Vaginal, Oral and Systemic Inflammation in Preterm Birth
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 71
- 试验地点
- 1
- 主要终点
- Difference in systemic and local parameters of infection between patients at risk and controls
研究概览
简要总结
The prevalence of preterm birth is not decreasing in the last decades despite of improving health care. Intrauterine infections are important in the etiology of preterm birth but the interconnection of systemic inflammation and preterm birth is not clear. Mechanisms of preterm birth should be assessed as preterm birth is the major risk factor for morbidity and mortality during birth, thus being important for the individual and regarding health costs.
No interventions will be carried out in this study.
Hypotheses:
- There is a common etiology between oral and vaginal inflammation
- Bacterial species are similar in vagina and oral cavity
- There are similar oral and systemic immune reactions which provoke preterm birth
- Inflammatory markers are found in pregnant women at risk and get back to normal post partum In this matched case control study of pregnant women local, systemic and oral inflammation markers and bacterial load are assessed to find out interconnections between these body compartments to allow for explanation of the etiology of preterm birth.
详细描述
Vaginal, oral and systemic inflammation in preterm birth
- Summary
The prevalence of preterm birth (PTB) is increasing. While intrauterine infections may be the primary cause of PTB, remote infections may also be part of the aetiology and risk for gestational complications. Predicting and identifying women at risk for delivering preterm is difficult. Comprehensive studies are needed to study all infectious and inflammatory processes that may be involved in birth complications. Social, ethnic and behavioural risks are part of the factors involved. Thus, case-control studies of infection in pregnancy must acknowledge and control for such other factors.
The oral cavity provides a unique study model of periodontal infection and inflammation. Gingivitis and periodontitis have been associated with an elevated risk for PTB. A large entity of bacteria including both aerobic and anaerobic bacteria competent to elicit a systemic hyper-inflammatory host immune response can be identified in periodontal infection. Inflammation of the gingival tissues increases in pregnancy. Knowledge obtained through studies of clinical parameters as well as studies of bacteria and cytokines in oral, vaginal and blood samples in pregnant women at risk for preterm birth would establish evidence-based background for successful clinical strategies to prevent or reduce the risk for PTB.
The objectives of the present matched case-control study of pregnant women are to investigate local and remote infection (microbiological analysis by culture, and DNA-DNA checkerboard) and inflammation (cytokine assays in samples from vaginal and oral samples), and routine clinical data in three groups of pregnant women:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnancy
- •Written informed consent
排除标准
- •Matching with control patients not possible
结局指标
主要结局
Difference in systemic and local parameters of infection between patients at risk and controls
时间窗: The study period is meant to be 2 years. Measures will be carried out during pregnancy, within 2 days after birth and 6 weeks post-partum.
Oral, vaginal and placental infection parameters are measured during pregnancy, at birth and 6 weeks post partum. Samples are collected from blood, vaginal and placental (at birth) smears, histology, and oral smears. Measures include microbiologic culturing, gram stains, CRP, Cytokines (TNFalpha, IL-1beta, IL-6, IL-8, IL-10, PgE2). From blood samples a differential blood count, CRP, and cytokines are determined.
次要结局
未报告次要终点