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
Trial Overview
The study is testing an early screening method for gestational diabetes in the first trimester compared to the routine screening later in pregnancy. The goal is to see if this new protocol can be implemented effectively and whether it's acceptable to patients.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
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.
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
Citations
Early Screening for Gestational Diabetes Mellitus and ...
The present systematic review therefore aims to determine whether screening for GDM in the first trimester (≤20 weeks) improves clinically ...
First‐Trimester Prediction of Gestational Diabetes Mellitus ...
In the assessment of risk by the new model, the overall detection of GDM was 35%, 52%, 65% and 74% at SPRs of 10%, 20%, 30% and 40%, ...
Detection and treatment of early gestational diabetes mellitus
To estimate the impact of detection and treatment of early gestational diabetes mellitus on short-term maternal, fetal, and neonatal ...
USPSTF Review: Screening for Gestational Diabetes
At or after 24 weeks of gestation, treatment of gestational diabetes was significantly associated with improved health outcomes.
5.
uptodate.com
uptodate.com/contents/gestational-diabetes-mellitus-screening-diagnosis-and-preventionGestational diabetes mellitus: Screening, diagnosis, and ...
Among the main consequences of GDM are increased risks of preeclampsia, large for gestational age (LGA) newborns, and cesarean birth, and their ...
Gestational Diabetes - StatPearls - NCBI Bookshelf
... GDM are at high risk for developing type 2 diabetes long-term and that antepartum GDM treatment reduces adverse pregnancy outcomes. However ...
Treatment of Gestational Diabetes Mellitus Diagnosed ...
In cohort studies, women with pregnancies complicated by early (<20 weeks' gestation) hyperglycemia showed accelerated fetal growth by 24 to 28 weeks' gestation ...
8.
diabetesjournals.org
diabetesjournals.org/care/article/48/Supplement_1/S306/157565/15-Management-of-Diabetes-in-Pregnancy-Standards15. Management of Diabetes in Pregnancy: Standards of Care ...
Observational studies in preexisting diabetes and pregnancy show the lowest rates of adverse fetal outcomes in association with A1C <6–6.5% (<42 ...
Gestational Diabetes Mellitus: Update on Screening ...
First-trimester screening can identify preexisting diabetes and early-onset GDM for prompt implementation of glucose control measures. Treatment of GDM has been ...
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