Immunology in diabetic pregnancy.
- Conditions
- Immunological changes in diabetic pregnancy.
- Registration Number
- NL-OMON23378
- Lead Sponsor
- niversity Medical Centre Groningen
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 120
Inclusion Criteria
Group 1: Pregnant women with DM1 >18 en <40 yrs;
Group 2: Pregnant women with DM2 >18 en <40 yrs;
Exclusion Criteria
Group 1,2:
1. HbA1c >7,5% after 30 weeks of gestation;
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method In case of pregnancy, the peripheral immune response will be determined by taking venous blood samples (10 ml heparinised and 10 ml EDTA) in the third trimester of pregnancy. In case of non-pregnant women, the blood samples will be taken in the follicular phase of the ovarian cycle.<br><br /><br /><br>Local immune response: All placentas will be collected after delivery if approval has been obtained and biopsies will be taken in situ of the decidua. Thereby, tissue biopsies will be obtained from the placental bed from the uterus after delivery of the placenta during caesarean delivery.<br>
- Secondary Outcome Measures
Name Time Method To determine the maternal and foetal outcome of diabetic pregnancies in comparison with healthy controls in association with the local and peripheral immune response.