Yasser El-Sayed, Professor
Correlation of Continuous Glucose Monitoring and Glucose Tolerance Testing with Pregnancy Outcomes
Contact Information
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Brief
Diabetic pregnant patients are at risk for adverse pregnancy outcomes, including larger than expected fetuses and unplanned operative deliveries, due to elevated blood glucose levels. the one-hour glucola test is currently used to screen pregnant patients for gestational diabetes. This involves ingesting a 50-gram glucose load, followed by a blood test one hour later. We wish to compare 7-day continuous glucose monitoring to the one-hour glucola test, and detremine which one correlates better with adverse pregnancy outcomes as well as which one more accurately identifies patients at risk for adverse pregnancy outcomes.
Recruiting Status:
RecruitingStanford Recruiting Status:
RecruitingCondition(s):
Intervention(s):
- Device: The Seven Continuous Glucose Monitoring System
Phase:
Phase 1/Phase 2Eligibility
Ages Eligible for Study:
18 years to 50 yearsGenders Eligible for Study:
FemaleHealth of Volunteers:
People with the conditions listed in this trial can participate as controls.Key Inclusion Criteria:
-Pregnant patients with no diagnosis of pre-existing diabetes
-Age 18-50
-Gestational age less than 28 weeks
Key Exclusion Criteria:
-Minors less than 18 years of age
-Multiple gestation
-Known fetal anomalies
-Pre-existing diabetes
-Prior cesarean section
-Planned cesarean section for delivery in current pregnancy
Additional Study Details
Official Title:
Correlation of Continuous Glucose Monitoring and Glucose Tolerance Testing with Pregnancy OutcomesAnticipated start date:
2/9/2009Lead Sponsor:
Stanford UniversityCollaborator(s):
- DexCom
Investigator(s):
Study Type:
InterventionalPurpose:
DiagnosticAllocation:
Non-randomizedMasking:
OpenControl:
noneAssignment:
Single GroupEndpoints:
EfficacyPrimary Outcomes:
- Birth weight centile
Secondary Outcomes:
- Unplanned operative deliveries
Total Number to be Enrolled:
230Total Number to be Enrolled at Stanford:
230More Information
Secondary ID(s):
- IRB #12335
Locations & Contacts
Stanford Locations & Contacts:
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Non-Stanford Locations:
This study is being conducted at multiple locations, including non-Stanford locations.
This listing was last updated:
8/24/2009PLEASE NOTE:
Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician. If you do not have a primary care physician please feel free to call the SHC Physician Referral Service at (800) 756-9000 or send an email.
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