A Prospective Randomized Trial of Home Versus Hospital Care in Glucose Monitoring of Gestational Diabetes and Mild Gestational Hyperglycemia
Sponsor study identifier
interventional
80
1 country
1
Study Start
May 2010
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
January 2013
Actual (reported)Study Completion
November 2013
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 2013
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 2010
Date type not reportedThis date has not been verified as actual or estimated.
May 31, 2011
Actual (reported)September 27, 2011
Actual (reported)January 2013
Actual (reported)November 2013
Actual (reported)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
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
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 .
Faculdade de Medicina de Botucatu, Universidade Estadual Paulista
Botucatu, São Paulo, 18618-970, Brazil
Dr Regina El Dib, PhD
UPECLIN HC FM Botucatu Unesp
Dr Marilza Rudge, PhD
UPECLIN HC FM Botucatu Unesp
80 participants (actual enrollment reported by the registry).
First Submitted
May 31, 2011
First Posted
September 27, 2011
Study Start
May 2010
Date type not reportedThis date has not been verified as actual or estimated.
DIAgnosing GDM usiNg Oral Sugar InStead
A Probiotic Based Intervention in Pregnancies Complicated by GDM
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
January 2013
Actual (reported)Study Completion
November 2013
Actual (reported)Last Updated
July 8, 2015
Record last verified: 2011-09
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: