Association of Periodontitis and Preeclampsia During Pregnancy

M

Maulana Azad Medical College

Status

Completed

Conditions

Preeclampsia
Periodontal Disease

Study type

Observational

Funder types

Other

Identifiers

NCT00855504
34-499/2008(SR)

Details and patient eligibility

About

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.

Full 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.

Enrollment

528 patients

Sex

Female

Ages

18 to 35 years old

Volunteers

No 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

Trial design

528 participants in 1 patient group

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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