Early screening to find gestational diabetes in pregnancy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• NOURISH: a community partnership to improve nutrition and glycemic control in pregnant women with pregestational diabetes

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• Behavioral toolkit to help pregnant women manage gestational diabetes and pregnancy-related high blood pressure.

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• MOCHA: Inpatient Mental Health Care for High-Risk Pregnancy

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• Early pregnancy lifestyle patterns and glucose changes in a TOFFFY sub-study

  This study tests whether daily patterns like sleep, activity, and meal timing in early pregnancy affect glucose levels and the risk of gestational diabetes, using CGM and wearable data in pregnant women in Singapore.

  Recruiting KK Women's and Children's Hospital · Singapore, Singapore · NCT07534670

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.