Repeat Late GDM Testing and Cesarean Delivery Rates

Impact of Late Gestational Diabetes Detection and Treatment on Cesarean Delivery Rates After Negative Initial Screening

The goal of this randomized trial is determine if re-testing for gestational diabetes in the third trimester after an ultrasound measurement of estimated fetal weight (EFW) or abdominal circumference greater than 90%ile decreases cesarean delivery rate, and to evaluate the optimal method of re-testing. The main question it aims to answer is:

Does repeat testing for gestational diabetes and management of hyperglycemia decrease the cesarean delivery rate in fetuses measuring >90%ile by estimated fetal weight (EFW) or abdominal circumference (AC) on ultrasound in the third trimester.

Participants will be randomized into two groups: Group 1 will undergo a repeat glucose tolerance test (GTT) with blinded continuous glucose monitor (CGM) and group 2 will have no intervention. Participants in group 1 will receive nutrition counseling as this would be standard in patients at high risk for gestational diabetes.

Study Overview

• Status: Not yet recruiting
• Conditions: Pregnancy; Large for Gestational Age (LGA)
• Intervention / Treatment: Diagnostic test: Glucose tolerance test and continuous glucose monitor

Detailed Description

This will be a prospective randomized control trial to determine if re-testing for gestational diabetes in the third trimester after an ultrasound measurement of estimated fetal weight (EFW) or abdominal circumference greater than 90%ile decreases cesarean delivery rate, and to evaluate the optimal method of re-testing. Pregnant women will be recruited with gestational age between 30 weeks and 36 weeks gestation with an ultrasound that demonstrates a fetus with either estimated fetal weight (EFW) >90%, abdominal circumference (AC)>90% or both. They will be randomized into two groups: Group 1 will undergo a repeat glucose tolerance test (GTT) with blinded continuous glucose monitor (CGM) and group 2 will have no intervention. Participants in group 1 will receive nutrition counseling as this would be standard in patients at high risk for gestational diabetes.

The primary outcome is cesarean delivery. Labor course, complications, and delivery/neonatal data will be obtained.

• Study Type: Interventional
• Enrollment (Estimated): 144
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rebecca Bradley, DO; Phone Number: 973-862-5262; Email: rlb310@njms.rutgers.edu
• Study Contact Backup: Name: Shauna Williams, MD; Phone Number: 973-972-5262; Email: williash@njms.rutgers.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Gestational age 30 weeks 0 days and 36 weeks 6 days
• Ultrasound with estimated fetal weight or abdominal circumference greater than 90th%ile
• Age 18-50 years old.

Exclusion Criteria:

• Previously diagnosed gestational diabetes or pre-gestational diabetes
• Multiple gestation
• Previous cesarean delivery
• Any condition precluding vaginal delivery (placenta previa/placenta accreta spectrum disorders, vasa previa, prior uterine surgery with contraindication to vaginal delivery)
• Suboptimal dating (based on US >22wk gestation)
• Contraindication to glucose tolerance test

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group
Experimental: Repeat glucose tolerance test (GTT) with continuous glucose monitor; Group 1 will undergo a repeat glucose tolerance test (GTT) with blinded continuous glucose monitor (CGM). Patients will receive nutrition counseling as this would be standard in patients at high risk for gestational diabetes. The CGM sensor will collect glycemic data over 10 consecutive days, with up to 20 days of CGM data per patient, ie they will wear two 10-day CGMs in total. The patients in group 1, as well as the researchers and the patient's provider will know the patient is wearing a CGM, however the CGM data will be blinded until the patient delivers.	Diagnostic test: Glucose tolerance test and continuous glucose monitor; Glucose tolerance test; Continuous glucose monitoring for two weeks; Nutrition counseling

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Rate of cesarean delivery	From enrollment until delivery

Collaborators and Investigators

• Sponsor: Shauna F. Williams, MD
• Investigators: Principal Investigator: Shauna Williams, MD, Rutgers Health New Jersey Medical School

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): April 30, 2028
• Study Completion (Estimated): May 31, 2028

Study Registration Dates

• First Submitted: July 12, 2026
• First Submitted That Met QC Criteria: July 12, 2026
• First Posted (Actual): July 16, 2026

Study Record Updates

• Last Update Posted (Actual): July 16, 2026
• Last Update Submitted That Met QC Criteria: July 12, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Ultrasound; Pregnancy; Large for gestational age
• Additional Relevant MeSH Terms: Investigative Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Blood Chemical Analysis; Clinical Chemistry Tests; Diagnostic Techniques, Endocrine; Glucose Tolerance Test
• Other Study ID Numbers: Pro2026000906

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Deidentified data can be made available upon request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No