Enhanced First Trimester GDM Screening for Diabetes, Gestational

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of Massachusetts Memorial Medical Center, Worcester, MA
Diabetes, Gestational+4 More
Enhanced First Trimester GDM Screening - DiagnosticTest
Eligibility
18+
Female
What conditions do you have?
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Study Summary

This trial is testing a new way to detect gestational diabetes earlier in pregnancy. Enhanced First Trimester GDM Screening is a treatment for diabetes that is caused by pregnancy, and it is not a placebo. This treatment has been approved by the FDA in the past for another condition.

Eligible Conditions

  • Diabetes, Gestational
  • Pregnancy in Diabetics
  • High Risk Pregnancies

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 8 Secondary · Reporting Duration: At Birth

At Birth
APGAR Score
Gestational Age at Delivery
Mode of Delivery
Neonatal Birthweight
Number of Participants with Shoulder Dystocia
Number of participants with brachial plexus injury
Day 2
Neonatal Intensive Care Unit Admission
Week 28
Gestational Diabetes Mellitus
Day 1
Patient Satisfaction with Diabetes Screening Method

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Standard of Care GDM Screening
1 of 2
Enhanced First Trimester GDM Screening
1 of 2
Active Control
Experimental Treatment

80 Total Participants · 2 Treatment Groups

Primary Treatment: Enhanced First Trimester GDM Screening · No Placebo Group · N/A

Enhanced First Trimester GDM Screening
DiagnosticTest
Experimental Group · 1 Intervention: Enhanced First Trimester GDM Screening · Intervention Types: DiagnosticTest
Standard of Care GDM Screening
DiagnosticTest
ActiveComparator Group · 1 Intervention: Routine Gestational Diabetes Screening · Intervention Types: DiagnosticTest

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: at birth
Closest Location: University of Massachusetts Memorial Medical Center · Worcester, MA
Photo of massachusetts 1Photo of massachusetts 2Photo of massachusetts 3
2006First Recorded Clinical Trial
1 TrialsResearching Diabetes, Gestational
107 CompletedClinical Trials

Who is running the clinical trial?

University of Massachusetts, WorcesterLead Sponsor
306 Previous Clinical Trials
741,025 Total Patients Enrolled
1 Trials studying Diabetes, Gestational
40 Patients Enrolled for Diabetes, Gestational
Gianna Wilkie, MDPrincipal InvestigatorUniversity of Massachusetts Chan Medical School
1 Previous Clinical Trials
40 Total Patients Enrolled

Eligibility Criteria

Age 18+ · Female Participants · 6 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are at high risk for developing gestational diabetes mellitus by ACOG clinical risk factor guidelines.
You are eligible for the study if you are between the ages of 18 and 65 years old.
You are a singleton pregnancy less than or equal to 12 weeks at initial obstetric visit.
You are pregnant and you plan to deliver at UMMHC.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.