An observational study in Gestational Diabetes, sponsored by St. Louis University. Completed. Open to female participants aged 14 Years to 50 Years. Per ClinicalTrials.gov, last updated 2017-11-22.
Sponsored by St. Louis University · Observational
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.
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:
857 studies on the registry are indexed under Diabetes, Gestational; 199 are open to participants now.
This study's enrollment of 200 is close to the median of 198 across 274 observational studies indexed under Diabetes, Gestational.
Browse Diabetes, Gestational studies →St. Louis University is the lead sponsor of 156 studies on the registry; 17 are open to participants now.
Of its 19 completed or terminated interventional studies of FDA-regulated products, 15 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Pregnant patients, who meet Inclusion/exclusion criteria
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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)
Other: antenatal corticosteroid
Will look at maternal glucose level after corticosteroids
The length of time that maternal glucose levels remain elevated after steroid administration.
Time until glucose levels return to baseline
Time frame: 6 hours
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Ran from Aug 2012 to primary completion in Mar 2015, 30 months.
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This study is completed, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.
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