Status:
COMPLETED
Self-Administered 2-Hour Oral Glucose Tolerance Test
Lead Sponsor:
Prisma Health-Upstate
Conditions:
Gestational Diabetes
Postpartum Disorder
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
The goal of this randomized controlled trial is to evaluate whether self-administered postpartum diabetes screening tests in patients with gestational diabetes improves screening completion rates. The...
Detailed Description
Gestational diabetes affects up to 10% of pregnancies, with increasing prevalence. Due to the risk of developing overt type 2 diabetes mellitus, patients are recommended to complete postpartum diabete...
Eligibility Criteria
Inclusion
- Maternal age 18 years or older
- English or Spanish speaking
- Diagnosis of gestational diabetes with recommendation for postpartum screening, by any of the following criteria (1) HgbA1c 5.9-6.4% at ≤ 14 6/7 weeks, (2) HgbA1c ≥ 5.9% at 15-23 6/7 weeks, (3) 50-gram oral glucose tolerance test plasma glucose value ≥ 200 mg/dL, (4) 2 or more abnormal plasma glucose values on a 100-gram oral glucose tolerance test with the following thresholds: fasting ≥ 95 mg/dL, 1 hour ≥ 180 mg/dL, 2 hour ≥155 mg/dL, 3 hour ≥140 mg/dL or (5) fasting blood glucose ≥ 126
- No personal history of Type 1 or Type 2 diabetes defined by self-reported or documented history, or HgbA1c \>/=6.5% at ≤ 14 6/7 weeks gestation
- Antepartum care with Prisma Health affiliated obstetric practices
- Delivery at Greenville Memorial Hospital
- Active Epic MyChart access at time of enrollment
- Capable of providing informed consent
Exclusion
- Pre-pregnancy diagnosis of diabetes (Type 1, 2, or other form of diabetes)
- No glucometer or supplies for fingerstick glucose monitoring, or inability to perform fingerstick glucose monitoring
- Unable to provide informed consent
- Inability to follow up for routine postpartum care
Key Trial Info
Start Date :
November 2 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2025
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06099509
Start Date
November 2 2023
End Date
May 1 2025
Last Update
July 2 2025
Active Locations (1)
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1
Prisma Health/Greenville Memorial Hospital
Greenville, South Carolina, United States, 29605