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| Name | Class |
|---|---|
| King's College Hospital NHS Trust | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Continuous glucose monitoring | First trimester prediction of gestational diabetes mellitus by continuous glucose monitoring |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glucose monitoring | Procedure | Glucose monitoring |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Up to 28 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Up to 28 weeks |
| Glycaemic profile according to CGM (Continuous glucose monitoring)at 12 and 28 weeks and OGTT(Gestational diabetes mellitus ) results at 28 weeks |
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Inclusion Criteria:
Exclusion Criteria:
Age <18 years;
Multiple pregnancy in current pregnancy;
Pregnancy women
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Pregnant patients over 18 years of age
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Catalina de Paco Matallana, MD | Contact | 968369500 | katy.depaco@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Catalina de Paco Matallana, MD | HCUVA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HCUVA | Recruiting | El Palmar | Murcia | 30120 | Spain |
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Number of patients with Delivery by caesarean section |
| Up to 28 weeks |
| 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 | Up to 28 weeks |
| 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) | Up to 28 weeks |
| 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 Neonatal hyperglycaemia | Up to 28 weeks |
| 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 Neonatal hyperbilirubinemia | Up to 28 weeks |
| 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 Neonatal unit (NNU) admission for ≥48 hours | Up to 28 weeks |
| Glycaemic profile according to CGM (Continuous glucose monitoring)at 12 and 28 weeks and OGTT(Gestational diabetes mellitus ) results at 28 weeks | Number of days (Length of stay) in the Neonatal Intensive Unit. | Up to 28 weeks |