The Effect of Steroids for Fetal Lung Maturity on Maternal Glucose Levels

Gestational Diabetes Clinical Trial

Official title:

The Effect of Steroids for Fetal Lung Maturity on Maternal Glucose Levels

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02912091
• Other study ID #: 21014
• Status: Completed
• Phase: N/A
• First received: September 21, 2016
• Last updated: September 7, 2017
• Start date: August 2012
• Est. completion date: January 2014

Study information

• Verified date: September 2017
• Source: St. Louis University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 sugar elevation following steroids.

Description:

The investigators hypothesize that maternal glucose levels will be elevated in the first 72 hours after steroid administration, and that the magnitude of the peak will be predictive of a diagnosis of gestational diabetes. This is a retrospective chart review.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 14 Years to 50 Years

Eligibility

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 W-omen 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

Related Conditions & MeSH terms

• Diabetes, Gestational
• Gestational Diabetes

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
St. Louis University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time	To determine the length of time that maternal glucose levels remain elevated after steroid administration.	length of time that maternal glucose levels remain elevated
Secondary	Peak glucose levels	To determine when the peak glucose levels occur, the magnitude of the peak glucose, and whether either predicts a future diagnosis of gestational diabetes	varies
Secondary	Diet controlled	To determine the corresponding response of blood glucose for patients with known gestational diabetes who are currently diet-controlled and if diagnosis of gestational diabetes can be made based upon the maternal response to steroid administration.	varies
Secondary	Newborn	To determine any effects of maternal glucose elevation on the newborn.	varies