Continuous Glucose Monitoring in Pregnant Women Undergoing Betamethasone Therapy

Pregnancy Complications Clinical Trial

Official title:

Continuous Glucose Monitoring in Pregnant Women Undergoing Betamethasone Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01165775
• Other study ID #: SU-07082010-6490
• Secondary ID: 18962
• Status: Completed
• Phase: N/A
• First received: July 16, 2010
• Last updated: March 30, 2015
• Start date: July 2010
• Est. completion date: December 2014

Study information

• Verified date: March 2015
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: December 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Pregnancy Complications

Intervention

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.

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

References & Publications (1)

Maternal glucose response to betamethasone administration American Journal of Obstetrics and Gynecology, Volume 206, Issue 1, Page S98 Elizabeth Langen, Jessica Lewis, Joyce Sung, Mark Taslimi, James Byrne, Yasser El-Sayed

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Episodes of hyperglycemia		7 days from insertion of device	No
Secondary	Neonatal hypoglycemia		2 da	No

External Links

•   Maternal glucose response to betamethasone administration