Periodontal Status and Pregnancy or Delivery Complications in Type 1 Diabetes Mellitus Pregnant Women: a Case-control Study From Slovenia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 主要终点
- Number of Pre-term births GWOB (Gestational week of birth) ≤ 37th week
研究概览
简要总结
The results of contemporary studies suggest an association between inflammatory periodontal disease and pregnancy and delivery complications. The aim of this study was to assess the association between periodontal disease, clinical periodontal parameters and pregnancy or delivery complications in type 1 diabetes mellitus and non-diabetic pregnant women.
详细描述
The results of contemporary studies suggest an association between inflammatory periodontal disease and pregnancy and delivery complications. The aim of this study was to assess the association between periodontal disease, clinical periodontal parameters and pregnancy or delivery complications in type 1 diabetes mellitus and non-diabetic pregnant women. Methods: 15 type 1 diabetes mellitus and 15 non-diabetic primiparous women were enrolled in the prospective "case-control" study. Investigators compared periodontal status, levels of glycosylated haemoglobin (HbA1c), high sensitivity C-Reactive Protein (hs-CRP), gestational week of birth, birth weight of a newborn and pregnancy or delivery complications (C-section, pre-eclampsia) between the groups.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 45 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy Pregnant Women
- •Pregnant Women with Diabetes Mellitus type 1
- •Healthy Pregnant Women with signs of Periodontal Disease
- •Pregnant Women with Diabetes Mellitus type 1 and signs of Periodontal disease
排除标准
- •Former smokers who had stopped smoking less than five years before participation
- •Pregnant women with other systemic diseases
结局指标
主要结局
Number of Pre-term births GWOB (Gestational week of birth) ≤ 37th week
时间窗: Day of delivery
Yes/No
Birth weight
时间窗: Day of delivery
Weight in kg
Number of Delivery and/or Pregnancy complications
时间窗: Day of delivery
Yes/No
Number of pregnant women with Pre-eclampsia
时间窗: Between 28th and 34th week of gestation
Yes/No
GWOB - Gestational week of birth
时间窗: Day of delivery
Week number
Number of C-section
时间窗: Day of delivery
Yes/No
Number of pregnant women with Periodontal disease
时间窗: Between 28th and 34th week of gestation
Yes/No
number of Births with weight ≤ 2500 g
时间窗: Day of delivery
Yes/No
次要结局
- CAL (Clinical attachment loss)(Between 28th and 34th week of gestation)
- Percantage of HbA1C (Glycosylated haemoglobin)(Between 28th and 34th week of gestation)
- PPD (Probing pocket depth)(Between 28th and 34th week of gestation)
- TBPW area (Total bleeding periodontal wound)(Between 28th and 34th week of gestation)
- Age(Between 28th and 34th week of gestation)
- BMI (Body mass index)(Between 28th and 34th week of gestation)
- percantage of sites with BOP (Bleeding on probing)(Between 28th and 34th week of gestation)
- TPIB (Total periodontal inflammatory burden)(Between 28th and 34th week of gestation)