NCT00582374

Brief Summary

To determine the relationship between periodontal disease and upper genital tract inflammation in pregnancy. To determine whether certain fluid levels in the oral cavity and the vagina are associated with preterm birth or low-birth weight.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2005

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2005

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

December 19, 2007

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 28, 2007

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
Last Updated

March 28, 2017

Status Verified

March 1, 2017

Enrollment Period

4 years

First QC Date

December 19, 2007

Last Update Submit

March 24, 2017

Conditions

Periodontal DiseasePreterm BirthLow Birth Weight

Keywords

Periodontal DiseasePreterm BirthLow Birth WeightPregnancy

Outcome Measures

Primary Outcomes (1)

  • To determine the relationship between periodontal disease and upper genital tract inflammation as measured by cytokine levels IL-6, IL-1, and TNF-α and MMP levels from the posterior fornix of the vagina.

    4 years

Secondary Outcomes (1)

  • To determine whether IL-1β levels in the oral cavity and the vagina are associated with preterm birth or low-birth weight.

    4 years

Study Arms (1)

A

Pregnant Women

Eligibility Criteria

Age15 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Pregnant women from the OU Medical Center Women's Clinic

You may qualify if:

  • Between the ages of 15-35
  • Singleton gestation

You may not qualify if:

  • Diabetes prior to pregnancy
  • Require antibiotic prophylaxis prior to dental treatment
  • Require steroids during pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

Biospecimen

Retention: NONE RETAINED

Gingival crevicular fluid (GCF) and Vaginal Fluid

MeSH Terms

Conditions

Periodontal DiseasesPremature Birth

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesObstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Eric Knudtson, MD

    University of Oklahoma

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 19, 2007

First Posted

December 28, 2007

Study Start

March 1, 2005

Primary Completion

March 1, 2009

Study Completion

March 1, 2009

Last Updated

March 28, 2017

Record last verified: 2017-03

Locations

US(1)