A Prospective Randomized Trial of Home Versus Hospital Care in Glucose Monitoring of Gestational Diabetes and Mild Gestational Hyperglycemia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Maternal mortality and morbidity rates
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Twin pregnancy diagnosed until the date of randomization or;
- •Fetal malformation diagnosed until the date of randomization.
结局指标
主要结局
Maternal mortality and morbidity rates
时间窗: participants will be followed regarding maternal and perinatal mortality and morbidity rates up to six weeks postnatal
Perinatal mortality and morbidity rates
时间窗: participants will be followed regarding maternal and perinatal mortality and morbidity rates up to six weeks postnatal
次要结局
- Maternal hospitalizations for any causes (home care) and prolonged hospitalization (hospital care)(participants will be followed for maternal hospitalizations for any causes and prolonged hospitalization up to six weeks postnatal)
- Length of stay for delivery(participants will be followed for length of stay for delivery, an expected average of 9 months)
- Postpartum repeated hospitalization(participants will be followed for Postpartum repeated hospitalization up to six weeks postnatal)
- Glucose control(participants will be followed for glucose control up to six weeks postnatal)
- Infants repeated hospitalizations(infants will be followed for repeated hospitalizations up to six weeks postnatal)
- Infants acute care visits(infants will be followed for acute care visits up to six weeks postnatal)
- Birth weight (classified as appropriate for gestational age = AIG, small for gestational age =SGA and large for gestational age = LGA)(birth weight will be assessed for an expected average of 9 months from the time of randomization)
- Maternal prenatal and postpartum acute care visits(participants will be followed for maternal prenatal and postpartum acute care visits up to six weeks postnatal)
- Biophysical profile tests(participants will be followed for biophysical profile tests up to six weeks postnatal)
- Incidence of premature infants(participants will be followed regarding incidence of premature infants up to six weeks postnatal)
- Costs(costs will be assessed for an expected average of 9 months from the time of randomization)
研究者
Silvana Andrea Molina Lima
PhD
UPECLIN HC FM Botucatu Unesp