Repeat Late GDM Testing and Cesarean Delivery Rates
- Sponsor
- Shauna F. Williams, MD
- Study ID
- NCT07708129
- Status
- Not Yet Recruiting
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Conditions
- Large for Gestational Age (LGA)
- Pregnancy
Eligibility Criteria
- Sex
- FEMALE
- Age
- 18 Years - 50 Years
- Healthy Volunteers
- Accepted
Interventions
- Glucose tolerance test and continuous glucose monitor — DIAGNOSTIC_TEST1. Glucose tolerance test 2. Continuous glucose monitoring for two weeks 3. Nutrition counseling
Study Details
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.
Key Dates
- First listed
- Jul 16, 2026
- Start date
- Aug 1, 2026
- Status verified
- Jul 2026
- Primary completion
- Apr 30, 2028
- Completion
- May 31, 2028
Study Design
- Enrollment
- 144 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- SINGLE_GROUP
- Primary purpose
- DIAGNOSTIC
Arms
- Experimental: Repeat glucose tolerance test (GTT) with continuous glucose monitorGroup 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.
- No Intervention: Control group
Primary Outcome Measure
Rate of cesarean delivery [ Time Frame: From enrollment until delivery ]
Central Contacts
- Rebecca Bradley, DO973-862-5262
- Shauna Williams, MD973-972-5262
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