Home Versus Hospital Care in Glucose Monitoring of Gestational Diabetes and Mild Gestational Hyperglycemia

UPECLIN HC FM Botucatu Unesp

Status and phase: Completed; Phase 2

Conditions: Mild Gestational Hyperglycemia; Gestational Diabetes Mellitus; Pregestational Diabetes Mellitus

Treatments: Other: Home care; Other: Hospital care

Study type: Interventional

Funder types: Other

Identifiers

NCT01441518

upeclin/HC/FMB-Unesp-52

Details and patient eligibility

About

Pregnancies complicated by diabetes and mild gestational hyperglycemia are associated with increased perinatal and maternal complications. The most serious maternal complication is the risk of developing type 2 diabetes after 10-12 years of the delivery. Perinatal complications include fetal macrosomia with consequent increased risk of obstetrical trauma and hypoxia/asphyxia, high rates of cesarean section, respiratory distress syndrome, and metabolic disorders at birth. Regardless of the diagnosis of diabetes and mild gestational hyperglycemia, the perinatal outcome is directly related to maternal metabolic control. For the tight control of blood glucose, pregnant women are treated as home care (outpatient) or hospital care. Objective: To evaluate the cost-effectiveness and safety of home versus hospital care of gestational diabetes and mild gestational hyperglycemia.

Enrollment: 80 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients who were diagnosed with gestational, pre gestational diabetes mellitus or mild gestational hyperglycemia. Patients should have one of the four criteria as following:

• Patients with positive screening for GDM presenting a TTG of 75 g and one of the values below:

  • fasting glucose ≥ 92;
  • 1h ≥ 180; or
  • 2h ≥ 153 will be considered gestational diabetes mellitus (GDM) and these patients will be enrolled to a run-in phase consisting of diet and exercise during 15 days. If the patients still present an abnormal glycemic profile instead of the previous treatment with diet and exercise they will be enrolled in the study and randomized to either home or hospital care; or

• Patients with pre gestational diabetes mellitus type 1 or 2; or

• Patients with positive screening for GDM and presenting normal TTG of 75 g and abnormal glycemic profile, fasting ≥ 85 mg k/l 10 h to 18h post prandial ≥ 130 mg k/ ( Rudge et al,1990).

• Normal TTG and an abnormal glycemic profile will be considered as mild gestational hyperglycemia

• Patient provided written informed consent.

Exclusion criteria

• Twin pregnancy diagnosed until the date of randomization or;
• Fetal malformation diagnosed until the date of randomization.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Home care

Experimental group

Treatment:

Other: Home care

Hospital care

Active Comparator group

Treatment:

Other: Hospital care