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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/24/2021.

GDM Post Partum Screening

Clinicaltrials.gov identifier NCT03946631

Recruitment Status Recruiting

First Posted May 10, 2019

Last update posted August 22, 2019

Study Description

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:Diabetes
    Gestational Diabetes
    Diabetes Mellitus, Type 2
  • Intervention/Treatment: Diagnostic Test: 2 hour glucose tolerance test using 75g glucose drink
  • Phase: N/A
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: Interventional
  • Estimated Enrollment: 150 participants
  • 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 2019
  • Estimated Primary Completion Date: June 2021
  • Estimated Study Completion Date: September 2021
Arms and interventions
Arm Intervention/treatment
Other: 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.
Outcome Measures
  • 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.
Eligibility Criteria
  • Ages Eligible for Study: 18 to 60 Years (Adult)
  • Sexes Eligible for Study: 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 .

Contacts and Locations

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


United States, Arizona
Banner - University Medical Center Phoenix

Sponsors and Collaborators

Mednax Center for Research, Education, Quality and Safety

Banner University Medical Center


Study Director: Laura Wilkes Banner University Medical Center

Principal Investigator: Kisti Fuller, MD Phoenix Perinatal Associates, Mednax

More Information