HCUVA
El Palmar, Murcia, 30120, Spain
Location status: Recruiting
NCT Number: NCT06874907
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 tolerance (OGTT), which is carried out at 26-28 weeks' gestation. In addition, an OGTT is carried out at 11-13 weeks in women considered to be at increased risk of GDM based on their demographic characteristics and medical history. Screening and diagnosis of GDM is traditionally delayed until the late second or early third trimester of pregnancy with the rationale that the diabetogenic effects of pregnancy increase with gestation and therefore delayed testing would maximize the detection rate.
Interested in participating?
Request Info18 year and older
Female
Observational
El Palmar, Murcia, 30120, Spain
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Glucose monitoring
Time frame: Up to 28 weeks
GDM is defined by abnormal results of 75mg OGTT(Oral Glucose Tolerance Test) at 28 weeks' gestation
Time frame: Up to 28 weeks
blood pressure readings are higher than 140/90 mm Hg in a woman who had normal blood pressure prior to 20 weeks and has no proteinuria (excess protein in the urine)
Time frame: Up to 28 weeks
Number of patients with Delivery by caesarean section
Time frame: Up to 28 weeks
Number of patients with Stillbirth, neonatal death, perinatal death
Time frame: Up to 28 weeks
Number of patients with Large for gestational age neonate (>90th and 95th percentile for gestation)
Time frame: Up to 28 weeks
Number of patients with Neonatal hyperglycaemia
Time frame: Up to 28 weeks
Number of patients with Neonatal hyperbilirubinemia
Time frame: Up to 28 weeks
Number of patients with Neonatal unit (NNU) admission for ≥48 hours
Time frame: Up to 28 weeks
Number of days (Length of stay) in the Neonatal Intensive Unit.
Contact information is provided by the study sponsor or research team.
Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
Other
Acronym: GLUCO-GCM
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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