Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

GDM Post Partum Screening

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03946631
Recruitment Status : Recruiting
First Posted : May 10, 2019
Last Update Posted : December 9, 2020
Sponsor:
Collaborator:
Banner University Medical Center
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Diabetes Gestational Diabetes Diabetes Mellitus, Type 2 Diagnostic Test: 2 hour glucose tolerance test using 75g glucose drink Not Applicable

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).

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Immediate Postpartum Screening for Diabetes Mellitus in Women With Gestational Diabetes.
Actual Study Start Date : August 20, 2019
Estimated Primary Completion Date : December 1, 2021
Estimated Study Completion Date : September 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Postpartum Care
Drug Information available for: Dextrose

Arm Intervention/treatment
Blood Glucose Test - 2hour GTT
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.
Diagnostic Test: 2 hour glucose tolerance test using 75g glucose drink
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.
Other Name: fingerstick testing




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   pregnant females with current diagnosis of type 2 DM or gestational diabetes
Accepts Healthy Volunteers:   No
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 .

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03946631


Contacts
Layout table for location contacts
Contact: Ana Bodea Braescu, MSN, MPH, RN 602-614-0488 ana_braescu@mednax.com
Contact: Michael Leovic, MD 480-969-5999 michael_leovic@mednax.com

Locations
Layout table for location information
United States, Arizona
Banner - University Medical Center Phoenix Recruiting
Phoenix, Arizona, United States, 85006
Contact: Ana Braescu, RN    602-257-8118    ana_braescu@mednax.com   
Contact: RN         
Principal Investigator: Kisti Fuller, MD         
Sponsors and Collaborators
Mednax Center for Research, Education, Quality and Safety
Banner University Medical Center
Investigators
Layout table for investigator information
Study Director: Laura Wilkes Banner University Medical Center
Principal Investigator: Kisti Fuller, MD Phoenix Perinatal Associates, Mednax
Publications:
5. Biljok VR, Bozicevic S, Lovrencic MV, Car N. Performance of the StatStrip Glucose Meter in Inpatient Management of Diabetes Mellitus. Diabetologia Croatica 2010; 39-3:105-109.

Layout table for additonal information
Responsible Party: Mednax Center for Research, Education, Quality and Safety
ClinicalTrials.gov Identifier: NCT03946631    
Other Study ID Numbers: GDM 2019 iris 01-18-0028
First Posted: May 10, 2019    Key Record Dates
Last Update Posted: December 9, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes, Gestational
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pregnancy Complications