GDM Post Partum Screening

Immediate Postpartum Screening for Diabetes Mellitus in Women With Gestational Diabetes.

Sponsors

Lead Sponsor: Mednax Center for Research, Education, Quality and Safety

Collaborator: Banner University Medical Center

Source Mednax Center for Research, Education, Quality and Safety
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).

Overall Status Recruiting
Start Date August 20, 2019
Completion Date September 1, 2021
Primary Completion Date June 1, 2021
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Sensitivity of early postpartum overt diabetes screening by 2-hour glucose tolerance testing in postpartum women. 24-48 hours postpartum verses 6-12 weeks postpartum.
Enrollment 150
Condition
Intervention

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

Eligibility

Criteria:

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 .

Gender: Female

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

Overall Official
Overall Contact

Last Name: Ana Bodea Braescu, MSN, MPH, RN

Phone: 602-614-0488

Email: ana[email protected]

Location
Facility: Status: Contact: Contact Backup: Investigator: Banner - University Medical Center Phoenix Ana Braescu, RN 602-257-8118 [email protected] Kisti Fuller, MD Principal Investigator
Location Countries

United States

Verification Date

August 2019

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: Blood Glucose Test - 2hour GTT

Type: Other

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.

Patient Data No
Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Primary Purpose: Screening

Masking: None (Open Label)

Source: ClinicalTrials.gov