Large for Gestational Age (LGA), Pregnancy
Conditions
Keywords
Large for gestational age, Ultrasound, Pregnancy
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.
Detailed description
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.
Interventions
DIAGNOSTIC_TESTGlucose tolerance test and continuous glucose monitor
1. Glucose tolerance test 2. Continuous glucose monitoring for two weeks 3. Nutrition counseling
Sponsors
Shauna F. Williams, MD
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of cesarean delivery | From enrollment until delivery |
Contacts
CONTACTRebecca Bradley, DO
CONTACTShauna Williams, MD
PRINCIPAL_INVESTIGATORShauna Williams, MD
Rutgers Health New Jersey Medical School
Outcome results
None listed