Urine-plasminogen as a Predictor for Development Of Preeclampsia in Pregnant Women With Type 1 Diabetes Mellitus
A tonic active epithelial Na+ channel (ENaC) in pre-eclampsia (PE) escaped normal hormonal control may offer an attractive explanatory model for the pathophysiology of established PE. The channel is activated by plasmin. Microalbuminuria predicts the development of pre-eclampsia in pregnant patients with pregestational diabetes type 1. The investigators hypothesize that urine-plasmin excreted in the kidneys, when proteinuria occurs, could be the cause. The investigators want to test the correlation between measurable plasmin/plasminogen in the urine early in pregnancy and the development of preeclampsia in pregnant patients with type 1 diabetes.
Type 1 Diabetes
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Urine-plasminogen as a Predictor for Development Of Preeclampsia in Pregnant Women With Type 1 Diabetes Mellitus|
- preeclampsia [ Time Frame: 3 years ] [ Designated as safety issue: No ]The development of preeclampsia, defined by hypertension ( > 140/90 mmHg) and proteinuria ( >0,3 g/24 hour).
- preterm delivery [ Time Frame: 3 years ] [ Designated as safety issue: No ]post-partum registration of preterm delivery
- light for gestational age [ Time Frame: 3 years ] [ Designated as safety issue: No ]post-partum registration of "light for gestational age"
Biospecimen Retention: Samples With DNA
whole blood serum plasma urine
|Study Start Date:||June 2013|
|Estimated Study Completion Date:||February 2016|
|Estimated Primary Completion Date:||April 2015 (Final data collection date for primary outcome measure)|
pregestational type 1 diabetes
It is an observational study. No intervention is made.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01821053
|Gynelogical Obstetrical Department||Recruiting|
|Skejby, Aarhus N, Denmark, 8200|
|Contact: Lise H. Nielsen, doctor +4553347735 firstname.lastname@example.org|
|Contact: Per Ovesen, doctor +4561669728 Per.Ovesen@dadlnet.dk|
|Principal Investigator: Lise H. Nielsen, Doctor|
|Study Director:||Boye L. Jensen, Professor||cardiovascular and renal research department, Odense University Hospital|