Ignite Creation Date:
2024-05-06 @ 12:19 AM
Last Modification Date:
2024-10-26 @ 10:47 AM
Study NCT ID:
NCT01540396
Status:
COMPLETED
Last Update Posted:
2016-02-04
First Post:
2012-02-15
Brief Title:
Gestational Diabetes Diagnostic Methods
Sponsor:
University of Pittsburgh
Organization:
University of Pittsburgh
Study Overview
Official Title:
GD2M StudyGestational Diabetes Diagnostic Methods
Status:
COMPLETED
Status Verified Date:
2016-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GD2M
Brief Summary:
This is a pilot feasibility study of 40 pregnant women to test the investigators recruitment enrollment and randomization procedures in preparation to conduct a larger randomized control trial to compare diagnostic methods for gestational diabetes The two methods that are being compared are the 2 hour 75 gram OGGT 2011 ADA guidelines versus a 1 hour 50 gram GCT 3 hour 100 gram OGTT if the 1 hour result is abnormal Carpenter and Coustan criteria
Detailed Description:
This is a pilot feasibility study of 40 pregnant women between 24-28 weeks gestation to test the investigators recruitment enrollment and randomization procedures in preparation to conduct a larger randomized control trial to compare diagnostic methods for gestational diabetes
Forty women 18 years of age or older will be recruited at 20-24 weeks pregnancy from the obgyn outpatient practices at Magee-Womens hospital MWH Eligible women will return to MWH main lab between 24-28 weeks gestation for the routine 1 hour 50gm glucose challenge test Women with blood glucose values less than 200 will be randomized to receive either the fasting 2 hour 75 gm oral glucose tolerance test OGTTor the 3 hour 100 gm OGGT within two weeks Gestational diabetes will be determined for the 2 hour 75 gm OGGT arm based on the 2011 ADA guidelines and the 3 hour 100 gm OGGT arm based on the Carpenter and Coustan criteria Patients and their providers will be informed of the diagnosis of gestational diabetes but they will be blinded to the criteria used to make the diagnosis as well as the specific results of glucose tolerance testing
Chart reviews will be conducted to assess for perinatal maternal and infant health factors egpregnancy weight gestational weight gain co morbidities as well as for data on perinatal outcomes related to GDM such as macrosomia c-sections and birth trauma Two brief self-administered questionnaire will assess participants views on screening for gestational diabetes and assess participants experience with and solicit feedback on the study procedures
At the end of this pilot study the investigators will have experience with recruitment retention and randomization procedures and have made the necessary protocol revisions If successful this feasibility study will provide the preliminary data and feasibility justification needed to conduct a larger randomized control trial to compare the effectiveness of two diagnostic methods for gestational diabetes
Forty women 18 years of age or older will be recruited at 20-24 weeks pregnancy from the obgyn outpatient practices at Magee-Womens hospital MWH Eligible women will return to MWH main lab between 24-28 weeks gestation for the routine 1 hour 50gm glucose challenge test Women with blood glucose values less than 200 will be randomized to receive either the fasting 2 hour 75 gm oral glucose tolerance test OGTTor the 3 hour 100 gm OGGT within two weeks Gestational diabetes will be determined for the 2 hour 75 gm OGGT arm based on the 2011 ADA guidelines and the 3 hour 100 gm OGGT arm based on the Carpenter and Coustan criteria Patients and their providers will be informed of the diagnosis of gestational diabetes but they will be blinded to the criteria used to make the diagnosis as well as the specific results of glucose tolerance testing
Chart reviews will be conducted to assess for perinatal maternal and infant health factors egpregnancy weight gestational weight gain co morbidities as well as for data on perinatal outcomes related to GDM such as macrosomia c-sections and birth trauma Two brief self-administered questionnaire will assess participants views on screening for gestational diabetes and assess participants experience with and solicit feedback on the study procedures
At the end of this pilot study the investigators will have experience with recruitment retention and randomization procedures and have made the necessary protocol revisions If successful this feasibility study will provide the preliminary data and feasibility justification needed to conduct a larger randomized control trial to compare the effectiveness of two diagnostic methods for gestational diabetes
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None