Repeat Late GDM Testing and Cesarean Delivery Rates

ConditionsLarge for Gestational Age (LGA)Pregnancy

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexFemale

Age18-50

SponsorShauna F. Williams, MD

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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)

Trial design

Design model

Single group

Treatments tested in this trial

Glucose tolerance test and continuous glucose monitor
Diagnostic test
1. Glucose tolerance test 2. Continuous glucose monitoring for two weeks 3. Nutrition counseling

Treatment groups

144 Participants

are divided into 2 treatment groups

Group A: Repeat glucose tolerance test (GTT) with continuous glucose monitorExperimental treatment 1 intervention

Group B: Control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

Rate of cesarean delivery

Time frame

From enrollment until delivery

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shauna F. Williams, MD

Lead sponsor

Rutgers, The State University of New Jersey

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: