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First Trimester Prediction of Gestational Diabetes Mellitus by Continuous Glucose Monitoring.

Recruitingn/aAges 18 Years - anyFemaleFundacion para la Formacion e Investigacion Sanit…
NCT06874907 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Gestational diabetes mellitus (GDM) is the most common complication of pregnancy, with an incidence rate of 10-15% \[1\]. Common risk factors for GDM are increased maternal age and weight and as a consequence of women delaying childbirth and increasing incidence of obesity, there is a corresponding increase in the rate of GDM. GDM is associated with an increased risk of maternal and perinatal short and long-term complications . These include macrosomia, shoulder dystocia, neonatal hypoglycaemia, neonatal hyperbilirubinemia, and perinatal mortality. Maternal complications include higher risks of hypertensive disorders, perineal trauma, and caesarean section. Additionally, both the mothers with GDM and their infants have an increased risk of developing type 2 diabetes mellitus and cardiovascular disease later in life . Screening and diagnosis of GDM is currently based on an oral glucose t

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📋 Eligibility rules (as published)
Inclusion Criteria: * Maternal age ≥ 18 years * Planned antenatal care at the same centre (i.e. not planning to move before delivery). * Singleton pregnancy. * Informed and written consent. Exclusion Criteria: * Age \<18 years; * Multiple pregnancy in current pregnancy; * Unconscious or very ill; · Serious mental illness; * Learning difficulties; * Not fluent in local language and absence of interpreter; * Severe congenital anomaly on ultrasound; * Pre-existing diabetes mellitus type 1 or 2; * Patients undergoing metformin therapy for infertility. * Significant pre-pregnancy comorbidities that increase risk in pregnancy, for example renal failure, severe liver disease, transplantation, cardiac failure, psychiatric conditions requiring in-patient admission (\<1 year); * Significant co-morbidity in the current pregnancy, nephropathy (estimated GFR \<60ml/min), other physical or psychological conditions likely to interfere with the conduct of the study and/or interpretation of the trial results; * Participating in another intervention study that influences outcomes of this study; * Allergy to adhesive materials; * Allergy to any of the components of the glucose test:
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What it tests

  • Glucose monitoring
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Where

1 site
HCUVA
El Palmar, Spain
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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