Gestational Diabetes and Health Outcomes in Mothers and Babies
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorMedical University of Graz
About this trial
Gestational diabetes mellitus (GDM) is a common pregnancy complication characterized by impaired glucose metabolism and increased insulin resistance. GDM is associated with adverse pregnancy outcomes and an increased long-term risk of metabolic and cardiovascular disease for both mother and offspring.
This prospective observational cohort study aims to establish a longitudinal pregnancy and birth cohort of women diagnosed with GDM. Pregnant women with a positive 75 g oral glucose tolerance test (OGTT) between gestational weeks 24 and 28 will be recruited after diagnosis and followed through late pregnancy, delivery, and early postpartum.
Participants will undergo two study visits during pregnancy, sample collection at delivery, and one postpartum visit 8-12 weeks after birth. Clinical data, physical measurements, questionnaire-based information, and biological samples will be collected from mothers and infants to enable comprehensive phenotyping of GDM pregnancies.
Data and biosamples from this cohort will be used for descriptive and hypothesis-driven analyses and may be compared with data from an existing longitudinal cohort of healthy pregnancies to support interpretation of GDM-related changes.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
ongoing pregnancy prior to the 32nd gestational week and a positive GDM screening
Disqualifiers
gestational age 32nd gestational week
fetal genetic anomalies /malformation
Trial population
The study population consists of pregnant women diagnosed with gestational diabetes mellitus (GDM) based on a positive 75 g oral glucose tolerance test performed as part of routine clinical care between gestational weeks 24 and 28. Participants are recruited after diagnosis at a tertiary care obstetric center and followed through late pregnancy, delivery, and early postpartum. Eligible participants are adults aged 18 years or older with an ongoing singleton pregnancy prior to gestational week 32. Women with major fetal anomalies are excluded. In addition, a non-pregnant reference cohort of healthy adult males and non-pregnant females may be recruited for selected analyses to provide pregnancy- and sex-independent reference data.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Maternal metabolic and cardiometabolic phenotype: Adiposity
Measured as fat mass and fat-free mass by air displacement plethysmography longitudinally after gestational diabetes diagnosis and during early postpartum follow-up.
Time frame
From study enrollment after GDM diagnosis (approximately gestational weeks 26-30) through 8-12 weeks postpartum.2
Maternal metabolic and cardiometabolic phenotype: fasting glucose
Fasting blood glucose as measured in mg/mL from NaF blood tubes longitudinally after gestational diabetes diagnosis and during early postpartum follow-up.
Time frame
From study enrollment after GDM diagnosis (approximately gestational weeks 26-30) through 8-12 weeks postpartum.3
Maternal metabolic and cardiometabolic phenotype: blood pressure
Resting systolic and diastolic blood pressure measured using standardized clinical procedures after gestational diabetes diagnosis and during early postpartum follow-up.
Time frame
From study enrollment after GDM diagnosis (approximately gestational weeks 26-30) through 8-12 weeks postpartum.4
Maternal metabolic and cardiometabolic phenotype: cytokine profile
Serum cytokine will be analysed by multiplexing after gestational diabetes diagnosis and during early postpartum follow-up.
Time frame
From study enrollment after GDM diagnosis (approximately gestational weeks 26-30) through 8-12 weeks postpartum.Sponsors and contacts
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Source ClinicalTrials.gov