An interventional study of Enhanced First Trimester GDM Screening and Routine Gestational Diabetes Screening in Gestational Diabetes Mellitus in Pregnancy and Pregnancy, High Risk, sponsored by University of Massachusetts, Worcester. Recruiting at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-06.
Sponsored by University of Massachusetts, Worcester · Not applicable, Interventional, and Screening
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).
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.
842 studies on the registry are indexed under Diabetes, Gestational; 199 are open to participants now.
This study's planned enrollment of 80 is below the median of 110 across 549 interventional studies indexed under Diabetes, Gestational.
Browse Diabetes, Gestational studies →University of Massachusetts, Worcester is the lead sponsor of 288 studies on the registry; 54 are open to participants now.
Of its 25 completed or terminated interventional studies of FDA-regulated products, 18 (72%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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 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 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.
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.
Also known as: Third Trimester Screening
Gestational Diabetes Mellitus
Confirmed diagnosis of GDM based on 3 hour 100 gram glucose tolerance test
Time frame: In pregnancy (24-28 weeks gestation)
Mode of Delivery
Mode of delivery (Vaginal versus Cesarean delivery)
Time frame: At Birth
Neonatal Birthweight
Neonatal Birthweight
Time frame: At Birth
Number of Participants with Shoulder Dystocia
Number of Participants with Shoulder Dystocia
Time frame: At Birth
Number of participants with brachial plexus injury
Number of participants with brachial plexus injury
Time frame: At Birth
APGAR Score
APGAR Score (range 0 to 10, with 10 being the best)
Time frame: At Birth
Neonatal Intensive Care Unit Admission
Admission to Level 2 or greater neonatal ICU and length of stay
Time frame: At delivery and within first 2 days of life
Gestational Age at Delivery
Gestational Age at Delivery
Time frame: At Birth
Patient Satisfaction with Diabetes Screening Method
This will be assessed by the Patient Satisfaction Survey questionnaire, which is scored out of 30, with 30 being the highest score)
Time frame: Postpartum day 1 after birth
Plan to share: No
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University of Massachusetts, Worcester