClinicalTrials.gov record NCT00855504. Inclusion in this directory is not an endorsement.