The Effect of Steroids on Maternal Glucose Levels

NCT03021837 | Completed

• 1 other identifier: 21014a
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Gestational Diabetes

Outcome Measures

Primary Outcomes (1)

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

  Time until glucose levels return to baseline

  6 hours

Study Arms (1)

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

antenatal corticosteroid OTHER

Will look at maternal glucose level after corticosteroids

all patients

Eligibility Criteria

• Age: 14 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant patients, who meet Inclusion/exclusion criteria

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• St. Louis University: lead

MeSH Terms

Conditions

Diabetes, Gestational

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Dorothea Mostello, MD

  St. Louis University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 11, 2017
• First Posted: January 16, 2017
• Study Start: August 24, 2012
• Primary Completion: March 17, 2015
• Study Completion: March 17, 2015
• Last Updated: November 22, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share