Ignite Creation Date:
2025-12-24 @ 9:09 PM
Ignite Modification Date:
2025-12-31 @ 8:24 AM
Study NCT ID:
NCT00855504
Status:
COMPLETED
Last Update Posted:
2015-04-13
First Post:
2009-03-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Association of Periodontitis and Preeclampsia During Pregnancy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011225', 'term': 'Pre-Eclampsia'}, {'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D010518', 'term': 'Periodontitis'}], 'ancestors': [{'id': 'D046110', 'term': 'Hypertension, Pregnancy-Induced'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 528}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-10', 'studyFirstSubmitDate': '2009-03-02', 'studyFirstSubmitQcDate': '2009-03-03', 'lastUpdatePostDateStruct': {'date': '2015-04-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-03-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Association between preeclampsia and periodontal disease and its correlation with the variation in cytokine levels.', 'timeFrame': '3 years'}], 'secondaryOutcomes': [{'measure': 'Correlation of relationship of periodontal disease with preeclampsia and pregnancy outcome.', 'timeFrame': '3 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['preeclampsia', 'periodontitis', 'cytokines'], 'conditions': ['Preeclampsia', 'Periodontal Disease']}, 'referencesModule': {'references': [{'pmid': '17209792', 'type': 'BACKGROUND', '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.'}, {'pmid': '16460242', 'type': 'BACKGROUND', '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.'}, {'pmid': '15598299', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'primigravidae women with 14-20 weeks of gestation.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Singleton live pregnancy.\n* Sure of her dates. (known dates of the last menstrual period)\n* Age group 18-35 years.\n\nExclusion Criteria:\n\n* Chronic hypertension\n* Polyhydramnios\n* Congenital malformation in fetus\n* Diabetes\n* Renal disease\n* Cardiovascular disease\n* Urolithiasis\n* Parathyroid disease\n* Systolic blood pressure measurement of more than 140mm Hg and diastolic blood pressure more than 90 mm Hg at first visit.\n* Infections (bacterial vaginosis and chorioamnionitis)\n* Antibiotic use during pregnancy\n* Excessive body mass index\n* Less than 20 natural teeth'}, 'identificationModule': {'nctId': 'NCT00855504', 'briefTitle': 'Association of Periodontitis and Preeclampsia During Pregnancy', 'organization': {'class': 'OTHER', 'fullName': 'Maulana Azad Medical College'}, 'officialTitle': 'Role of Cytokines in Association Between Periodontitis and Preeclampsia During Pregnancy', 'orgStudyIdInfo': {'id': '34-499/2008(SR)'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Subjects', 'description': 'All the consecutive primigravidae who register in the antenatal clinic before 20 weeks of gestation'}]}, 'contactsLocationsModule': {'locations': [{'zip': '110002', 'city': 'New Delhi', 'state': 'National Capital Territory of Delhi', 'country': 'India', 'facility': 'Maulana Azad Medical College and Lok Nayak Hospital and Maulana Azad Institute of Dental Sciences', 'geoPoint': {'lat': 28.62137, 'lon': 77.2148}}], 'overallOfficials': [{'name': 'Ashok Kumar, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Obstetrics and Gynecology, Maulana Azad Medical College, New Delhi, India'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maulana Azad Medical College', 'class': 'OTHER'}, 'collaborators': [{'name': 'University Grants Commission, New Delhi', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director Professor', 'investigatorFullName': 'Ashok Kumar', 'investigatorAffiliation': 'Maulana Azad Medical College'}}}}