Gestational DiabetesNCT03021837
The Effect of Steroids on Maternal Glucose Levels
An observational study of Gestational Diabetes, run by St. Louis University.
Trial summary
This study will look at blood sugar levels in pregnant women who have been given a glucocorticoid (steroid) medication to enhance fetal lung maturity. The findings will help determine the likelihood, predictive value, adverse effects, response of patients diagnosed with gestational diabetes and time course of blood… Read more about this study
- Who is it for?
- Ages 14 to 50 years, women only
- Conditions the study is for
- Gestational Diabetes
- What is being tested?
- antenatal corticosteroid
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 24 Aug 2012to 17 Mar 2015
- Phase
- Observational
- 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 14 to 50 years
- Women only
- No healthy volunteers
- Child, Adult
Study population: Pregnant patients, who meet Inclusion/exclusion criteria
Who may be able to join
- Intrauterine pregnancy at 22 weeks to 36 weeks gestation at time of steroid administration
- Singleton
- Patient receiving antenatal corticosteroid course for fetal lung maturity consisting of betamethasone or dexamethasone
- Age range: 14yo-50yo
- Women without known gestational diabetes and women with non-insulin requiring gestational diabetes (A1GDM)
Who cannot join
- Women with known gestational diabetes (diagnosed before steroid administration) that has required insulin or other medical therapy to control
- Women with overt diabetes which predates pregnancy.
- Chronic terbutaline therapy or other concurrent chronic beta-adrenergic agonist use
- Patients on parenteral or oral corticosteroids for reasons other than to improve fetal lung maturity
- Multiple gestation
About this study
Official title: The Effect of Steroids for Fetal Lung Maturity on Maternal Glucose Levels
This study will look at blood sugar levels in pregnant women who have been given a glucocorticoid (steroid) medication to enhance fetal lung maturity. The findings will help determine the likelihood, predictive value, adverse effects, response of patients diagnosed with gestational diabetes and time course of blood sugar elevation following steroids.
Read the detailed description
Few studies have examined the effects on maternal glucose levels from corticosteroids, which are given during some complicated pregnancies to enhance fetal lung maturity when early delivery is expected. The applicability of these studies is limited by the presence of confounding factors and low numbers of participants (ranging between 7 and 50). Two relevant studies are by Mastrobiattista at al and Gurbuz et al. These studies had 7 and 40 subjects respectively, and studied the change in maternal 1-hour glucose tolerance tests following administration of steroids for fetal lung maturity. The 1-hour tests involve a standard oral glucose challenge and are used to screen for gestational diabetes; thus, they may not reflect the changes in circulating glucose levels from typical sources of glucose (such as meals) anticipated with steroid administration. Both studies showed a change in the results of glucose tolerance testing and concluded that screening for gestational diabetes should be delayed at least 72 hours to 1 week after completion of the steroid course. Neither study looked at maternal glucose values within the first 48 hours of giving the first dose of steroids, and neither addressed whether diabetes could be diagnosed alternatively by the maternal glucose response within the first 48 hours following steroid administration.
It has been the investigator's clinical observation that glucose values may be highest during those first 48 hours. Another study looked at the effect of various doses of insulin on the degree of hyperglycemia for the first 3 days following steroid administration and showed increases in glucose values even in the insulin-treated. Unfortunately, some subjects in that study had concurrent treatment with another agent known to cause hyperglycemia.
No standards of care exist to guide whether to monitor glucose values after steroid administration for fetal lung maturity. The time course of glucose elevations is not clear, and how often the glucose elevations reach a level that would generally warrant treatment is unknown. When glucose monitoring is performed, no standard exists to guide the duration or frequency of monitoring.
Detecting maternal hyperglycemia is important for several reasons, including:
- High maternal glucose levels lead to high fetal levels and prompt a fetal response to the high glucose levels. Some of the pregnancies may go on to deliver while the maternal glucose levels are still high, resulting in a higher risk of neonatal hypoglycemia in the nursery and an increased risk of acidosis and injury in the brain if periods of distress occur during labor. By the nature of the clinical situations, most fetuses born in the first few days following administration of steroids will also be preterm and possibly already have additional factors which put them at risk for complications in labor and the nursery, so the hyperglycemia compounds the risk for them.
- The maternal hyperglycemia may complicate the maternal course at a time when the pregnant woman is receiving other medications to control her premature labor or obstetric condition that prompted the use of the steroids in the first place. Fluid balance and constitutional symptoms may be affected by high glucose values. Rarely, diabetic ketoacidosis may be precipitated in someone with no history of diabetes.
- Conditions
- Gestational Diabetes
- Being tested
- antenatal corticosteroid
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
antenatal corticosteroidOther
Will look at maternal glucose level after corticosteroids
| Study group | Role | What they receive |
|---|---|---|
| all patients | Patient receiving antenatal corticosteroid course for fetal lung maturity consisting of betamethasone or dexamethasone Women without known gestational diabetes and women with non-insulin requiring gestational diabetes (A1GDM) Receives: Other: antenatal corticosteroid |
What is being measured
The primary outcome is the main question the study is designed to answer.
The length of time that maternal glucose levels remain elevated after steroid administration.
