Corticosteroid Therapy on Glucose Control in Pregnant Women With Diabetes
Condition: Pregnant Women
Study type: Observational

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.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Pregnant women who will receive corticosteroid therapy.
      
Keywords: Corticosteroids; Pregnancy; Glucose control