Corticosteroid Therapy on Glucose Control in Pregnant Women With Diabetes

This study has been completed.
Sponsor:
Information provided by:
The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT00673543
First received: May 5, 2008
Last updated: January 3, 2011
Last verified: January 2011

May 5, 2008
January 3, 2011
May 2008
September 2010   (final data collection date for primary outcome measure)
Time point at which glucose elevation occurs after glucocorticoid administration (greater than 50% increase in the patient's baseline blood) glucose level. [ Time Frame: Within 7 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00673543 on ClinicalTrials.gov Archive Site
  • Time at which glucose normalization occurs (ability to achieve glucose level within 20% of the patient's baseline blood glucose level) [ Time Frame: 7 days ] [ Designated as safety issue: No ]
  • The change in glucose in incremental amounts (every 4, 6, and 8 hour intervals) over time. [ Time Frame: 7 days ] [ Designated as safety issue: No ]
  • The amount of insulin needed to achieve targeted glucose levels over time [ Time Frame: 7 days ] [ Designated as safety issue: No ]
  • Total amount of insulin as well as incremental amounts of insulin every (4, 6, and 8 hour intervals) [ Time Frame: 7 days ] [ Designated as safety issue: No ]
  • Maternal age [ Time Frame: 7 days ] [ Designated as safety issue: No ]
  • Maternal body mass index [ Time Frame: 7 days ] [ Designated as safety issue: No ]
  • Gestational age [ Time Frame: 7 days ] [ Designated as safety issue: No ]
  • Hemoglobin A1C [ Time Frame: 7 days ] [ Designated as safety issue: No ]
  • Pre-corticosteroid insulin amount [ Time Frame: 7 days ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Corticosteroid Therapy on Glucose Control in Pregnant Women With Diabetes
The Effects of Corticosteroid Therapy on Glucose Control in Pregnant Women With Insulin Requiring Diabetes Mellitus

Preterm birth occurs in 25% of women with insulin requiring diabetes in pregnancy. The administration of corticosteroid therapy to accelerate fetal lung maturation is indicated in women at risk for preterm birth. The purpose of this study is to compare the timing, duration and severity of maternal hyperglycemia after corticosteroid administration in women with insulin-requiring diabetes compared to those without diabetes in pregnancy.

This is a prospective, observational study. Hourly glucose levels will be obtained for a total of 7 days after corticosteroid administration using the Dexcom Seven continuous glucose monitoring system. In addition, hemoglobin A1C will be obtained to assess the overall level of glycemic control of the participant prior to the corticosteroid therapy.

Preterm birth occurs in 25% of women with insulin requiring diabetes in pregnancy. The administration of corticosteroid therapy to accelerate fetal lung maturation is indicated in women at risk for preterm birth. Although corticosteroid therapy significantly decreases the risk for respiratory distress syndrome in the newborn, such therapy can lead to transient elevations in maternal glucose levels, potentially resulting in life-threatening maternal metabolic abnormalities, low oxygen levels in the fetus, and in extreme cases, stillbirth. Because the elevations in glucose levels may drastically increase over a short period of time, intense monitoring of maternal glucose levels to achieve strict glycemic control and treatment is preferred with the use of insulin. The purpose of this study is to compare the timing, duration and severity of maternal hyperglycemia after corticosteroid administration in women with insulin-requiring diabetes compared to those without diabetes in pregnancy.

This is a prospective, observational study. Hourly glucose levels will be obtained for a total of 7 days after corticosteroid administration using the Dexcom Seven continuous glucose monitoring system. In addition, hemoglobin A1C will be obtained to assess the overall level of glycemic control of the participant prior to the corticosteroid therapy.

The study group will include pregnant women > 18 years of age with insulin-requiring diabetes who will receive corticosteroid therapy to accelerate fetal lung maturation between 24 and 34 weeks of pregnancy. Only those women not in active labor and with singleton gestations will be included. A control group will be comprised of pregnant women with singleton gestations without insulin-requiring diabetes who will receive corticosteroid therapy also to accelerate fetal lung maturation.

Women will be excluded if they have diet controlled diabetes, twins or higher gestation, are in active labor and anticipate imminent delivery, were previously on any form of steroid therapy, or who have or will be receiving beta-adrenergic medications.

Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

Pregnant women who will receive corticosteroid therapy.

Pregnant Women
Not Provided
  • 1
    Pregnant women with insulin requiring diabetes
  • 2
    Pregnant women without insulin requiring diabetes
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16
September 2010
September 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • The study group will include pregnant women > 18 years of age with insulin-requiring diabetes who will receive corticosteroid therapy to accelerate fetal lung maturation between 24 and 34 weeks of pregnancy. Only those women not in active labor and with singleton gestations will be included. A control group will be comprised of pregnant women with singleton gestations without insulin-requiring diabetes who will receive corticosteroid therapy also to accelerate fetal lung maturation.

Exclusion Criteria:

  • Women will be excluded if they have diet controlled diabetes, twins or higher gestation, are in active labor and anticipate imminent delivery, were previously on any form of steroid therapy, or who have or will be receiving beta-adrenergic medications.
Female
18 Years to 52 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00673543
HSC-MS-08-0074
No
Jerrie S. Refuerzo, M.D., University of Texas Health Science Center at Houston
The University of Texas Health Science Center, Houston
Not Provided
Principal Investigator: Jerrie S Refuerzo, M.D. The University of Texas Health Science Center, Houston
The University of Texas Health Science Center, Houston
January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP