Gestational Diabetes MellitusPhase 2NCT01441518
Home Versus Hospital Care in Glucose Monitoring of Gestational Diabetes and Mild Gestational Hyperglycemia
A Phase 2 study testing Home care and Hospital care in people with Gestational Diabetes Mellitus and Pregestational Diabetes Mellitus, run by UPECLIN HC FM Botucatu Unesp at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Gestational Diabetes Mellitus, Pregestational Diabetes Mellitus, Mild Gestational Hyperglycemia
- What is being tested?
- Home care and Hospital care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteBrazil
- Study dates
- May 2010to Nov 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
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- 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.
Who cannot join
- Twin pregnancy diagnosed until the date of randomization or;
- Fetal malformation diagnosed until the date of randomization.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Faculdade de Medicina de Botucatu, Universidade Estadual Paulista
Botucatu, São Paulo, 18618-970
About this study
Official title: A Prospective Randomized Trial of 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.
- Conditions
- Gestational Diabetes Mellitus, Pregestational Diabetes Mellitus, Mild Gestational Hyperglycemia
- Being tested
- Home care, Hospital care
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home careOther
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 careOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Home care | Experimental | Not described Receives: Other: Home care |
| Hospital care | Active comparator | Not described Receives: Other: Hospital care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal mortality and morbidity rates
Measured: participants will be followed regarding maternal and perinatal mortality and morbidity rates up to six weeks postnatal
Perinatal mortality and morbidity rates
Measured: 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)
Measured: 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)
Measured: participants will be followed for maternal hospitalizations for any causes and prolonged hospitalization up to six weeks postnatal
Infants repeated hospitalizations
Measured: infants will be followed for repeated hospitalizations up to six weeks postnatal
Infants acute care visits
Measured: infants will be followed for acute care visits up to six weeks postnatal
Length of stay for delivery
Measured: participants will be followed for length of stay for delivery, an expected average of 9 months
Maternal prenatal and postpartum acute care visits
Measured: participants will be followed for maternal prenatal and postpartum acute care visits up to six weeks postnatal
Biophysical profile tests
Measured: participants will be followed for biophysical profile tests up to six weeks postnatal
Incidence of premature infants
Measured: participants will be followed regarding incidence of premature infants up to six weeks postnatal
Postpartum repeated hospitalization
Measured: participants will be followed for Postpartum repeated hospitalization up to six weeks postnatal
Glucose control
Measured: participants will be followed for glucose control up to six weeks postnatal
Costs
Measured: costs will be assessed for an expected average of 9 months from the time of randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2011 (estimated)
- Study startMay 2010
- Primary completionJan 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- UPECLIN HC FM Botucatu Unesp
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Silvana Andrea Molina Lima, UPECLIN HC FM Botucatu Unesp
- Investigators
- Dr Regina El Dib, PhD, Study director, UPECLIN HC FM Botucatu UnespDr Marilza Rudge, PhD, Principal investigator, UPECLIN HC FM Botucatu Unesp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01441518
- Sponsor's protocol ID
- upeclin/HC/FMB-Unesp-52
- Status last verified
- Sep 2011
- First submitted
- 31 May 2011
- Last updated
- 8 Jul 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Trial of Home Versus Hospital Care in Glucose Monitoring of Gestational Diabetes and Mild Gestational Hyperglycemia
- ClinicalTrials.gov ID
- NCT01441518
- Acronym / sponsor ID
- upeclin/HC/FMB-Unesp-52
- Conditions
- Gestational Diabetes Mellitus, Pregestational Diabetes Mellitus, Mild Gestational Hyperglycemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- UPECLIN HC FM Botucatu UnespUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Jan 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 27 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Home care | Experimental | Other: Home care |
| Hospital care | Active comparator | Other: Hospital care |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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:
- 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
Key exclusion criteria (2 listed)
- Twin pregnancy diagnosed until the date of randomization or;
- Fetal malformation diagnosed until the date of randomization.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home careHome 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 . | Other | Home care |
| Hospital careHospital 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. | Other | Hospital care |
Primary outcome
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
11 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr Regina El Dib, PhD study director
UPECLIN HC FM Botucatu Unesp
Dr Marilza Rudge, PhD principal investigator
UPECLIN HC FM Botucatu Unesp
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Home care and Hospital care in people with Gestational Diabetes Mellitus and Pregestational Diabetes Mellitus, run by UPECLIN HC FM Botucatu Unesp at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maternal mortality and morbidity rates (time frame: participants will be followed regarding maternal and perinatal mortality and morbidity rates up to six weeks postnatal). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2015; AzTrials last refreshed its copy on 8 Nov 2026.