Periodontal Status and Pregnancy or Delivery Complications in Type 1 Diabetes Mellitus Pregnant Women: a Case-control Study From Slovenia
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Periodontal Diseases
- Sponsor
- University of Ljubljana
- Enrollment
- 30
- Primary Endpoint
- Number of Pre-term births GWOB (Gestational week of birth) ≤ 37th week
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •Former smokers who had stopped smoking less than five years before participation
- •Pregnant women with other systemic diseases
Outcomes
Primary Outcomes
Number of Pre-term births GWOB (Gestational week of birth) ≤ 37th week
Time Frame: Day of delivery
Yes/No
Birth weight
Time Frame: Day of delivery
Weight in kg
Number of Delivery and/or Pregnancy complications
Time Frame: Day of delivery
Yes/No
Number of pregnant women with Pre-eclampsia
Time Frame: Between 28th and 34th week of gestation
Yes/No
GWOB - Gestational week of birth
Time Frame: Day of delivery
Week number
Number of C-section
Time Frame: Day of delivery
Yes/No
Number of pregnant women with Periodontal disease
Time Frame: Between 28th and 34th week of gestation
Yes/No
number of Births with weight ≤ 2500 g
Time Frame: Day of delivery
Yes/No
Secondary Outcomes
- 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)