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Trial record 12 of 272 for:    Betamethasone

Continuous Glucose Monitoring in Pregnant Women Undergoing Betamethasone Therapy

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ClinicalTrials.gov Identifier: NCT01165775
Recruitment Status : Completed
First Posted : July 20, 2010
Results First Posted : September 16, 2016
Last Update Posted : September 16, 2016
Sponsor:
Information provided by (Responsible Party):
Yasser Yehia El-Sayed, Stanford University

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Pregnancy Complications
Intervention Device: Dexcom Seven Plus Continuous Glucose Monitoring System
Enrollment 17
Recruitment Details Women receiving clinically indicated betamethasone between 24 and 34 weeks of pregnancy were recruited from the labor and delivery setting.
Pre-assignment Details  
Arm/Group Title Threatened Pre Term Labor Patients
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Patients receiving betamethasone to minimize the complications of prematurity will monitor blood glucose levels using the Dexcom Seven Plus Continuous Glucose Monitoring System.

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.

Period Title: Overall Study
Started 17
Completed 15
Not Completed 2
Arm/Group Title Threatened Pre Term Labor Patients
Hide Arm/Group Description

Patients receiving betamethasone to minimize the complications of prematurity will monitor blood glucose levels using the Dexcom Seven Plus Continuous Glucose Monitoring System.

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.

Data are available for 15 of 17 participants.

Overall Number of Baseline Participants 15
Hide Baseline Analysis Population Description
Women receiving clinically indicated betamethasone between 24 and 34 weeks of pregnancy. Data are available for 15 of 17 participants.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 15 participants
30  (5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
Female
15
 100.0%
Male
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
Hispanic or Latino
9
  60.0%
Not Hispanic or Latino
6
  40.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
American Indian or Alaska Native
0
   0.0%
Asian
1
   6.7%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
3
  20.0%
White
10
  66.7%
More than one race
1
   6.7%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 15 participants
15
Gestational age at enrollment  
Mean (Full Range)
Unit of measure:  Weeks
Number Analyzed 15 participants
29.29
(25.14 to 34.0)
1.Primary Outcome
Title Percentage Time Spent Above Glucose Thresholds (>110;>144;>180) 24-48 Hours Post Betamethasone Treatment
Time Frame 24-48 hours post betamethasone treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Seventeen women were enrolled at the time of betamethasone administration and data were available for 15 patients.
Arm/Group Title Non-Diabetic Threatened Pre Term Labor Patients Diabetic Threatened Pre Term Labor Patients
Hide Arm/Group Description:

Patients receiving betamethasone to minimize the complications of prematurity will monitor blood glucose levels using the Dexcom Seven Plus Continuous Glucose Monitoring System.

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.

Patients receiving betamethasone to minimize the complications of prematurity will monitor blood glucose levels using the Dexcom Seven Plus Continuous Glucose Monitoring System.

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.

Overall Number of Participants Analyzed 11 4
Mean (Standard Deviation)
Unit of Measure: percentage time
mean (SD)% time with blood glucose > 110 73  (6) 79  (20)
mean (SD)% time with blood glucose > 144 40  (17) 58  (26)
mean (SD)% time with blood glucose > 180 17  (13) 24  (13)
2.Secondary Outcome
Title Neonatal Hypoglycemia
Hide Description [Not Specified]
Time Frame birth to discharge
Hide Outcome Measure Data
Hide Analysis Population Description
Neonates from birth to discharge. The maternal patients received betamethasone to minimize the complications of prematurity. Maternal blood glucose levels were monitored using the Dexcom Seven Plus Continuous Glucose Monitoring System.
Arm/Group Title Neonates With Hypoglycemia Neonates Without Hypoglycemia Neonates With Unknown Hypoglycemia Status
Hide Arm/Group Description:
Neonates with hypoglycemia from birth to hospital discharge.
Neonates without hypoglycemia from birth to hospital discharge.
Neonates with unknown hypoglycemia status from birth to hospital discharge.
Overall Number of Participants Analyzed 4 6 5
Measure Type: Number
Unit of Measure: participants
Maternal Diabetes 2 2 0
No Maternal Diabetes 2 4 5
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Neonates With Hypoglycemia, Neonates Without Hypoglycemia, Neonates With Unknown Hypoglycemia Status
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2155
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Threatened Pre Term Labor Patients
Hide Arm/Group Description

Patients receiving betamethasone to minimize the complications of prematurity will monitor blood glucose levels using the Dexcom Seven Plus Continuous Glucose Monitoring System.

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.

All-Cause Mortality
Threatened Pre Term Labor Patients
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Threatened Pre Term Labor Patients
Affected / at Risk (%)
Total   0/17 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Threatened Pre Term Labor Patients
Affected / at Risk (%)
Total   0/17 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Yasser El-Sayed, MD
Organization: Stanford School of Medicine
Phone: (650) 723-3198
EMail: Yasser.el-sayed@stanford.edu
Publications of Results:
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
Layout table for additonal information
Responsible Party: Yasser Yehia El-Sayed, Stanford University
ClinicalTrials.gov Identifier: NCT01165775     History of Changes
Other Study ID Numbers: SU-07082010-6490
18962 ( Other Identifier: Stanford University IRB )
First Submitted: July 16, 2010
First Posted: July 20, 2010
Results First Submitted: May 11, 2016
Results First Posted: September 16, 2016
Last Update Posted: September 16, 2016