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

NCT01441518 | Completed Phase 2

• 1 other identifier: upeclin/HC/FMB-Unesp-52
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Gestational Diabetes Mellitus; Pregestational Diabetes Mellitus; Mild Gestational Hyperglycemia

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (11)

• 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

Study Arms (2)

Home care

EXPERIMENTAL

Other: Home care

Hospital care

ACTIVE COMPARATOR

Other: Hospital care

Interventions

Home care OTHER

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 .

Home care

Hospital care OTHER

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.

Hospital care

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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;
• h ≥ 180; or
• h ≥ 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.

You may not qualify if:

• Twin pregnancy diagnosed until the date of randomization or;
• Fetal malformation diagnosed until the date of randomization.

Sponsors & Collaborators

• UPECLIN HC FM Botucatu Unesp: lead

Study Sites (1)

Faculdade de Medicina de Botucatu, Universidade Estadual Paulista

Botucatu, São Paulo, 18618-970, Brazil

Location

MeSH Terms

Conditions

Diabetes, Gestational

Interventions

Home Care Services

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Community Health Services; Health Services; Health Care Facilities Workforce and Services; Nursing Services

Study Officials

• Dr Regina El Dib, PhD

  UPECLIN HC FM Botucatu Unesp

  STUDY DIRECTOR

• Dr Marilza Rudge, PhD

  UPECLIN HC FM Botucatu Unesp

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: May 31, 2011
• First Posted: September 27, 2011
• Study Start: May 1, 2010
• Primary Completion: January 1, 2013
• Study Completion: November 1, 2013
• Last Updated: July 8, 2015

Record last verified: 2011-09

Locations

BR (1)