Early Detection of Gestational Diabetes Mellitus in Pregnancy

NCT05388643 | Recruiting DMC FDA Device

• 2 other identifiers: STUDY00002047K23HD111526
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to develop an implementation protocol and test the feasibility and acceptability of a first trimester screening protocol for the early detection of gestational diabetes mellitus (GDM).

Conditions

Gestational Diabetes Mellitus in Pregnancy; Pregnancy, High Risk

Keywords

Pregnancy; Gestational Diabetes; Screening; Maternal Outcomes; Neonatal Outcomes

Outcome Measures

Primary Outcomes (1)

• Gestational Diabetes Mellitus

  Confirmed diagnosis of GDM based on 3 hour 100 gram glucose tolerance test

  In pregnancy (24-28 weeks gestation)

Secondary Outcomes (8)

• Mode of Delivery

  At Birth

• Neonatal Birthweight

  At Birth

• Number of Participants with Shoulder Dystocia

  At Birth

• Number of participants with brachial plexus injury

  At Birth

• APGAR Score

  At Birth

Study Arms (2)

Enhanced First Trimester GDM Screening

EXPERIMENTAL

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.

Diagnostic Test: Enhanced First Trimester GDM Screening

Standard of Care GDM Screening

ACTIVE COMPARATOR

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.

Diagnostic Test: Routine Gestational Diabetes Screening

Interventions

Enhanced First Trimester GDM Screening DIAGNOSTIC_TEST

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.

Enhanced First Trimester GDM Screening

Routine Gestational Diabetes Screening DIAGNOSTIC_TEST

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.

Also known as: Third Trimester Screening

Standard of Care GDM Screening

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) age greater than or equal to 18 years old,
• \) singleton gestation less than or equal to 12 weeks at initial obstetric visit,
• \) receiving prenatal care at UMMHC and plans to deliver at UMMHC,
• \) able and willing to provide informed consent,
• \) English or Spanish speaking, and
• \) are at high risk for developing GDM by ACOG clinical risk factor guidelines.

You may not qualify if:

• \) known diagnosis of pre-existing pregestational diabetes,
• \) plan to receive prenatal care or deliver outside of UMMHC,
• \) inability to complete oral glucose tolerance test (e.g. gastric bypass surgery history, gastric dumping syndrome history, vomiting of oral glucose tolerance test), or
• \) systemic steroid use.

Sponsors & Collaborators

• University of Massachusetts, Worcester: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

University of Massachusetts Memorial Medical Center

Worcester, Massachusetts, 01605, United States

RECRUITING

Related Publications (2)

• Sweeting AN, Wong J, Appelblom H, Ross GP, Kouru H, Williams PF, Sairanen M, Hyett JA. A Novel Early Pregnancy Risk Prediction Model for Gestational Diabetes Mellitus. Fetal Diagn Ther. 2019;45(2):76-84. doi: 10.1159/000486853. Epub 2018 Jun 13.

  PMID: 29898442 RESULT

• Nanda S, Savvidou M, Syngelaki A, Akolekar R, Nicolaides KH. Prediction of gestational diabetes mellitus by maternal factors and biomarkers at 11 to 13 weeks. Prenat Diagn. 2011 Feb;31(2):135-41. doi: 10.1002/pd.2636. Epub 2010 Dec 28.

  PMID: 21268030 RESULT

MeSH Terms

Conditions

Diabetes, Gestational

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Gianna Wilkie, MD

  University of Massachusetts Chan Medical School

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gianna L Wilkie, MD

CONTACT

77743642523; Gianna.Wilkie@umassmemorial.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Those assessing the outcomes from the medical chart will be blinded to the randomization process and the assigned study arm. Patients, the primary investigator, and their care providers will be aware of their treatment status.
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This is a prospective, single-center, randomized study evaluating an early screening protocol for identifying women at high risk for developing GDM to the routine standard of care for GDM screening.

Study Record Dates

• First Submitted: May 18, 2022
• First Posted: May 24, 2022
• Study Start: August 18, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: August 26, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)