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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up in pregnancy (24-28 weeks gestation)

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Gestational Diabetes Mellitus

Secondary outcome measures

APGAR Score

Gestational Age at Delivery

Mode of Delivery

+5 more

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 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Massachusetts, WorcesterLead Sponsor

342 Previous Clinical Trials

976,530 Total Patients Enrolled

Gianna Wilkie, MDPrincipal InvestigatorUniversity of Massachusetts Chan Medical School

1 Previous Clinical Trials

40 Total Patients Enrolled

Media Library

Enhanced First Trimester GDM Screening Clinical Trial Eligibility Overview. Trial Name: NCT05388643 — N/A

Pregnancies Research Study Groups: Standard of Care GDM Screening, Enhanced First Trimester GDM Screening

Pregnancies Clinical Trial 2023: Enhanced First Trimester GDM Screening Highlights & Side Effects. Trial Name: NCT05388643 — N/A

Enhanced First Trimester GDM Screening 2023 Treatment Timeline for Medical Study. Trial Name: NCT05388643 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are new participants still being sought for this clinical trial?

"As per clinicaltrials.gov, no patients are being sought for this medical investigation at present; the study was initially posted on July 1st 2023 and recently updated on October 31st 2022. Nevertheless, 1220 other trials currently require participants to join them in their research efforts."

Answered by AI

Recent research and studies

Fetal Diagnosis and TherapyJournal

A Novel Early Pregnancy Risk Prediction Model for Gestational Diabetes Mellitus

Sweeting, Arianne N., Jencia Wong, Heidi Appelblom, Glynis P. Ross, Heikki Kouru, Paul F. Williams, Mikko Sairanen, and Jon A. Hyett. 2018. “A Novel Early Pregnancy Risk Prediction Model for Gestational Diabetes Mellitus”. Fetal Diagnosis and Therapy. S. Karger AG. doi:10.1159/000486853.

Prenatal DiagnosisJournal

Prediction of Gestational Diabetes Mellitus by Maternal Factors and Biomarkers at 11 to 13 Weeks

Nanda, Surabhi, Mina Savvidou, Argyro Syngelaki, Ranjit Akolekar, and Kypros H. Nicolaides. 2010. “Prediction of Gestational Diabetes Mellitus by Maternal Factors and Biomarkers at 11 to 13 Weeks”. Prenatal Diagnosis. Wiley. doi:10.1002/pd.2636.

clinicaltrials.govStudy

Early Detection of Gestational Diabetes Mellitus in Pregnancy

Gianna Wilkie 2024. "Early Detection of Gestational Diabetes Mellitus in Pregnancy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05388643.