Early screening to find gestational diabetes in pregnancy
Early Detection of Gestational Diabetes Mellitus in Pregnancy: A Randomized Trial
This project tries a first-trimester blood screening to see if it finds gestational diabetes earlier in pregnant people at high risk.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University of Massachusetts, Worcester Academic / other |
| Locations | 1 site (Worcester, Massachusetts) |
| Trial ID | NCT05388643 on ClinicalTrials.gov |
What this trial studies
Gestational diabetes increases risks for both mothers and newborns and is typically screened for in the second trimester. This pilot randomized controlled trial will enroll 80 high-risk pregnant people before 12 weeks at UMass Memorial; half will receive a protocolized first-trimester serum biomarker screen and half will receive standard screening at 24–28 weeks with possible early screening at provider discretion. The study will test the feasibility and acceptability of implementing early screening and compare timing of detection and related maternal and neonatal outcomes. Investigators will use clinical data and participant feedback to refine the protocol for potential broader use.
Who should consider this trial
Good fit: Pregnant people aged 18 or older with a singleton pregnancy at or before 12 weeks, receiving prenatal care and planning delivery at UMMHC, who meet ACOG high-risk criteria and speak English or Spanish are ideal candidates.
Not a fit: People with preexisting diabetes, those unable to complete an oral glucose tolerance test, those on systemic steroids, or those planning care outside UMMHC are unlikely to benefit.
Why it matters
Potential benefit: If successful, earlier detection could allow earlier treatment and monitoring to reduce pregnancy and newborn complications.
How similar studies have performed: Prior work on first-trimester biomarker screening for gestational diabetes has shown mixed results, so this pilot focuses on feasibility and implementation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 1\) age greater than or equal to 18 years old, * 2\) singleton gestation less than or equal to 12 weeks at initial obstetric visit, * 3\) receiving prenatal care at UMMHC and plans to deliver at UMMHC, * 4\) able and willing to provide informed consent, * 5\) English or Spanish speaking, and * 6\) are at high risk for developing GDM by ACOG clinical risk factor guidelines. Exclusion Criteria: * 1\) known diagnosis of pre-existing pregestational diabetes, * 2\) plan to receive prenatal care or deliver outside of UMMHC, * 3\) inability to complete oral glucose tolerance test (e.g. gastric bypass surgery history, gastric dumping syndrome history, vomiting of oral glucose tolerance test), or * 4\) systemic steroid use.
Where this trial is running
Worcester, Massachusetts
- University of Massachusetts Memorial Medical Center — Worcester, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Gianna Wilkie, MD — University of Massachusetts, Worcester
- Study coordinator: Gianna L Wilkie, MD
- Email: Gianna.Wilkie@umassmemorial.org
- Phone: 77743642523
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.