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NCT Number: NCT01441518

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.

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Faculdade de Medicina de Botucatu, Universidade Estadual Paulista

Botucatu, São Paulo, 18618-970, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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 .

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.

Primary outcomes

  1. Maternal mortality and morbidity rates

    Time frame: participants will be followed regarding maternal and perinatal mortality and morbidity rates up to six weeks postnatal

  2. 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 outcomes

  1. 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

  2. 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

  3. Infants repeated hospitalizations

    Time frame: infants will be followed for repeated hospitalizations up to six weeks postnatal

  4. Infants acute care visits

    Time frame: infants will be followed for acute care visits up to six weeks postnatal

  5. Length of stay for delivery

    Time frame: participants will be followed for length of stay for delivery, an expected average of 9 months

  6. 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

  7. Biophysical profile tests

    Time frame: participants will be followed for biophysical profile tests up to six weeks postnatal

  8. Incidence of premature infants

    Time frame: participants will be followed regarding incidence of premature infants up to six weeks postnatal

  9. Postpartum repeated hospitalization

    Time frame: participants will be followed for Postpartum repeated hospitalization up to six weeks postnatal

  10. Glucose control

    Time frame: participants will be followed for glucose control up to six weeks postnatal

  11. Costs

    Time frame: costs will be assessed for an expected average of 9 months from the time of randomization

Sponsors and collaborators

Lead sponsor

UPECLIN HC FM Botucatu Unesp

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Sep 27, 2011
Registry last updated
Jul 8, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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