Clinical trial NCT00673543: Corticosteroid Therapy on Glucose Control in Pregnant Women With Diabetes
Official title: The Effects of Corticosteroid Therapy on Glucose Control in Pregnant Women With Insulin Requiring Diabetes Mellitus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnant Women
Keywords: Corticosteroids
Pregnancy
Glucose control
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2008-05-07
Enrollment: 16
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 52
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pregnant women who will receive corticosteroid therapy.

Brief summary: 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.

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 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.

Primary outcomes:
measure: Time point at which glucose elevation occurs after glucocorticoid administration (greater than 50% increase in the patient's baseline blood) glucose level.
timeFrame: Within 7 days
Secondary outcomes:
measure: Time at which glucose normalization occurs (ability to achieve glucose level within 20% of the patient's baseline blood glucose level)
timeFrame: 7 days
measure: The change in glucose in incremental amounts (every 4, 6, and 8 hour intervals) over time.
timeFrame: 7 days
measure: The amount of insulin needed to achieve targeted glucose levels over time
timeFrame: 7 days
measure: Total amount of insulin as well as incremental amounts of insulin every (4, 6, and 8 hour intervals)
timeFrame: 7 days
measure: Maternal age
timeFrame: 7 days
measure: Maternal body mass index
timeFrame: 7 days
measure: Gestational age
timeFrame: 7 days
measure: Hemoglobin A1C
timeFrame: 7 days
measure: Pre-corticosteroid insulin amount
timeFrame: 7 days
Other outcomes:
Locations:
city: Houston
country: United States
facility: Lyndon B. Johnson Hospital
state: Texas
city: Houston
country: United States
facility: Memorial Hermann Hospital Texas Medical Center
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Jerrie S Refuerzo, M.D.
role: PRINCIPAL_INVESTIGATOR
References: