Early Detection Screening for Gestational Diabetes

Overseen By Gianna L Wilkie, MD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Massachusetts, Worcester

Must not be taking: Systemic steroids

Disqualifiers: Pregestational diabetes, Others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

80 Participants Needed

Trial Summary

What is the purpose of this trial?

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).

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 data supports the effectiveness of the treatment Enhanced First Trimester GDM Screening for early detection of gestational diabetes?

Research shows that early screening for gestational diabetes can identify a significant number of women with the condition before 20 weeks of pregnancy, especially in high-risk groups. However, the benefits of early detection and treatment are still debated, and more studies are needed to confirm its effectiveness in improving pregnancy outcomes. ^{1 2 3 4 5}

Is early gestational diabetes screening safe for pregnant women?

Early gestational diabetes screening is generally considered safe, but there is limited evidence on its benefits and potential harms. Some studies suggest that early screening may lead to a higher chance of preterm birth, but more research is needed to fully understand the safety and effectiveness of early screening. ^{1 2 3 6 7}

How does the Enhanced First Trimester GDM Screening treatment differ from other treatments for gestational diabetes?

The Enhanced First Trimester GDM Screening treatment is unique because it focuses on early detection of gestational diabetes in the first trimester using fasting plasma glucose levels, which is earlier than the traditional screening at 24-28 weeks. This approach aims to identify and manage gestational diabetes sooner, potentially improving outcomes for both the mother and baby. ^{6 8 9 10 11}

Research Team

Gianna L Wilkie, MD

Principal Investigator

University of Massachusetts Chan Medical School

Eligibility Criteria

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

Receiving prenatal care at UMMHC and plans to deliver at UMMHC

Able and willing to provide informed consent

You have a high risk of developing gestational diabetes according to ACOG clinical risk factor guidelines.

Exclusion Criteria

Plan to receive prenatal care or deliver outside of UMMHC

I am currently taking steroids.

I cannot complete an oral glucose test due to past surgeries or conditions.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

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

Up to 12 weeks

Standard GDM Screening

Participants receive routine screening for diabetes in pregnancy between 24 to 28 weeks of gestation via the two-step screening method

24-28 weeks gestation

Follow-up

Participants are monitored for safety and effectiveness after screening, including assessment of patient satisfaction with the diabetes screening method

Postpartum day 1 after birth

Treatment Details

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.

Participant Groups

Group I: Enhanced First Trimester GDM Screening Experimental Treatment 1 Intervention

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.

Group II: Standard of Care GDM Screening Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

University of Massachusetts, Worcester

Lead Sponsor

Trials

372

Recruited

998,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

Screening and Treatment for Early-Onset Gestational Diabetes Mellitus: a Systematic Review and Meta-analysis. [2022]

2. Germany pubmed.ncbi.nlm.nih.gov

Impact of earlier gestational diabetes screening for pregnant people with obesity on maternal and perinatal outcomes. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Impact of Early Screening for Gestational Diabetes on Perinatal Outcomes in High-Risk Women. [2018]

4. England pubmed.ncbi.nlm.nih.gov

Early universal screening of gestational diabetes in a university hospital in Thailand. [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Screening for Gestational Diabetes Mellitus in Early Pregnancy: What Is the Evidence? [2021]

6. Ireland pubmed.ncbi.nlm.nih.gov

First trimester fasting hyperglycemia as a predictor for the development of gestational diabetes mellitus. [2022]

7. France pubmed.ncbi.nlm.nih.gov

[Is there a standard biological screening of gestational diabetes mellitus?]. [2021]

8. New Zealand pubmed.ncbi.nlm.nih.gov

An Update on Screening Strategies for Gestational Diabetes Mellitus: A Narrative Review. [2023]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Controversies in Screening and Diagnostic Criteria for Gestational Diabetes in Early and Late Pregnancy. [2019]

10. Canada pubmed.ncbi.nlm.nih.gov

Gestational diabetes mellitus identification based on self-monitoring of blood glucose. [2015]

11. France pubmed.ncbi.nlm.nih.gov

Correspondence between first-trimester fasting glycaemia, and oral glucose tolerance test in gestational diabetes diagnosis. [2022]