The Effect of Steroids on Maternal Glucose Levels

NCT ID: NCT03021837

Last Updated: 2017-11-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-08-24
• Study Completion Date: 2015-03-17

Brief 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.

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.

Conditions

Gestational Diabetes

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: RETROSPECTIVE

Study Groups

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)

antenatal corticosteroid

Intervention Type: OTHER

Will look at maternal glucose level after corticosteroids

Interventions

antenatal corticosteroid

Will look at maternal glucose level after corticosteroids

Intervention Type: OTHER

Eligibility Criteria

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

• 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

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

St. Louis University

OTHER

Sponsor Role: lead

Responsible Party

Dorothea Mostello, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dorothea Mostello, MD

Role: PRINCIPAL_INVESTIGATOR

St. Louis University

Other Identifiers

21014a

Identifier Type: -

Identifier Source: org_study_id

NCT02912091

Identifier Type: -

Identifier Source: nct_alias