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NCT Number: NCT07708129

Repeat Late GDM Testing and Cesarean Delivery Rates

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.

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Key information

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Glucose tolerance test and continuous glucose monitor

Diagnostic Test
  • Glucose tolerance test
  • Continuous glucose monitoring for two weeks
  • Nutrition counseling

Primary outcomes

  1. Rate of cesarean delivery

    Time frame: From enrollment until delivery

Study contacts

Contact information is provided by the study sponsor or research team.

Rebecca Bradley, DO

CONTACT

[email protected]

973-862-5262

Shauna Williams, MD

CONTACT

[email protected]

973-972-5262

Sponsors and collaborators

Lead sponsor

Shauna F. Williams, MD

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jul 16, 2026
Registry last updated
Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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