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Glucose metabolism and systolic ventricular function in newborns of diabetic mothers

Glucose metabolism and systolic ventricular function in newborns of diabetic mothers

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00000202
Enrollment
84
Registered
2009-10-23
Start date
2011-01-14
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

I42.9

Interventions

Group 1: The patient group: fetus of pregnant women with insulindependent diabetes mellitus who get included consecutively in prepartal special consultation hour at gestational age 28+0 - 30+6 weeks i

Sponsors

Helse Sunnmøre HF Sykehus i Aalesund
Lead Sponsor

Eligibility

Sex/Gender
All

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

MeasureTime frame
frequency of septum hypertrophy, cardiomyopathy and ventricle dysfunction by echocardiography inside 48 hours after birth

Secondary

MeasureTime 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

Public ContactKristoffer;Lutz Brodwall;Nietsch

Helse Sunnmøre Sykehus i Aalesund 6026 Ålesund;Helse Sunnmøre sykehus i Aalesund 6020 Aalesund

kristoffer.brodwall@helse-sunnmore.no;lutz.nietsch@helse-sunnmore.no0047 70105000;0047-70105000

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026