PreeclampsiaNCT00855504
Association of Periodontitis and Preeclampsia During Pregnancy
An observational study of Preeclampsia and Periodontal Disease, run by Maulana Azad Medical College at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Preeclampsia, Periodontal Disease
- How many people
- 528 participants
- Where
- 1 siteIndia
- Study dates
- Feb 2009to Jan 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- No healthy volunteers
- Adult
Study population: primigravidae women with 14-20 weeks of gestation.
Who may be able to join
- Singleton live pregnancy.
- Sure of her dates. (known dates of the last menstrual period)
- Age group 18-35 years.
Who cannot join
- Chronic hypertension
- Polyhydramnios
- Congenital malformation in fetus
- Diabetes
- Renal disease
- Cardiovascular disease
Show all 13Show fewer
- 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 locations and contacts
1 site in 1 country.
India1 site
Maulana Azad Medical College and Lok Nayak Hospital and Maulana Azad Institute of Dental Sciences
New Delhi, National Capital Territory of Delhi, 110002
About this study
Official title: Role of Cytokines in Association Between 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.
Read the 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
- Preeclampsia, Periodontal Disease
- Keywords
- preeclampsia, periodontitis, cytokines
- Medical subject headings
- Pre-Eclampsia, Periodontal Diseases, Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Subjects | All the consecutive primigravidae who register in the antenatal clinic before 20 weeks of gestation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Association between preeclampsia and periodontal disease and its correlation with the variation in cytokine levels.
Measured: 3 years
Secondary outcomes (1)
Correlation of relationship of periodontal disease with preeclampsia and pregnancy outcome.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2009 (estimated)
- Study startFeb 2009
- Primary completionSep 2011
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for PreeclampsiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 528 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maulana Azad Medical College
- Sponsor type
- University, hospital or other
- Collaborators
- University Grants Commission, New Delhi
- Responsible party
- Principal investigator, Ashok Kumar, Maulana Azad Medical College
- Investigators
- Ashok Kumar, MD, Principal investigator, Department of Obstetrics and Gynecology, Maulana Azad Medical College, New Delhi, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00855504
- Sponsor's protocol ID
- 34-499/2008(SR)
- Status last verified
- Apr 2015
- First submitted
- 2 Mar 2009
- Last updated
- 13 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 17209792Contreras 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.
PubMed 16460242Canakci 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.
PubMed 15598299
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Cytokines in Association Between Periodontitis and Preeclampsia During Pregnancy
- ClinicalTrials.gov ID
- NCT00855504
- Acronym / sponsor ID
- 34-499/2008(SR)
- Conditions
- Preeclampsia, Periodontal Disease
- Keywords
- preeclampsia, periodontitis, cytokines
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 528 participants (actual)
- Lead sponsor
- Maulana Azad Medical CollegeUniversity, hospital or other
- Collaborators
- University Grants Commission, New Delhi
- Study start
- Feb 2009
- Primary completion
- Sep 2011 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 4 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects | – | –All the consecutive primigravidae who register in the antenatal clinic before 20 weeks of gestation |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- primigravidae women with 14-20 weeks of gestation.
Key inclusion criteria (3 listed)
- Singleton live pregnancy.
- Sure of her dates. (known dates of the last menstrual period)
- Age group 18-35 years.
Key exclusion criteria (13 listed)
- Chronic hypertension
- Polyhydramnios
- Congenital malformation in fetus
- Diabetes
- Renal disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Association between preeclampsia and periodontal disease and its correlation with the variation in cytokine levels.
Time frame: 3 years
1 secondary outcome
Correlation of relationship of periodontal disease with preeclampsia and pregnancy outcome.
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2015.
- Background: PubMed 17209792Cota 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.
- Background: PubMed 16460242Contreras 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.
- Background: PubMed 15598299Canakci 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ashok Kumar, MD principal investigator
Department of Obstetrics and Gynecology, Maulana Azad Medical College, New Delhi, India
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Preeclampsia and Periodontal Disease, run by Maulana Azad Medical College at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association between preeclampsia and periodontal disease and its correlation with the variation in cytokine levels. (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00855504, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2015.