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Early Detection Screening for Gestational Diabetes

N/A

Waitlist Available

Led By Gianna Wilkie, MD

Research Sponsored by University of Massachusetts, Worcester

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age greater than or equal to 18 years old

Singleton gestation less than or equal to 12 weeks at initial obstetric visit

Must not have

Systemic steroid use

Inability to complete oral glucose tolerance test (e.g. gastric bypass surgery history, gastric dumping syndrome history, vomiting of oral glucose tolerance test)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up in pregnancy (24-28 weeks gestation)

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new way to detect gestational diabetes earlier in pregnancy.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

There may not be direct side effects from participating as this trial involves screening methods rather than medication. However, there could be discomfort or other minor issues related to taking the oral glucose tolerance test.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I am pregnant with one baby and less than 12 weeks along.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently taking steroids.

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

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I was diagnosed with diabetes before getting pregnant.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at birth

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at birth

This trial's timeline: 3 weeks for screening, Varies for treatment, and at birth for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Gestational Diabetes Mellitus

Secondary study objectives

APGAR Score

Gestational Age at Delivery

Mode of Delivery

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Enhanced First Trimester GDM ScreeningExperimental Treatment1 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 ScreeningActive Control1 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.

0 / 5Eligibility criteria met