Immunological changes in diabetic pregnancy.
Conditions
Interventions
None.
Sponsors
University Medical Centre Groningen
Eligibility
Inclusion criteria
Inclusion criteria: Group 1: Pregnant women with DM1 >18 en 18 en 18 en 18 and 18 and 18 en <40 yrs.
Exclusion criteria
Exclusion criteria: Group 1,2: 1. HbA1c >7,5% after 30 weeks of gestation; 2. Renal failure (serum creatinine >120 µmol/L); 3. Active treatment for auto-immune disease, except substitution therapy for primary hypothyroidism with TBII 2 times of miscarriage (defined as loss of pregnancy during the first 23 weeks of gestation); 4. All other maternal and foetal complications; 5. Known active disease. Group 4, 5: 1. HbA1c >7,5%; 2. Renal failure (serum creatinine >120 µmol/L); 3. Active treatment for auto-immune disease, except substitution therapy for primary hypothyroidism with TBII <1. Group 6: 1. Known active disease, except substitution therapy for primary hypothyroidism with TBII <1.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| To determine the maternal and foetal outcome of diabetic pregnancies in comparison with healthy controls in association with the local and peripheral immune response. | — |
Contacts
Public ContactB. Groen
Outcome results
None listed