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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2011 by UPECLIN HC FM Botucatu Unesp.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Marilza Vieira Cunha Rudge, UPECLIN HC FM Botucatu Unesp
ClinicalTrials.gov Identifier:
NCT01441518
First received: May 31, 2011
Last updated: September 26, 2011
Last verified: September 2011
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 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 ] [ Designated as safety issue: Yes ]
  • Perinatal mortality and morbidity rates [ Time Frame: participants will be followed regarding maternal and perinatal mortality and morbidity rates up to six weeks postnatal ] [ Designated as safety issue: Yes ]

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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Infants repeated hospitalizations [ Time Frame: infants will be followed for repeated hospitalizations up to six weeks postnatal ] [ Designated as safety issue: Yes ]
  • Infants acute care visits [ Time Frame: infants will be followed for acute care visits up to six weeks postnatal ] [ Designated as safety issue: Yes ]
  • Length of stay for delivery [ Time Frame: participants will be followed for length of stay for delivery, an expected average of 9 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Biophysical profile tests [ Time Frame: participants will be followed for biophysical profile tests up to six weeks postnatal ] [ Designated as safety issue: No ]
  • Incidence of premature infants [ Time Frame: participants will be followed regarding incidence of premature infants up to six weeks postnatal ] [ Designated as safety issue: Yes ]
  • Postpartum repeated hospitalization [ Time Frame: participants will be followed for Postpartum repeated hospitalization up to six weeks postnatal ] [ Designated as safety issue: Yes ]
  • Glucose control [ Time Frame: participants will be followed for glucose control up to six weeks postnatal ] [ Designated as safety issue: Yes ]
  • Costs [ Time Frame: costs will be assessed for an expected average of 9 months from the time of randomization ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: May 2010
Estimated Study Completion Date: January 2013
Estimated 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

Ages Eligible for Study:   18 Years to 45 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01441518

Contacts
Contact: Dr Marilza Rudge, PhD +55 14 3811 6227 marilzarudge@ig.com.br
Contact: Dr Silvana M Lima, PhD +55 14 3811 6070 smolina@fmb.unesp.br

Locations
Brazil
Faculdade de Medicina de Botucatu, Universidade Estadual Paulista Recruiting
Botucatu, Sao Paulo, Brazil, 18618-970
Contact: Dr Silvana M Lima, PhD    +5514 3811 6070    smolina@fmb.unesp.br   
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

No publications provided

Responsible Party: Marilza Vieira Cunha Rudge, PhD, UPECLIN HC FM Botucatu Unesp
ClinicalTrials.gov Identifier: NCT01441518     History of Changes
Other Study ID Numbers: upeclin/HC/FMB-Unesp-52
Study First Received: May 31, 2011
Last Updated: September 26, 2011
Health Authority: Brazil: Ethics Committee

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

ClinicalTrials.gov processed this record on July 28, 2014