Early Detection Screening for Gestational Diabetes
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to improve early detection of gestational diabetes, a condition that can develop during pregnancy and affect both mother and baby. Researchers are testing a new screening method called Enhanced First Trimester GDM Screening, which includes additional health factors and blood markers compared to the usual screening done later in pregnancy. Women who are less than 12 weeks pregnant and at high risk for gestational diabetes, according to health guidelines, might be suitable candidates for this trial. The goal is to determine if this early screening is practical and accepted by expecting mothers. As an unphased trial, this study offers participants a unique opportunity to contribute to groundbreaking research that could lead to better health outcomes for mothers and babies.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. However, if you are using systemic steroids, you cannot participate in the trial.
What prior data suggests that this screening protocol is safe for early detection of gestational diabetes?
Research shows that early testing for gestational diabetes (GDM) is safe for pregnant women. Studies have found that detecting GDM early helps manage blood sugar levels sooner, reducing risks for both mothers and babies. This process involves simple blood tests and checking for certain risk factors.
The tests used in early screening are generally easy to handle, with no reports of serious side effects. Early screening is important because it can catch problems early, helping to prevent complications later in pregnancy. Overall, research suggests that early GDM screening is safe and beneficial.12345Why are researchers excited about this trial?
Researchers are excited about the Enhanced First Trimester GDM Screening because it offers a proactive approach to detecting gestational diabetes earlier than the current standard. Unlike the usual practice that screens for diabetes between 24 to 28 weeks into pregnancy, this method uses a prediction model in the first trimester that considers additional clinical risk factors and specific serum biomarkers like triglycerides, PAPP-A, and lipocalin-2. By identifying potential diabetes risks earlier, this technique has the potential to improve health outcomes for both mothers and their babies by allowing for earlier intervention and management.
What evidence suggests that the Enhanced First Trimester GDM Screening is effective for early detection of gestational diabetes?
Research has shown that early screening for gestational diabetes (GDM) can be very beneficial. In this trial, participants will be randomized into different screening approaches. One group will undergo Enhanced First Trimester GDM Screening, which uses a new method that early tests have found GDM in 35% to 74% of cases, depending on individual risk factors. The other group will receive Standard of Care GDM Screening. Detecting GDM early is crucial because it helps manage issues like high blood pressure and larger babies. Early detection allows doctors to start treatments sooner, improving health outcomes for both mother and baby.36789
Who Is on the Research Team?
Gianna L Wilkie, MD
Principal Investigator
University of Massachusetts Chan Medical School
Are You a Good Fit for This Trial?
This trial is for pregnant women at high risk of gestational diabetes, aged 18 or older, who are receiving care and plan to deliver at UMMHC. They must be less than 12 weeks into a single pregnancy and speak English or Spanish. Women with pre-existing diabetes, steroid use, plans to receive care outside UMMHC, or unable to complete glucose tests cannot join.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Early GDM Screening
Participants undergo early glucose screening with a prediction model composed of additional clinical risk factors and serum biomarkers before 12 weeks of gestation
Standard GDM Screening
Participants receive routine screening for diabetes in pregnancy between 24 to 28 weeks of gestation via the two-step screening method
Follow-up
Participants are monitored for safety and effectiveness after screening, including assessment of patient satisfaction with the diabetes screening method
What Are the Treatments Tested in This Trial?
Interventions
- Enhanced First Trimester GDM Screening
- Routine Gestational Diabetes Screening
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Massachusetts, Worcester
Lead Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator