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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01441518
First Posted: September 27, 2011
Last Update Posted: July 8, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Silvana Andrea Molina Lima, UPECLIN HC FM Botucatu Unesp
  Purpose
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.

Condition Intervention Phase
Gestational Diabetes Mellitus Pregestational Diabetes Mellitus Mild Gestational Hyperglycemia Other: Home care Other: Hospital care Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Randomized Trial of Home Versus Hospital Care in Glucose Monitoring of Gestational Diabetes and Mild Gestational Hyperglycemia

Resource links provided by NLM:


Further study details as provided by Silvana Andrea Molina Lima, UPECLIN HC FM Botucatu Unesp:

Primary Outcome Measures:
  • Maternal mortality and morbidity rates [ Time Frame: participants will be followed regarding maternal and perinatal mortality and morbidity rates up to six weeks postnatal ]
  • 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 Measures:
  • 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 ]
  • 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 ]
  • Infants repeated hospitalizations [ Time Frame: infants will be followed for repeated hospitalizations up to six weeks postnatal ]
  • Infants acute care visits [ Time Frame: infants will be followed for acute care visits up to six weeks postnatal ]
  • Length of stay for delivery [ Time Frame: participants will be followed for length of stay for delivery, an expected average of 9 months ]
  • 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 ]
  • Biophysical profile tests [ Time Frame: participants will be followed for biophysical profile tests up to six weeks postnatal ]
  • Incidence of premature infants [ Time Frame: participants will be followed regarding incidence of premature infants up to six weeks postnatal ]
  • Postpartum repeated hospitalization [ Time Frame: participants will be followed for Postpartum repeated hospitalization up to six weeks postnatal ]
  • Glucose control [ Time Frame: participants will be followed for glucose control up to six weeks postnatal ]
  • Costs [ Time Frame: costs will be assessed for an expected average of 9 months from the time of randomization ]

Enrollment: 80
Study Start Date: May 2010
Study Completion Date: November 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01441518


Locations
Brazil
Faculdade de Medicina de Botucatu, Universidade Estadual Paulista
Botucatu, Sao Paulo, Brazil, 18618-970
Sponsors and Collaborators
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
  More Information

Responsible Party: Silvana Andrea Molina Lima, PhD, UPECLIN HC FM Botucatu Unesp
ClinicalTrials.gov Identifier: NCT01441518     History of Changes
Other Study ID Numbers: upeclin/HC/FMB-Unesp-52
First Submitted: May 31, 2011
First Posted: September 27, 2011
Last Update Posted: July 8, 2015
Last Verified: September 2011

Additional relevant MeSH terms:
Diabetes Mellitus
Hyperglycemia
Diabetes, Gestational
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pregnancy Complications