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

Gestational Diabetes Mellitus Clinical Trial

Official title:

A Prospective Randomized Trial of Home Versus Hospital Care in Glucose Monitoring of Gestational Diabetes and Mild Gestational Hyperglycemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01441518
• Other study ID #: upeclin/HC/FMB-Unesp-52
• Status: Completed
• Phase: Phase 2
• First received: May 31, 2011
• Last updated: July 7, 2015
• Start date: May 2010
• Est. completion date: November 2013

Study information

• Verified date: September 2011
• Source: UPECLIN HC FM Botucatu Unesp
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: November 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• Gestational Diabetes Mellitus
• Hyperglycemia
• Mild Gestational Hyperglycemia
• Pregestational Diabetes Mellitus

Intervention

Other:
• Home care
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
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.

Locations

Country	Name	City	State
Brazil	Faculdade de Medicina de Botucatu, Universidade Estadual Paulista	Botucatu	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
UPECLIN HC FM Botucatu Unesp

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maternal mortality and morbidity rates		participants will be followed regarding maternal and perinatal mortality and morbidity rates up to six weeks postnatal	Yes
Primary	Perinatal mortality and morbidity rates		participants will be followed regarding maternal and perinatal mortality and morbidity rates up to six weeks postnatal	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	Infants repeated hospitalizations		infants will be followed for repeated hospitalizations up to six weeks postnatal	Yes
Secondary	Infants acute care visits		infants will be followed for acute care visits up to six weeks postnatal	Yes
Secondary	Length of stay for delivery		participants will be followed for length of stay for delivery, an expected average of 9 months	No
Secondary	Maternal prenatal and postpartum acute care visits		participants will be followed for maternal prenatal and postpartum acute care visits up to six weeks postnatal	Yes
Secondary	Biophysical profile tests		participants will be followed for biophysical profile tests up to six weeks postnatal	No
Secondary	Incidence of premature infants		participants will be followed regarding incidence of premature infants up to six weeks postnatal	Yes
Secondary	Postpartum repeated hospitalization		participants will be followed for Postpartum repeated hospitalization up to six weeks postnatal	Yes
Secondary	Glucose control		participants will be followed for glucose control up to six weeks postnatal	Yes
Secondary	Costs		costs will be assessed for an expected average of 9 months from the time of randomization	No