NCT01812083

Brief Summary

The investigators hypothesized that the IL-1A (+4895), IL-1B (+3954), and IL-1RN gene polymorphisms may be associated with PLBW. Smoking has been well documented by numerous studies as a major environmental risk factor for periodontitis and adverse pregnancy outcomes. Therefore, the investigators only selected non-smoking individuals in this study as the smoking-related risk could obscure the polymorphism-related increase in risk for periodontitis and adverse pregnancy outcomes. This study aimed to determine the association between IL-1A (+4895), IL-1B (+3954), and IL-1RN polymorphisms with adverse pregnancy outcomes and periodontitis in a non-smoking Turkish population.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
156

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2004

Status
completed

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

January 1, 2004

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2004

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2005

Completed
8.1 years until next milestone

First Submitted

Initial submission to the registry

March 13, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 15, 2013

Completed
Last Updated

March 15, 2013

Status Verified

March 1, 2013

Enrollment Period

5 months

First QC Date

March 13, 2013

Last Update Submit

March 14, 2013

Conditions

Keywords

Periodontitis; adverse pregnancy outcomes; IL-1 polymorphism

Outcome Measures

Primary Outcomes (1)

  • Interleukin-1 receptor antagonist gene polymorphism and adverse pregnancy outcome in Turkish women

    5 months

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Pregnant women between 18-35 years of age with single gestation and with ≥20 on-crowded teeth excluding third molars were included in this study. Subjects were divided into normal birth (NB) and PLBW groups on the basis of their pregnancy outcome. Women who delivered an infant with a birth weight of more than 2500 g after 37 weeks of gestation were placed in the NB group. Women who delivered infants whose birth weight was below 2500 g or before 37 weeks of gestation were placed in the PLBW group.

You may qualify if:

  • Subjects were divided into normal birth (NB) and PLBW groups on the basis of their pregnancy outcome. Women who delivered an infant with a birth weight of more than 2500 g after 37 weeks of gestation were placed in the NB group.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Officials

  • Nilgün Özlem Alptekin, DDS,PhD,Prof

    Selcuk University Faculty of Dentistry

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dental Faculty

Study Record Dates

First Submitted

March 13, 2013

First Posted

March 15, 2013

Study Start

January 1, 2004

Primary Completion

June 1, 2004

Study Completion

February 1, 2005

Last Updated

March 15, 2013

Record last verified: 2013-03