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Purpose

The purpose of this study is to develop an implementation protocol and test the feasibility and acceptability of a first trimester screening protocol for the early detection of gestational diabetes mellitus (GDM).

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 1) age greater than or equal to 18 years old, - 2) singleton gestation less than or equal to 12 weeks at initial obstetric visit, - 3) receiving prenatal care at UMMHC and plans to deliver at UMMHC, - 4) able and willing to provide informed consent, - 5) English or Spanish speaking, and - 6) are at high risk for developing GDM by ACOG clinical risk factor guidelines.

Exclusion Criteria

  • 1) known diagnosis of pre-existing pregestational diabetes, - 2) plan to receive prenatal care or deliver outside of UMMHC, - 3) inability to complete oral glucose tolerance test (e.g. gastric bypass surgery history, gastric dumping syndrome history, vomiting of oral glucose tolerance test), or - 4) systemic steroid use.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
This is a prospective, single-center, randomized study evaluating an early screening protocol for identifying women at high risk for developing GDM to the routine standard of care for GDM screening.
Primary Purpose
Screening
Masking
Single (Outcomes Assessor)
Masking Description
Those assessing the outcomes from the medical chart will be blinded to the randomization process and the assigned study arm. Patients, the primary investigator, and their care providers will be aware of their treatment status.

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Enhanced First Trimester GDM Screening 		Women who are randomly assigned to this condition will be required to have early glucose screening with a prediction model composed of additional clinical risk factors and serum biomarkers (triglycerides, PAPP-A, and lipocalin-2) with their initial prenatal laboratory assessment.
  • Diagnostic Test: Enhanced First Trimester GDM Screening
    Women who are randomly assigned to this condition will be required to have early glucose screening with a prediction model composed of additional clinical risk factors and serum biomarkers (triglycerides, PAPP-A, and lipocalin-2) with their initial prenatal laboratory assessment.
Active Comparator
Standard of Care GDM Screening 		Women who will be randomized to the comparison condition of usual standard of care will undergo routine standard of care. The standard of care will consist of routine screening for diabetes in pregnancy between 24 to 28 weeks of gestation via the two-step screening method with possible early screening with either plasma fasting glucose, oral glucose tolerance test, or hemoglobin A1c at the providers discretion to represent true clinical practice.
  • Diagnostic Test: Routine Gestational Diabetes Screening
    Women who will be randomized to the comparison condition of usual standard of care will undergo routine standard of care. The standard of care will consist of routine screening for diabetes in pregnancy between 24 to 28 weeks of gestation via the two-step screening method with possible early screening with either plasma fasting glucose, oral glucose tolerance test, or hemoglobin A1c at the providers discretion to represent true clinical practice.
    Other names:
    • Third Trimester Screening

Recruiting Locations

University of Massachusetts Memorial Medical Center
Worcester, Massachusetts 01605
Contact:
Gianna L Wilkie, MD
508-334-4067
Gianna.Wilkie@umassmemorial.org

More Details

Status
Recruiting
Sponsor
University of Massachusetts, Worcester

Study Contact

Gianna L Wilkie, MD
77743642523
Gianna.Wilkie@umassmemorial.org

Detailed Description

Gestational diabetes mellitus (GDM) is an important contributor to both maternal and neonatal morbidity and mortality in pregnancy. GDM has lifelong complications including an increased risk of developing type 2 diabetes mellitus and cardiovascular disease for women, and their offspring are at higher risk of being obese and also having diabetes in childhood and adolescence. Approximately 1 in 8 pregnancies is impacted by gestational diabetes mellitus worldwide. First trimester GDM screening is varied due to conflicting national guidelines, and the best strategy is unknown. The goal of the proposed research is to develop an implementation protocol and test the feasibility and acceptability of a first trimester screening protocol for the early detection of GDM. The investigators will utilize a pilot randomized controlled trial to recruit 80 high-risk pregnant women in the first trimester, of whom half will receive protocolized early GDM screening with serum biomarkers before 12 weeks and the remaining half will receive the current standard of care with screening between 24 and 28 weeks of gestation with possible early screening based on provider discretion.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.