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Introduction Despite technological developments and intensified care, pregnancies in women with pre-existing diabetes are still considered high-risk pregnancies. The rate of adverse outcomes in pregnancies affected by diabetes in Denmark is currently unknown, and there is a limited understanding of mechanisms contributing to this elevated risk. To address these gaps, the Danish Diabetes Birth Registry 2 (DDBR2) was established. The aims of this registry are to evaluate maternal and fetal-neonatal outcomes based on 5 years cohort data, and to identify pathophysiology and risk factors associated with short-term and long-term outcomes of pregnancies in women with pre-existing diabetes.Methods and analysis The DDBR2 registry is a nationwide 5-year prospective cohort with an inclusion period from February 2023 to February 2028 of pregnancies in women with all types of pre-existing diabetes and includes registry, clinical and questionnaire data and biological samples of mother–partner–child trios. Eligible families (parents age ≥18 years and sufficient proficiency in Danish or English) can participate by either (1) basic level data obtained from medical records (mother and child) and questionnaires (partner) or (2) basic level data and additional data which includes questionnaires (mother and partner) and blood samples (all). The primary maternal outcome is Hemoglobin A1c (HbA1c) levels at the end of pregnancy and the primary offspring endpoint is the birth weight SD score. The DDBR2 registry will be complemented by genetic, epigenetic and metabolomic data as well as a biobank for future research, and the cohort will be followed through data from national databases to illuminate possible mechanisms that link maternal diabetes and other parental factors to a possible increased risk of adverse long-term child outcomes.Ethics and dissemination Approval from the Ethical Committee is obtained (S-20220039). Findings will be sought published in international scientific journals and shared among the participating hospitals and policymakers.Trial registration number NCT05678543. more...

ObjectivesPre-eclampsia (PE) is characterised by renal glomerular endotheliosis and injury to the glomerular filtration barrier with proteinuria. Patients with PE display aberrant filtration of the plasma proenzyme plasminogen which is activated, in the tubular fluid, to plasmin. Plasmin may activate the epithelial sodium channel and cause impaired sodium excretion and contribute to hypertension. An explorative study was conducted to test the association between urinary total plasminogen/plasmin and the development of PE. A positive association was hypothesised.DesignAn observational, explorative, nested case–control study of healthy pregnant women.SettingsA Danish County hospital. Samples were collected between 2001 and 2004.Participants1631 healthy pregnant women participated. Urine samples were collected longitudinally six times during pregnancy. 30 developed PE (cases) and were compared with 146 randomly selected healthy pregnant women (controls).Primary outcomeThe association between total plasminogen/plasmin excreted in the urine and PE development is expressed by ORs. Total urinary excretion of plasminogen/plasmin was defined by the urine plasminogen-plasmin/creatinine ratio.Secondary outcomeThe association between urine (u)-albumin/creatinine ratio, u-aldosterone/creatinine ratio and PE development is expressed by ORs. The correlation between urinary (u-) plasmin and u-aldosterone concentration is expressed as a correlation coefficient.ResultsThe development of PE in late pregnancy was associated with increased levels of the urine plasminogen-plasmin/creatinine ratio (OR=2.35; 95% CI: 1.12 to 4.93; p more...

ObjectiveIn obese women, 1) to assess whether lower gestational weight gain (GWG) during pregnancy in the lifestyle intervention group of a randomized controlled trial (RCT) resulted in differences in offspring anthropometrics and body composition, and 2) to compare offspring outcomes to a reference group of children born to women with a normal Body Mass Index (BMI).Research design and methodsThe LiPO (Lifestyle in Pregnancy and Offspring) study was an offspring follow-up of a RCT with 360 obese pregnant women with a lifestyle intervention during pregnancy including dietary advice, coaching and exercise. The trial was completed by 301 women who were eligible for follow-up. In addition, to the children from the RCT, a group of children born to women with a normal BMI were included as a reference group. At 2.8 (range 2.5-3.2) years, anthropometrics were measured in 157 children of the RCT mothers and in 97 reference group children with Body Mass Index (BMI) Z-score as a primary outcome. Body composition was estimated by Dual Energy X-ray (DEXA) in 123 successful scans out of 147 (84%).ResultsNo differences between randomized groups were seen in mean (95% C.I.) BMI Z-score (intervention group 0.06 [-0.17; 0.29] vs. controls -0.18 [-0.43; 0.05]), in the percentage of overweight or obese children (10.9% vs. 6.7%), in other anthropometrics, or in body composition values by DEXA. Outcomes between children from the RCT and the reference group children were not significantly different.ConclusionsThe RCT with lifestyle intervention in obese pregnant women did not result in any detectable effect on offspring anthropometrics or body composition by DEXA at 2.8 years of age. This may reflect the limited difference in GWG between intervention and control groups. Offspring of obese mothers from the RCT were comparable to offspring of mothers with a normal BMI. more...

Gestational diabetes mellitus (GDM) is associated with adverse pregnancy outcomes including large for gestational age infants. Individualizing the management of women with GDM based on the likelihood of needing insulin may improve pregnancy outcomes. The aim of this study is to identify characteristics associated with a need for insulin in women with GDM, and to develop a predictive model for insulin requirement. A historical cohort study was conducted among all women with GDM in a singleton pregnancy at Aarhus University Hospital from 2012 to 2017. Variables associated with insulin treatment were identified through multivariable logistic regression. The variables were dichotomized and included in a point scoring system aiming to predict the likelihood of needing insulin. Seven variables were associated with needing insulin: family history of diabetes, current smoker, multiparity, prepregnancy body mass index, gestational age at the oral glucose tolerance test (OGTT), 2-h glucose value at the OGTT and hemoglobin A1c at diagnosis. A risk score was calculated assigning one point to each variable. On ROC analysis, a cut-off value of ≥3 points optimally predicted a requirement for insulin. This prediction model may be clinically useful to predict requirement for insulin treatment after further validation. more...