I42.9
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Pregnancy with insulin dependent Diabetes mellitus in the with follow up at the obstetric department of the general hospital in Ålesund / Norway, first appointment with manifested insulindependent D. mellitus latest at 30+6 wks of gestation 2. full term birth after 37+0 - 42+0 gestational age. 3. documented consent of the parents. 4. A control group will be recruted by including the nextborn fullterm infant of a non diabetic mother after birth of an infant from the target group. Documented consent also in this group. patient group
Exclusion criteria
Exclusion criteria: 1. congenital major malformations or diseases in the newborn requiring immediate transfer to another hospital, except from cardiac malformations. 2. No fetal echocardiography from the period 28+0 - 30+6 weeks of gestation. This criterion is not valid for the control group 3. Down-syndrome in the newborn 4. small for gestational age 5. Prematurity or postmaturity - it means: A Patient that has been included in the fetal period has to be exluded if pre- or postmatur at birth
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| frequency of septum hypertrophy, cardiomyopathy and ventricle dysfunction by echocardiography inside 48 hours after birth | — |
Secondary
| Measure | Time frame |
|---|---|
| Correlation between septumhypertrophy, cardiomyopathy and ventricle dysfunction and clinical symptoms || Correlation between septumhypertrophy, cardiomyopathy, ventricle dysfunction and HbA1c+C-peptide (from the pregnant) C-peptide+insulin (from cord blood) and hypoglycemia of the newborn by gathering of the results from routine blood samples under observation in the NICU || Incident of congenital heart malformation || outcome of septumhypertrophy/ventricle dysfunction/cardiomyopathy by follow up echocardiography at 4 weeks and 3 months | — |
Countries
Norway
Contacts
Helse Sunnmøre Sykehus i Aalesund 6026 Ålesund;Helse Sunnmøre sykehus i Aalesund 6020 Aalesund