Repeat Late GDM Testing and Cesarean Delivery Rates

NCT07708129 | Not Yet Recruiting

• 1 other identifier: Pro2026000906
• Study Type: interventional
• Target: 144
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Large for Gestational Age (LGA); Pregnancy

Keywords

Large for gestational age; Ultrasound; Pregnancy

Outcome Measures

Primary Outcomes (1)

• Rate of cesarean delivery

  From enrollment until delivery

Study Arms (2)

Repeat glucose tolerance test (GTT) with continuous glucose monitor

EXPERIMENTAL

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

Control group

NO INTERVENTION

Interventions

Glucose tolerance test and continuous glucose monitor DIAGNOSTIC_TEST

1. Glucose tolerance test 2. Continuous glucose monitoring for two weeks 3. Nutrition counseling

Repeat glucose tolerance test (GTT) with continuous glucose monitor

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Shauna F. Williams, MD: lead

MeSH Terms

Interventions

Glucose Tolerance Test

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Investigative Techniques

Study Officials

• Shauna Williams, MD

  Rutgers Health New Jersey Medical School

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rebecca Bradley, DO

CONTACT

973-862-5262; rlb310@njms.rutgers.edu

Shauna Williams, MD

CONTACT

973-972-5262; williash@njms.rutgers.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: July 12, 2026
• First Posted: July 16, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): April 30, 2028
• Study Completion (Estimated): May 31, 2028
• Last Updated: July 16, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share