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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
  Purpose

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.


Condition
Pregnant Women

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: The Effects of Corticosteroid Therapy on Glucose Control in Pregnant Women With Insulin Requiring Diabetes Mellitus

Resource links provided by NLM:


Further study details as provided by The University of Texas Health Science Center, Houston:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 16
Study Start Date: May 2008
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Pregnant women with insulin requiring diabetes
2
Pregnant women without insulin requiring diabetes

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 52 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Pregnant women who will receive corticosteroid therapy.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00673543

Locations
United States, Texas
Lyndon B. Johnson Hospital
Houston, Texas, United States, 77026
Memorial Hermann Hospital Texas Medical Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Investigators
Principal Investigator: Jerrie S Refuerzo, M.D. The University of Texas Health Science Center, Houston
  More Information

No publications provided

Responsible Party: Jerrie S. Refuerzo, M.D., University of Texas Health Science Center at Houston
ClinicalTrials.gov Identifier: NCT00673543     History of Changes
Other Study ID Numbers: HSC-MS-08-0074
Study First Received: May 5, 2008
Last Updated: January 3, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by The University of Texas Health Science Center, Houston:
Corticosteroids
Pregnancy
Glucose control

ClinicalTrials.gov processed this record on November 24, 2014