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

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

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.

Study Overview

• Status: Completed
• Conditions: Gestational Diabetes Mellitus; Pregestational Diabetes Mellitus; Mild Gestational Hyperglycemia
• Intervention / Treatment: Other: Home care; Other: Hospital care

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 2

Contacts and Locations

Study Locations

• Brazil
  • Sao Paulo
    • Botucatu, Sao Paulo, Brazil, 18618-970
      • Faculdade de Medicina de Botucatu, Universidade Estadual Paulista

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Home care	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 .
Active Comparator: Hospital care	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Maternal mortality and morbidity rates	participants will be followed regarding maternal and perinatal mortality and morbidity rates up to six weeks postnatal
Perinatal mortality and morbidity rates	participants will be followed regarding maternal and perinatal mortality and morbidity rates up to six weeks postnatal

Secondary Outcome Measures

Outcome Measure	Time Frame
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 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
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
Length of stay for delivery	participants will be followed for length of stay for delivery, an expected average of 9 months
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
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
Costs	costs will be assessed for an expected average of 9 months from the time of randomization

Collaborators and Investigators

• Sponsor: UPECLIN HC FM Botucatu Unesp
• Investigators: Study Director: Dr Regina El Dib, PhD, UPECLIN HC FM Botucatu Unesp; Principal Investigator: Dr Marilza Rudge, PhD, UPECLIN HC FM Botucatu Unesp

Study record dates

Study Major Dates

• Study Start: May 1, 2010
• Primary Completion (Actual): January 1, 2013
• Study Completion (Actual): November 1, 2013

Study Registration Dates

• First Submitted: May 31, 2011
• First Submitted That Met QC Criteria: September 26, 2011
• First Posted (Estimate): September 27, 2011

Study Record Updates

• Last Update Posted (Estimate): July 8, 2015
• Last Update Submitted That Met QC Criteria: July 7, 2015
• Last Verified: September 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Pregnancy Complications; Hyperglycemia; Diabetes Mellitus; Diabetes, Gestational
• Other Study ID Numbers: upeclin/HC/FMB-Unesp-52