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Gestational DiabetesNCT03021837

The Effect of Steroids on Maternal Glucose Levels

An observational study of Gestational Diabetes, run by St. Louis University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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:

  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.
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 groups in NCT03021837
Study groupRoleWhat they receive
all patientsPatient 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.

  1. 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.

  1. First posted16 Jan 2017 (estimated)
  2. Study start24 Aug 2012
  3. Primary completion17 Mar 2015
  4. Study completion17 Mar 2015

Resources

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)
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

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.

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