GDM Post Partum Screening

December 12, 2022 updated by: Mednax Center for Research, Education, Quality and Safety

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

21

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • Banner - University Medical Center Phoenix

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 58 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Pregnant, or recently postpartum, women with the diagnosis of GDM requiring medication therapy after 20 weeks, >18 years-old (yo), English speaking

Description

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 .

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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 Names:
  • fingerstick testing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
24-48 hours postpartum verses 6-12 weeks postpartum.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mednax Center for Research, Education, Quality and Safety

Collaborators

Banner University Medical Center

Investigators

  • Study Director: Laura Wilkes, Banner University Medical Center
  • Principal Investigator: Kisti Fuller, MD, Phoenix Perinatal Associates, Mednax

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 20, 2019

Primary Completion (Actual)

October 21, 2022

Study Completion (Actual)

October 21, 2022

Study Registration Dates

First Submitted

April 15, 2019

First Submitted That Met QC Criteria

May 9, 2019

First Posted (Actual)

May 10, 2019

Study Record Updates

Last Update Posted (Estimate)

December 14, 2022

Last Update Submitted That Met QC Criteria

December 12, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GDM 2019 iris 01-18-0028

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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