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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Repeat glucose tolerance test (GTT) with continuous glucose monitor | Experimental | 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. |
|
| Control group | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glucose tolerance test and continuous glucose monitor | Diagnostic Test |
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| Measure | Description | Time Frame |
|---|---|---|
| Rate of cesarean delivery | From enrollment until delivery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rebecca Bradley, DO | Contact | 973-862-5262 | rlb310@njms.rutgers.edu | |
| Shauna Williams, MD | Contact | 973-972-5262 | williash@njms.rutgers.edu |
| Name | Affiliation | Role |
|---|---|---|
| Shauna Williams, MD | Rutgers Health New Jersey Medical School | Principal Investigator |
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Deidentified data can be made available upon request.
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| ID | Term |
|---|---|
| D005951 | Glucose Tolerance Test |
| ID | Term |
|---|---|
| D001774 | Blood Chemical Analysis |
| D019963 | Clinical Chemistry Tests |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
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| D003933 | Diagnosis |
| D003940 | Diagnostic Techniques, Endocrine |
| D008919 | Investigative Techniques |