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.
Studieoversikt
Status
Forhold
Detaljert beskrivelse
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
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
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Texas
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Houston, Texas, Forente stater, 77030
- Memorial Hermann Hospital Texas Medical Center
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Houston, Texas, Forente stater, 77026
- Lyndon B. Johnson Hospital
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
|---|
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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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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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.
Tidsramme: Within 7 days
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Within 7 days
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Time at which glucose normalization occurs (ability to achieve glucose level within 20% of the patient's baseline blood glucose level)
Tidsramme: 7 days
|
7 days
|
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The change in glucose in incremental amounts (every 4, 6, and 8 hour intervals) over time.
Tidsramme: 7 days
|
7 days
|
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The amount of insulin needed to achieve targeted glucose levels over time
Tidsramme: 7 days
|
7 days
|
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Total amount of insulin as well as incremental amounts of insulin every (4, 6, and 8 hour intervals)
Tidsramme: 7 days
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7 days
|
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Maternal age
Tidsramme: 7 days
|
7 days
|
|
Maternal body mass index
Tidsramme: 7 days
|
7 days
|
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Gestational age
Tidsramme: 7 days
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7 days
|
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Hemoglobin A1C
Tidsramme: 7 days
|
7 days
|
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Pre-corticosteroid insulin amount
Tidsramme: 7 days
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7 days
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Samarbeidspartnere og etterforskere
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- HSC-MS-08-0074
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