About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Age <18 years;
Multiple pregnancy in current pregnancy;
Unconscious or very ill; · Serious mental illness;
Learning difficulties;
Trial population
Pregnant patients over 18 years of age
Trial design
Cohort
Prospective
Treatments tested in this trial
Glucose monitoring
Procedure/SurgeryGlucose monitoring
Treatment groups
Trial outcomes
Primary outcomes
Value of CGM (Continuous glucose monitoring) at 12 and 28 weeks of gestation in the prediction of GDM (Gestational diabetes mellitus )
GDM is defined by abnormal results of 75mg OGTT(Oral Glucose Tolerance Test) at 28 weeks' gestation
Secondary outcomes
Number of patients with Gestational hypertension
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)
Glycaemic profile according to CGM (Continuous glucose monitoring)at 12 and 28 weeks and OGTT(Gestational diabetes mellitus ) results at 28 weeks
Number of patients with Delivery by caesarean section
Glycaemic profile according to CGM (Continuous glucose monitoring)at 12 and 28 weeks and OGTT(Gestational diabetes mellitus ) results at 28 weeks
Number of patients with Stillbirth, neonatal death, perinatal death
Glycaemic profile according to CGM (Continuous glucose monitoring)at 12 and 28 weeks and OGTT(Gestational diabetes mellitus ) results at 28 weeks
Number of patients with Large for gestational age neonate (\>90th and 95th percentile for gestation)
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
Lead sponsor
King's College Hospital NHS Trust
Collaborator