Time until glucose levels return to baseline
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2017 (estimated)
- Study start24 Aug 2012
- Primary completion17 Mar 2015
- Study completion17 Mar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational DiabetesStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Louis University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dorothea Mostello, MD, St. Louis University
- Investigators
- Dorothea Mostello, MD, Principal investigator, St. Louis University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03021837
- Sponsor's protocol ID
- 21014a
- Status last verified
- Nov 2017
- First submitted
- 11 Jan 2017
- Last updated
- 22 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Steroids for Fetal Lung Maturity on Maternal Glucose Levels
- ClinicalTrials.gov ID
- NCT03021837
- Acronym / sponsor ID
- 21014a
- Conditions
- Gestational Diabetes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- St. Louis UniversityUniversity, hospital or other
- Study start
- 24 Aug 2012 (actual)
- Primary completion
- 17 Mar 2015 (actual)
- Study completion
- 17 Mar 2015 (actual)
- First posted
- 16 Jan 2017 (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.
This study will look at blood sugar levels in pregnant women who have been given a glucocorticoid (steroid) medication to enhance fetal lung maturity. The findings will help determine the likelihood, predictive value, adverse effects, response of patients diagnosed with gestational diabetes and time course of blood sugar elevation following steroids.
Detailed description
Few studies have examined the effects on maternal glucose levels from corticosteroids, which are given during some complicated pregnancies to enhance fetal lung maturity when early delivery is expected. The applicability of these studies is limited by the presence of confounding factors and low numbers of participants (ranging between 7 and 50). Two relevant studies are by Mastrobiattista at al and Gurbuz et al. These studies had 7 and 40 subjects respectively, and studied the change in maternal 1-hour glucose tolerance tests following administration of steroids for fetal lung maturity. The 1-hour tests involve a standard oral glucose challenge and are used to screen for gestational diabetes; thus, they may not reflect the changes in circulating glucose levels from typical sources of glucose (such as meals) anticipated with steroid administration. Both studies showed a change in the results of glucose tolerance testing and concluded that screening for gestational diabetes should be delayed at least 72 hours to 1 week after completion of the steroid course. Neither study looked at maternal glucose values within the first 48 hours of giving the first dose of steroids, and neither addressed whether diabetes could be diagnosed alternatively by the maternal glucose response within the first 48 hours following steroid administration.
It has been the investigator's clinical observation that glucose values may be highest during those first 48 hours. Another study looked at the effect of various doses of insulin on the degree of hyperglycemia for the first 3 days following steroid administration and showed increases in glucose values even in the insulin-treated. Unfortunately, some subjects in that study had concurrent treatment with another agent known to cause hyperglycemia.
No standards of care exist to guide whether to monitor glucose values after steroid administration for fetal lung maturity. The time course of glucose elevations is not clear, and how often the glucose elevations reach a level that would generally warrant treatment is unknown. When glucose monitoring is performed, no standard exists to guide the duration or frequency of monitoring.
Detecting maternal hyperglycemia is important for several reasons, including:
- High maternal glucose levels lead to high fetal levels and prompt a fetal response to the high glucose levels. Some of the pregnancies may go on to deliver while the maternal glucose levels are still high, resulting in a higher risk of neonatal hypoglycemia in the nursery and an increased risk of acidosis and injury in the brain if periods of distress occur during labor. By the nature of the clinical situations, most fetuses born in the first few days following administration of steroids will also be preterm and possibly already have additional factors which put them at risk for complications in labor and the nursery, so the hyperglycemia compounds the risk for them.
- The maternal hyperglycemia may complicate the maternal course at a time when the pregnant woman is receiving other medications to control her premature labor or obstetric condition that prompted the use of the steroids in the first place. Fluid balance and constitutional symptoms may be affected by high glucose values. Rarely, diabetic ketoacidosis may be precipitated in someone with no history of diabetes.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| all patients | – | Other: antenatal corticosteroidPatient receiving antenatal corticosteroid course for fetal lung maturity consisting of betamethasone or dexamethasone Women without known gestational diabetes and women with non-insulin requiring gestational diabetes (A1GDM) |
Who may qualify
- Ages
- 14 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Pregnant patients, who meet Inclusion/exclusion criteria
Key inclusion criteria (5 listed)
- Intrauterine pregnancy at 22 weeks to 36 weeks gestation at time of steroid administration
- Singleton
- Patient receiving antenatal corticosteroid course for fetal lung maturity consisting of betamethasone or dexamethasone
- Age range: 14yo-50yo
- Women without known gestational diabetes and women with non-insulin requiring gestational diabetes (A1GDM)
Key exclusion criteria (5 listed)
- Women with known gestational diabetes (diagnosed before steroid administration) that has required insulin or other medical therapy to control
- Women with overt diabetes which predates pregnancy.
- Chronic terbutaline therapy or other concurrent chronic beta-adrenergic agonist use
- Patients on parenteral or oral corticosteroids for reasons other than to improve fetal lung maturity
- Multiple gestation
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 |
|---|---|---|
| antenatal corticosteroidWill look at maternal glucose level after corticosteroids | Other | all patients |
Primary outcome
The length of time that maternal glucose levels remain elevated after steroid administration.
Time frame: 6 hours
Time until glucose levels return to baseline
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 22 Nov 2017.
- Individual participant dataSharing planned: No
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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.
Dorothea Mostello, MD principal investigator
St. Louis University
Questions about this trial
What is this clinical trial studying?
An observational study of Gestational Diabetes, run by St. Louis University.
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 5 inclusion and 5 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 22 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
The length of time that maternal glucose levels remain elevated after steroid administration. (time frame: 6 hours). 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 22 Nov 2017.