Preventing Type 2 Diabetes Mellitus After Gestational Diabetes Mellitus With Immediate Postpartum Screening
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Gestational Diabetes
- Sponsor
- University of Massachusetts, Worcester
- Enrollment
- 116
- Locations
- 1
- Primary Endpoint
- Detection of Type 2 Diabetes Mellitus
- Status
- Recruiting
- Last Updated
- 9 months ago
Overview
Brief Summary
The overall goal of this proposal is to create and test an implementation protocol for in-hospital immediate postpartum diabetes screening for postpartum patients with pregnancies affected by GDM.
Detailed Description
Gestational diabetes mellitus (GDM) affects 6 to 8% of U.S. pregnancies annually and upwards of 1 in every 8 pregnancies worldwide. Pregnant individuals with GDM have higher rates of hypertensive disorders of pregnancy, cesarean delivery, and maternal mortality as compared to those without GDM. While GDM frequently resolves after delivery, up to 70% of patients will develop type 2 diabetes mellitus (T2DM) later in life10 and one third will develop subsequent diabetes or impaired glucose metabolism at the time of postpartum screening. While postpartum screening is recommended by the American College of Obstetricians and Gynecologists (ACOG) and the American Diabetes Association (ADA) between 4-12 weeks postpartum for all patients with GDM in pregnancy, nearly 40% of patients do not attend a postpartum visit. Attendance is even lower among populations with limited resources, contributing to health disparities. To address this issue, immediate in-hospital postpartum glucose tolerance testing has been evaluated and found to yield diagnostic values comparable to postpartum screening with the advantage of \~100% adherence. However, 2 challenges remain: currently there is a lack of widespread clinical implementation of in-hospital immediate postpartum diabetes screening. Therefore, the overall goal of this proposal is to randomize patients to early screening during their postpartum hospitalization versus at their 6 week postpartum visit (current standard of care).
Investigators
Gianna Wilkie
Assistant Professor
University of Massachusetts, Worcester
Eligibility Criteria
Inclusion Criteria
- •pregnancy complicated by GDM as diagnosed with traditional two step testing in the third trimester according to Carpenter-Coustan Criteria
- •receiving prenatal care at UMASS Memorial and plans to deliver at UMASS Memorial
- •able and willing to provide informed consent
- •ability to complete immediate in hospital postpartum glucose testing
- •have evidence of impaired glucose metabolism defined as fasting glucose value of ≥126 mg/dL or 2-hour glucose value of ≥200 mg/dL
Exclusion Criteria
- •known diagnosis of pre-existing pre-gestational diabetes in pregnancy
- •inability to complete oral glucose tolerance test (e.g. gastric bypass surgery history, gastric dumping syndrome history, vomiting of oral glucose tolerance test) in pregnancy or immediately postpartum
- •systemic steroid use
Outcomes
Primary Outcomes
Detection of Type 2 Diabetes Mellitus
Time Frame: At time of postpartum screening (postpartum day 1 or 6 week postpartum visit pending randomization arm)
Detection of Type 2 Diabetes Mellitus by 2 hour oral glucose tolerance test
Glycemic Outcomes--Hemoglobin A1c
Time Frame: at time of postpartum screening (postpartum day 1 or 6 week postpartum visit pending randomization arm)
Serum blood measurement of hemoglobin A1c
Secondary Outcomes
- Patient Satisfaction(At postpartum visit (6 weeks after delivery))
- Patient Recruitment(at time of randomization (postpartum day 1))
- Patient Retention(At postpartum visit (6 weeks after delivery))