Immediate Postpartum Screening for Diabetes Mellitus in Women With Gestational Diabetes.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Pediatrix
- Enrollment
- 21
- Locations
- 1
- Primary Endpoint
- Sensitivity of early postpartum overt diabetes screening by 2-hour glucose tolerance testing in postpartum women.
Study Overview
Brief Summary
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.
Detailed Description
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).
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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 .
Outcomes
Primary Outcomes
Sensitivity of early postpartum overt diabetes screening by 2-hour glucose tolerance testing in postpartum women.
Time Frame: 24-48 hours postpartum verses 6-12 weeks postpartum.
We will compare the sensitivity of a 2-hour oral glucose tolerance test (2HR OGTT) for the detection of overt diabetes when performed within 48 hours of delivery ("early") among postpartum women previously diagnosed with gestational diabetes requiring treatment. The "early" 2HR OGTT result will be compared to the current standard of care of a 2HR OGTT performed at 6-12 weeks postpartum.
Secondary Outcomes
No secondary outcomes reported