Continuous Glucose Monitoring in Pregnant Women Undergoing Betamethasone Therapy

Completed

• Conditions: Pregnancy Complications
• Interventions: Device: Dexcom Seven Plus Continuous Glucose Monitoring System

• Registration Number: NCT01165775
• Lead Sponsor: Stanford University

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2010-07
• Study First Submitted: 2010-07-16
• Study First Submitted QC: 2010-07-16
• Study First Posted: 2010-07-20
• Primary Completion: 2014-06
• Study Completion: 2014-12
• Results First Submitted: 2016-05-11
• Status Verified: 2016-07
• Results First Submitted QC: 2016-07-28
• Last Update Submitted: 2016-07-28
• Results First Posted: 2016-09-16
• Last Update Posted: 2016-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 17

Inclusion Criteria

• 18 years of age or older

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

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Exclusion Criteria

• Less than 18 years old.

• Major fetal anomalies
• Use of steroid medications in the past 2 weeks.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Threatened pre term labor patients	Dexcom Seven Plus Continuous Glucose Monitoring System	Patients receiving betamethasone to minimize the complications of prematurity will monitor blood glucose levels using the Dexcom Seven Plus Continuous Glucose Monitoring System.

Primary Outcome Measures

Name	Time	Method
Percentage Time Spent Above Glucose Thresholds (>110;>144;>180) 24-48 Hours Post Betamethasone Treatment	24-48 hours post betamethasone treatment	During a 24 hour monitoring period (24-48 hours post betamethasone treatment), which percentage of the time was spent above glucose thresholds (\>110;\>144;\>180)

Secondary Outcome Measures

Name	Time	Method
Neonatal Hypoglycemia	birth to discharge

Trial Locations

Locations (1)

Stanford University School of Medicine; 🇺🇸 Stanford, California, United States