Preventing Type 2 Diabetes Mellitus After Gestational Diabetes Mellitus With Immediate Postpartum Screening
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 116
- 试验地点
- 3
- 主要终点
- Detection of Type 2 Diabetes Mellitus
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Early Postpartum GDM Screening
Subjects who are randomly assigned to this condition will be screened for GDM with the recommended 2-hour glucose tolerance test during their postpartum hospitalization.
干预措施: Glucose tolerance test (2 hour) (Diagnostic Test)
Standard of Care Postpartum Screening
Subjects randomized to the comparison condition will receive the usual standard of care. The standard of care will consist of screening with a 2 hour glucose tolerance test at 6-12 weeks postpartum.
干预措施: Active Comparator (Other)
结局指标
主要结局
Detection of Type 2 Diabetes Mellitus
时间窗: 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
时间窗: at time of postpartum screening (postpartum day 1 or 6 week postpartum visit pending randomization arm)
Serum blood measurement of hemoglobin A1c
次要结局
- 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))
研究者
Gianna Wilkie
Assistant Professor
University of Massachusetts, Worcester