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_TEST
    1. 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 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.
  • No Intervention: Control group

Primary Outcome Measure

Rate of cesarean delivery [ Time Frame: From enrollment until delivery ]

Central Contacts

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