Clinical trial NCT01441518: Home Versus Hospital Care in Glucose Monitoring of Gestational Diabetes and Mild Gestational Hyperglycemia
Official title: A Prospective Randomized Trial of Home Versus Hospital Care in Glucose Monitoring of Gestational Diabetes and Mild Gestational Hyperglycemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Gestational Diabetes Mellitus
Pregestational Diabetes Mellitus
Mild Gestational Hyperglycemia
Lead sponsor: UPECLIN HC FM Botucatu Unesp
Sponsor class: OTHER
First posted: 2011-09-27
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Maternal mortality and morbidity rates
timeFrame: participants will be followed regarding maternal and perinatal mortality and morbidity rates up to six weeks postnatal
measure: Perinatal mortality and morbidity rates
timeFrame: participants will be followed regarding maternal and perinatal mortality and morbidity rates up to six weeks postnatal
Secondary outcomes:
measure: Birth weight (classified as appropriate for gestational age = AIG, small for gestational age =SGA and large for gestational age = LGA)
timeFrame: birth weight will be assessed for an expected average of 9 months from the time of randomization
measure: Maternal hospitalizations for any causes (home care) and prolonged hospitalization (hospital care)
timeFrame: participants will be followed for maternal hospitalizations for any causes and prolonged hospitalization up to six weeks postnatal
measure: Infants repeated hospitalizations
timeFrame: infants will be followed for repeated hospitalizations up to six weeks postnatal
measure: Infants acute care visits
timeFrame: infants will be followed for acute care visits up to six weeks postnatal
measure: Length of stay for delivery
timeFrame: participants will be followed for length of stay for delivery, an expected average of 9 months
measure: Maternal prenatal and postpartum acute care visits
timeFrame: participants will be followed for maternal prenatal and postpartum acute care visits up to six weeks postnatal
measure: Biophysical profile tests
timeFrame: participants will be followed for biophysical profile tests up to six weeks postnatal
measure: Incidence of premature infants
timeFrame: participants will be followed regarding incidence of premature infants up to six weeks postnatal
measure: Postpartum repeated hospitalization
timeFrame: participants will be followed for Postpartum repeated hospitalization up to six weeks postnatal
measure: Glucose control
timeFrame: participants will be followed for glucose control up to six weeks postnatal
measure: Costs
timeFrame: costs will be assessed for an expected average of 9 months from the time of randomization
Other outcomes:
Locations:
city: Botucatu
country: Brazil
facility: Faculdade de Medicina de Botucatu, Universidade Estadual Paulista
state: Sao Paulo
Study officials:
affiliation: UPECLIN HC FM Botucatu Unesp
name: Dr Regina El Dib, PhD
role: STUDY_DIRECTOR
affiliation: UPECLIN HC FM Botucatu Unesp
name: Dr Marilza Rudge, PhD
role: PRINCIPAL_INVESTIGATOR
References: