NCT06457139 · University of Massachusetts, Worcester
Preventing T2DM After GDM With Immediate Postpartum Screening
What this study is about
The overall goal of this proposal is to create and test an implementation protocol for in-hospital immediate postpartum diabetes screening for postpartum patients with pregnancies affected by GDM.
View original scientific description
The overall goal of this proposal is to create and test an implementation protocol for in-hospital immediate postpartum diabetes screening for postpartum patients with pregnancies affected by GDM.
Interventions
DIAGNOSTIC_TEST
Glucose tolerance test (2 hour)
Early testing with the 2 hour glucose tolerance test will occur during their inpatient postpartum hospitalization.
OTHER
Active Comparator
Subjects randomized to the comparison condition will receive the usual standard of care. The standard of care will consist of administration of educational materials adapted from the American Diabetes Association that discusses healthy lifestyle behaviors and the increased risks of developing T2DM after a pregnancy complicated by GDM.
Primary outcome measures
Detection of Type 2 Diabetes Mellitus
Time frame: At time of postpartum screening (postpartum day 1 or 6 week postpartum visit pending randomization arm)
Detection of Type 2 Diabetes Mellitus by 2 hour oral glucose tolerance test
Glycemic Outcomes--Hemoglobin A1c
Time frame: at time of postpartum screening (postpartum day 1 or 6 week postpartum visit pending randomization arm)
Serum blood measurement of hemoglobin A1c
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- pregnancy complicated by GDM as diagnosed with traditional two step testing in the third trimester according to Carpenter-Coustan Criteria
- receiving prenatal care at UMASS Memorial and plans to deliver at UMASS Memorial
- able and willing to provide informed consent
- ability to complete immediate in hospital postpartum glucose testing
- have evidence of impaired glucose metabolism defined as fasting glucose value of ≥126 mg/dL or 2-hour glucose value of ≥200 mg/dL
Exclusion criteria
- known diagnosis of pre-existing pre-gestational diabetes in pregnancy
- inability to complete oral glucose tolerance test (e.g. gastric bypass surgery history, gastric dumping syndrome history, vomiting of oral glucose tolerance test) in pregnancy or immediately postpartum
- systemic steroid use
Where
- Worcester, Massachusetts
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 24, 2026 · Source of record for eligibility and locations