GDM Post Partum Screening
Immediate Postpartum Screening for Diabetes Mellitus in Women With Gestational Diabetes.
Collaborator: Banner University Medical Center
|Source||Mednax Center for Research, Education, Quality and Safety|
Immediate postpartum screening for diabetes mellitus in women with gestational diabetes
The objective of this study is to determine if screening for type 2 diabetes can be done 24 hours after delivery, versus 6-12 weeks postpartum, in recently delivered women having been diagnosed with gestational diabetes requiring medication therapy in the antecedent pregnancy.
1 Overview The purpose of the project is to determine if screening for diabetes mellitus, in women with gestational diabetes, can be done 24 hours postpartum versus 6-12 weeks postpartum.
Primary Objective: To compare the results from screening for type 2 diabetes 24 hours postpartum versus 6-12 weeks postpartum.
Design and Project Type Prospective cohort study. Women diagnosed with gestational diabetes and receiving anti-hyperglycemic medication therapy will have testing for type 2 DM done 24 hours after delivery. They will also have routine screening for type 2 DM done at 6-12 weeks postpartum.
Description of Intervention The intervention is early screening for type 2 DM which involves oral intake of a 75-- gram (g) glucose drink and subsequent measurement of fasting, 1- hour, and 2- hour postprandial point of care fingerstick s for blood glucose measurement.
Instruments Fingerstick testing will be done with StatStrip Glucose Hospital Meter (Nova Biomedical). This device is used routinely throughout the hospital and has been validated for use in all patients, including the critically ill. Using point of care testing will allow for accurate results with less pain for the patient, as compared to (fingerstick versus venipuncture).
|Start Date||August 20, 2019|
|Completion Date||September 1, 2021|
|Primary Completion Date||June 1, 2021|
Intervention Type: Diagnostic Test
Intervention Name: 2 hour glucose tolerance test using 75g glucose drink
Description: intervention is a 2 hour glucose tolerance test. Involves oral intake of a 75g glucose drink followed by using point of care testing. Glucose drink is taken after at least 6 hours of fasting. Fingerstick blood glucose testing done at three time points: fasting, one hour post drink and two hours post drink.
Arm Group Label: Blood Glucose Test - 2hour GTT
Other Name: fingerstick testing
Inclusion Criteria: - Pregnant, or recently postpartum, women with the diagnosis of GDM requiring medication therapy after 20 weeks, - >18 years-old (yo)yo, - English speaking. Exclusion Criteria: - have pre-existing type 2 DM, - did not require anti-hyperglycemic medication therapy (GDMA1), - early onset GDM (<20 weeks). - do not speak English .
- Pregnant, or recently postpartum, women with the diagnosis of GDM requiring medication therapy after 20 weeks,
- >18 years-old (yo)yo,
- English speaking.
- have pre-existing type 2 DM,
- did not require anti-hyperglycemic medication therapy (GDMA1),
- early onset GDM (<20 weeks).
- do not speak English .
Gender Based: Yes
Gender Description: pregnant females with current diagnosis of type 2 DM or gestational diabetes
Minimum Age: 18 Years
Maximum Age: 60 Years
Healthy Volunteers: No
Last Name: Ana Bodea Braescu, MSN, MPH, RN
Email: ana[email protected]
|Has Expanded Access||No|
|Number Of Arms||1|
Label: Blood Glucose Test - 2hour GTT
Description: Only one arm: intervention group. The intervention is fasting 2 hour glucose tolerance test in the immediate postpartum period. The screening test consists of fingerstick blood glucose testing after a glucose drink. First, a fasting blood glucose finger stick will be performed. Second, the glucose drink is orally ingested containing 75g glucose. The drink is to be orally ingested over 60 seconds. Lastly, fingerstick blood glucose testing is completed at 1 hour post drink and 2 hours post drink.
|Study Design Info||
Intervention Model: Single Group Assignment
Primary Purpose: Screening
Masking: None (Open Label)