Faculdade de Medicina de Botucatu, Universidade Estadual Paulista
Botucatu, São Paulo, 18618-970, Brazil
NCT Number: NCT01441518
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.
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Notify Me18 year–45 year
Female
Interventional
Phase 2
Botucatu, São Paulo, 18618-970, Brazil
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Home care, sometimes called "ambulatory care" or "outpatient", was defined as the blood-glucose self-monitored by the pregnant women at home. This project will provide glucometers to all those who are randomized to home care. The women will receive training for glucose control in pre-defined days, with the glucometer to obtain the mean glucose. According to blood-glucose levels in glycemic profile, insulin dose will be maintained or altered both in gestational diabetes as in mild gestational hyperglycemia .
Hospital care, sometimes called "acute care", was defined as control of maternal diabetes made at hospitals by admission to hospital. The blood-glucose and metabolic control are done in gestational diabetes and mild gestational hyperglycemia treated conventionally.
The hospitalized patients will have their glycemic control done in the hospital. . According to blood-glucose levels in glycemic profile , insulin dose will be maintained or altered both in gestational diabetes as in mild gestational hyperglycemia.
All the women of the study will be accompanied by a team of obstetricians specializing in high-risk pregnancies; residents; dietitians; nurses and neonatologists.
Time frame: participants will be followed regarding maternal and perinatal mortality and morbidity rates up to six weeks postnatal
Time frame: participants will be followed regarding maternal and perinatal mortality and morbidity rates up to six weeks postnatal
Time frame: birth weight will be assessed for an expected average of 9 months from the time of randomization
Time frame: participants will be followed for maternal hospitalizations for any causes and prolonged hospitalization up to six weeks postnatal
Time frame: infants will be followed for repeated hospitalizations up to six weeks postnatal
Time frame: infants will be followed for acute care visits up to six weeks postnatal
Time frame: participants will be followed for length of stay for delivery, an expected average of 9 months
Time frame: participants will be followed for maternal prenatal and postpartum acute care visits up to six weeks postnatal
Time frame: participants will be followed for biophysical profile tests up to six weeks postnatal
Time frame: participants will be followed regarding incidence of premature infants up to six weeks postnatal
Time frame: participants will be followed for Postpartum repeated hospitalization up to six weeks postnatal
Time frame: participants will be followed for glucose control up to six weeks postnatal
Time frame: costs will be assessed for an expected average of 9 months from the time of randomization
UPECLIN HC FM Botucatu Unesp
Other
A Prospective Randomized Trial of Home Versus Hospital Care in Glucose Monitoring of Gestational Diabetes and Mild Gestational Hyperglycemia
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