Continuous Glucose Monitoring in Pregnant Women Undergoing Betamethasone Therapy

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Yasser Yehia El-Sayed, Stanford University
ClinicalTrials.gov Identifier:
NCT01165775
First received: July 16, 2010
Last updated: May 22, 2013
Last verified: May 2013

July 16, 2010
May 22, 2013
July 2010
June 2014   (final data collection date for primary outcome measure)
Episodes of hyperglycemia [ Time Frame: 7 days from insertion of device ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01165775 on ClinicalTrials.gov Archive Site
Neonatal hypoglycemia [ Time Frame: 2 da ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Continuous Glucose Monitoring in Pregnant Women Undergoing Betamethasone Therapy
Continuous Glucose Monitoring in Pregnant Women Undergoing Betamethasone Therapy

We hope to clarify how betamethasone affects glucose levels in the mother in the days after receiving the drug. This understanding will hopefully allow us to better anticipate the risk of maternal hyperglycemia and therefore establish more appropriate monitoring of maternal glucose to prevent maternal and neonatal complications of hyperglycemia.

Pregnant patients who are undergoing inpatient betamethasone therapy as part of their clinical care will be eligible for the study. Once the clinical team and patients have agreed to pursue betamethasone therapy, the patients' treating physician or nurse will inquire if the patient is interested in participating in our study protocol. Those patients who are interested in participation will be consented by either a member of the treatment team or the study team. Prior to receiving the first betamethasone dose, a soft sensor for continuous glucose monitoring system (CGMS) will be inserted superficially under the skin. For those patients who will be receiving a scheduled course of betamethasone, the sensor may be inserted up to 24 hours prior to the betamethasone administration. The patient will be instructed on how to wear and care for the device. She will wear the CGMS for the duration of her hospitalization or for up to 7 days total, whichever time period is shorter. For those patients who are diabetic, they will receive normal finger stick blood glucose (FSBG) monitoring and insulin therapy as determined by their treating physicians. Those patients who are not diabetic will need to have 2 FSBG checks each day to correlate with the device. Abnormal values will be reported to the patients' treating physician and addressed by the treating physician. Prior to being discharged from the hospital, the patient will have the device removed. The patient will otherwise be treated routinely. We will record baseline demographic information and medical history from each of the women. We will also record information from the neonates' newborn medical records.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Pregnant women receiving betamethasone

Pregnancy Complications
Device: Dexcom Seven Plus Continuous Glucose Monitoring System
Soft sensor for continuous glucose monitoring inserted for up to 24 hours prior to administration of betamethasone. Device to be worn for duration of hospitalization or up to 7 days total, whichever time period is shorter.
Threatened pre term labor patients
Patients receiving betamethasone to minimize the complications of prematurity will monitor blood glucose levels using the Dexcom Seven Plus Continuous Glucose Monitoring System.
Intervention: Device: Dexcom Seven Plus Continuous Glucose Monitoring System
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
60
January 2015
June 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:- 18 years of age or older

  • Receiving betamethasone as part of routine clinical care.
  • Pregnancy between 23+5 and 35+0 weeks

Exclusion Criteria:- Less than 18 years old.

  • Major fetal anomalies
  • Use of steroid medications in the past 2 weeks.
Female
18 Years to 50 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01165775
SU-07082010-6490, 18962
No
Yasser Yehia El-Sayed, Stanford University
Stanford University
Not Provided
Principal Investigator: Yasser Yehia El-Sayed Stanford University
Stanford University
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP