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.
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SCREENING
Masking
SINGLE
Enrollment
116
Early testing with the 2 hour glucose tolerance test will occur during their inpatient postpartum hospitalization.
Subjects randomized to the comparison condition will receive the usual standard of care. The standard of care will consist of administration of educational materials adapted from the American Diabetes Association that discusses healthy lifestyle behaviors and the increased risks of developing T2DM after a pregnancy complicated by GDM.
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, United States
RECRUITINGDetection of Type 2 Diabetes Mellitus
Detection of Type 2 Diabetes Mellitus by 2 hour oral glucose tolerance test
Time frame: At time of postpartum screening (postpartum day 1 or 6 week postpartum visit pending randomization arm)
Glycemic Outcomes--Hemoglobin A1c
Serum blood measurement of hemoglobin A1c
Time frame: at time of postpartum screening (postpartum day 1 or 6 week postpartum visit pending randomization arm)
Patient Satisfaction
Participant satisfaction will be assessed using the validated survey, the Patient Satisfaction Survey. The survey was developed in 1979 and has been used to assess patient satisfaction with research participation based on 8 simple questions. It has not been used in a randomized trial in an obstetric population but has been validated in other clinical populations
Time frame: At postpartum visit (6 weeks after delivery)
Patient Recruitment
The investigators will examine the total number of subjects that were approached and the reasons for ineligibility and non-participation.
Time frame: at time of randomization (postpartum day 1)
Patient Retention
The investigators will record reasons for failure to complete in hospital diabetes screening and treatment.
Time frame: At postpartum visit (6 weeks after delivery)
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