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. Because microalbuminuria in pregnant pregestational diabetes patients predicts the development of preeclampsia, we believe that it is caused by plasmin(plasminogen) lose from plasma to the urine. The investigators want to test the correlation between measurable plasmin/plasminogen in the urine early in pregnancy and the development of preeclampsia in 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.
Show Detailed Description
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|