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CompletedNCT03021837Updated Nov 22, 2017

The Effect of Steroids on Maternal Glucose Levels

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

Study type
Observational
Model
Other
Time perspective
Retrospective
Enrollment
200
Ages
14 Years to 50 Years
Sex
Female
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Study 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 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:

  1. 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.
  2. 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.
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Conditions studied

  • Gestational Diabetes

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03

In context

Diabetes, Gestational

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 →

Lead sponsor

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.

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Who can participate

Ages eligible
14 Years to 50 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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.

Inclusion criteria

  • 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)

Exclusion criteria

Exclusion Criteria:

  • 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
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Study design

Observational model
Other
Time perspective
Retrospective
Enrollment
200 participants (actual)
Patient registry
No

Groups and cohorts

  • 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)

    Other: antenatal corticosteroid

Interventions

  • Otherantenatal corticosteroid

    Will look at maternal glucose level after corticosteroids

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What researchers measure

Primary outcomes

  1. The length of time that maternal glucose levels remain elevated after steroid administration.

    Time until glucose levels return to baseline

    Time frame: 6 hours

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Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Aug 2012 to primary completion in Mar 2015, 30 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 11, 2017
First posted
Jan 16, 2017
StartActual
Aug 24, 2012
Primary completionActual
Mar 17, 2015
CompletionActual
Mar 17, 2015
Last update
Nov 22, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 22, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03021837
Responsible party
Dorothea Mostello, MD (Principal Investigator, St. Louis University) — Principal investigator
First posted
Jan 16, 2017
Start date
Aug 24, 2012
Primary completion
Mar 17, 2015
Completion
Mar 17, 2015
Last update
Nov 22, 2017

Study contacts

Dorothea Mostello, MD
principal investigator · St. Louis University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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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