Back to resultsHome Versus Hospital Care in Glucose Monitoring of Gestational Diabetes and Mild Gestational Hyperglycemia
Primary Purpose
Gestational Diabetes Mellitus, Pregestational Diabetes Mellitus, Mild Gestational Hyperglycemia
Status
Completed
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
Home care
Hospital care
Sponsored by
About this trial
This is an interventional treatment trial for Gestational Diabetes Mellitus
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.
Sites / Locations
- Faculdade de Medicina de Botucatu, Universidade Estadual Paulista
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Home care
Hospital care
Arm Description
Outcomes
Primary Outcome Measures
Maternal mortality and morbidity rates
Perinatal mortality and morbidity rates
Secondary Outcome Measures
Birth weight (classified as appropriate for gestational age = AIG, small for gestational age =SGA and large for gestational age = LGA)
Maternal hospitalizations for any causes (home care) and prolonged hospitalization (hospital care)
Infants repeated hospitalizations
Infants acute care visits
Length of stay for delivery
Maternal prenatal and postpartum acute care visits
Biophysical profile tests
Incidence of premature infants
Postpartum repeated hospitalization
Glucose control
Costs
Full Information
NCT ID
NCT01441518
First Posted
May 31, 2011
Last Updated
July 7, 2015
Sponsor
UPECLIN HC FM Botucatu Unesp
1. Study Identification
Unique Protocol Identification Number
NCT01441518
Brief Title
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
2. Study Status
Record Verification Date
September 2011
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
November 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
UPECLIN HC FM Botucatu Unesp
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gestational Diabetes Mellitus, Pregestational Diabetes Mellitus, Mild Gestational Hyperglycemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Home care
Arm Type
Experimental
Arm Title
Hospital care
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Home care
Intervention Description
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 .
Intervention Type
Other
Intervention Name(s)
Hospital care
Intervention Description
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.
Primary Outcome Measure Information:
Title
Maternal mortality and morbidity rates
Time Frame
participants will be followed regarding maternal and perinatal mortality and morbidity rates up to six weeks postnatal
Title
Perinatal mortality and morbidity rates
Time Frame
participants will be followed regarding maternal and perinatal mortality and morbidity rates up to six weeks postnatal
Secondary Outcome Measure Information:
Title
Birth weight (classified as appropriate for gestational age = AIG, small for gestational age =SGA and large for gestational age = LGA)
Time Frame
birth weight will be assessed for an expected average of 9 months from the time of randomization
Title
Maternal hospitalizations for any causes (home care) and prolonged hospitalization (hospital care)
Time Frame
participants will be followed for maternal hospitalizations for any causes and prolonged hospitalization up to six weeks postnatal
Title
Infants repeated hospitalizations
Time Frame
infants will be followed for repeated hospitalizations up to six weeks postnatal
Title
Infants acute care visits
Time Frame
infants will be followed for acute care visits up to six weeks postnatal
Title
Length of stay for delivery
Time Frame
participants will be followed for length of stay for delivery, an expected average of 9 months
Title
Maternal prenatal and postpartum acute care visits
Time Frame
participants will be followed for maternal prenatal and postpartum acute care visits up to six weeks postnatal
Title
Biophysical profile tests
Time Frame
participants will be followed for biophysical profile tests up to six weeks postnatal
Title
Incidence of premature infants
Time Frame
participants will be followed regarding incidence of premature infants up to six weeks postnatal
Title
Postpartum repeated hospitalization
Time Frame
participants will be followed for Postpartum repeated hospitalization up to six weeks postnatal
Title
Glucose control
Time Frame
participants will be followed for glucose control up to six weeks postnatal
Title
Costs
Time Frame
costs will be assessed for an expected average of 9 months from the time of randomization
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr Regina El Dib, PhD
Organizational Affiliation
UPECLIN HC FM Botucatu Unesp
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Dr Marilza Rudge, PhD
Organizational Affiliation
UPECLIN HC FM Botucatu Unesp
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculdade de Medicina de Botucatu, Universidade Estadual Paulista
City
Botucatu
State/Province
Sao Paulo
ZIP/Postal Code
18618-970
Country
Brazil
12. IPD Sharing Statement
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Home Versus Hospital Care in Glucose Monitoring of Gestational Diabetes and Mild Gestational Hyperglycemia
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