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.
Studie Overzicht
Toestand
Conditie
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Contacten en locaties
Studie Locaties
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Texas
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Houston, Texas, Verenigde Staten, 77030
- Memorial Hermann Hospital Texas Medical Center
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Houston, Texas, Verenigde Staten, 77026
- Lyndon B. Johnson Hospital
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
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1
Pregnant women with insulin requiring diabetes
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2
Pregnant women without insulin requiring diabetes
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
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Time point at which glucose elevation occurs after glucocorticoid administration (greater than 50% increase in the patient's baseline blood) glucose level.
Tijdsspanne: Within 7 days
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Within 7 days
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Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
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Time at which glucose normalization occurs (ability to achieve glucose level within 20% of the patient's baseline blood glucose level)
Tijdsspanne: 7 days
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7 days
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The change in glucose in incremental amounts (every 4, 6, and 8 hour intervals) over time.
Tijdsspanne: 7 days
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7 days
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The amount of insulin needed to achieve targeted glucose levels over time
Tijdsspanne: 7 days
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7 days
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Total amount of insulin as well as incremental amounts of insulin every (4, 6, and 8 hour intervals)
Tijdsspanne: 7 days
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7 days
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Maternal age
Tijdsspanne: 7 days
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7 days
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Maternal body mass index
Tijdsspanne: 7 days
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7 days
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Gestational age
Tijdsspanne: 7 days
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7 days
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Hemoglobin A1C
Tijdsspanne: 7 days
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7 days
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Pre-corticosteroid insulin amount
Tijdsspanne: 7 days
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7 days
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Medewerkers en onderzoekers
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Andere studie-ID-nummers
- HSC-MS-08-0074
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