A Novel Early Pregnancy Risk Prediction Model for Gestational Diabetes Mellitus.
Arianne N Sweeting, Jencia Wong, Heidi Appelblom...
https://pubmed.ncbi.nlm.nih.gov/29898442Actively Recruiting
Phase Not Applicable
Age: 18Years +
FEMALE
ID05388643
Early Detection of Gestational Diabetes Mellitus in Pregnancy: A Randomized Trial
Led by University of Massachusetts, Worcester · Updated on 2026-04-06
80
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of Massachusetts, Worcester
Lead Sponsor
E
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Gestational diabetes mellitus (GDM) is a common condition during pregnancy that can lead to serious health issues for both mothers and their babies. This trial aims to develop and test a protocol for early first trimester screening to detect GDM sooner than the standard practice. The study will compare early screening methods to the usual screening performed later in pregnancy to see which approach is more feasible and acceptable for patients. Participants will be randomly assigned to one of two groups. One group will receive early glucose screening before 12 weeks using a prediction model that includes clinical risk factors and serum biomarkers like triglycerides, PAPP-A, and lipocalin-2. The other group will follow the standard screening care, which occurs between 24 to 28 weeks of pregnancy and may include fasting glucose, oral glucose tolerance test, or hemoglobin A1c based on provider choice. Women will take part during their pregnancy with assessments including blood tests for GDM detection at the designated times. Researchers will monitor outcomes such as GDM diagnosis during 24-28 weeks, mode of delivery, newborn birth weight, birth complications, APGAR scores, and neonatal intensive care admissions. Patient satisfaction with the screening method will also be evaluated after birth. The study spans from the first trimester through delivery and postpartum assessments.
CONDITIONS
Brief Title
Early Detection of Gestational Diabetes Mellitus in Pregnancy
Who Can Participate
Age: 18Years +
FEMALE
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Singleton pregnancy less than or equal to 12 weeks at first prenatal visit
- Receiving prenatal care at University of Massachusetts Memorial Health Care and planning to deliver there
- Able and willing to provide informed consent
- English or Spanish speaking
- At high risk for developing gestational diabetes mellitus according to ACOG guidelines
You will not qualify if you...
- Known diagnosis of pre-existing diabetes before pregnancy
- Planning to receive prenatal care or deliver outside University of Massachusetts Memorial Health Care
- Unable to complete an oral glucose tolerance test (due to prior gastric surgery, dumping syndrome, or vomiting after the test)
- Current use of systemic steroids
AI-Screening
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Surveillance
Duration - From enrollment up to 28 weeks of pregnancy
Participants are observed with either early first trimester glucose screening using serum biomarkers or routine gestational diabetes screening between 24 and 28 weeks of pregnancy, depending on their randomized group assignment.
1 to 2 visits depending on screening timing
Long-term Monitoring
Duration - From delivery to postpartum day 1
Participants and their newborns are followed for health outcomes around delivery and shortly after birth.
1 visit at delivery and 1 postpartum visit
Trial Site Locations
Total: 1 location
1
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, United States, 01605
Actively Recruiting
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Research Team
G
Gianna L Wilkie, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SCREENING
Number of Arms
2
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Published Research Related To This Trial
Prediction of gestational diabetes mellitus by maternal factors and biomarkers at 11 to 13 weeks.
Surabhi Nanda, Mina Savvidou, Argyro Syngelaki...
https://pubmed.ncbi.nlm.nih.gov/21268030