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

Completed

• Conditions: Periodontitis

• Registration Number: NCT01812083
• Lead Sponsor: Selcuk University

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.

Detailed 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.

Study Timeline

• Study Start: 2004-01
• Primary Completion: 2004-06
• Study Completion: 2005-02
• Status Verified: 2013-03
• Study First Submitted: 2013-03-13
• Study First Submitted QC: 2013-03-14
• Last Update Submitted: 2013-03-14
• Study First Posted: 2013-03-15
• Last Update Posted: 2013-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 156

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Interleukin-1 receptor antagonist gene polymorphism and adverse pregnancy outcome in Turkish women	5 months