Interleukin-1 Receptor Antagonist Gene Polymorphism and Adverse Pregnancy Outcome in Turkish Women

Periodontitis Clinical Trial

— IRAGPAAOITW  

Official title:

Interleukin-1 Receptor Antagonist Gene Polymorphism and Adverse Pregnancy Outcome in Turkish Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01812083
• Other study ID #: SelcukU
• Secondary ID: SUDHF1451
• Status: Completed
• Phase: N/A
• First received: March 13, 2013
• Last updated: March 14, 2013
• Start date: January 2004
• Est. completion date: February 2005

Study information

• Verified date: March 2013
• Source: Selcuk University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Observational

Clinical Trial 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.

Description:

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. Current/past tobacco user, alcohol abuse, history of high-risk gestation, hypertension, gestational diabetes, any systemic disease and placenta previa were the exclusion criteria for this study. Maternal, obstetric, and demographic factors such as maternal age, maternal education, regular prenatal care, genitourinary tract infections during pregnancy, total number of births, previous PLBW, and antibiotic use during the pregnancy period were also recorded.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 156
• Est. completion date: February 2005
• Est. primary completion date: June 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

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.

Exclusion Criteria:

Current/past tobacco user, alcohol abuse, history of high-risk gestation, hypertension, gestational diabetes, any systemic disease and placenta previa were the exclusion criteria for this study.

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Periodontitis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Selcuk University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Interleukin-1 receptor antagonist gene polymorphism and adverse pregnancy outcome in Turkish women		5 months	Yes