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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early Postpartum GDM Screening | Experimental | 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. |
|
| Standard of Care Postpartum Screening | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glucose tolerance test (2 hour) | Diagnostic Test | Early testing with the 2 hour glucose tolerance test will occur during their inpatient postpartum hospitalization. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Detection of Type 2 Diabetes Mellitus | Detection of Type 2 Diabetes Mellitus by 2 hour oral glucose tolerance test | 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 | at time of postpartum screening (postpartum day 1 or 6 week postpartum visit pending randomization arm) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | At postpartum visit (6 weeks after delivery) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gianna Wilkie, MD | Contact | 508-3444982 | Gianna.Wilkie@umassmemorial.org |
| Name | Affiliation | Role |
|---|---|---|
| Gianna Wilkie, MD | UMASS Memorial Healthcare | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Massachusetts Memorial Medical Center | Recruiting | Worcester | Massachusetts | 01605 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31351065 | Background | Waters TP, Kim SY, Werner E, Dinglas C, Carter EB, Patel R, Sharma AJ, Catalano P. Should women with gestational diabetes be screened at delivery hospitalization for type 2 diabetes? Am J Obstet Gynecol. 2020 Jan;222(1):73.e1-73.e11. doi: 10.1016/j.ajog.2019.07.035. Epub 2019 Jul 24. | |
| 28910846 | Background |
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| ID | Term |
|---|---|
| D016640 | Diabetes, Gestational |
| D003924 | Diabetes Mellitus, Type 2 |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D044882 | Glucose Metabolism Disorders |
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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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| Active Comparator | Other | 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. |
|
| Patient Recruitment | The investigators will examine the total number of subjects that were approached and the reasons for ineligibility and non-participation. | at time of randomization (postpartum day 1) |
| Patient Retention | The investigators will record reasons for failure to complete in hospital diabetes screening and treatment. | At postpartum visit (6 weeks after delivery) |
| Dinglas C, Muscat J, Heo H, Islam S, Vintzileos A. Immediate Postpartum Glucose Tolerance Testing in Women with Gestational Diabetes: A Pilot Study. Am J Perinatol. 2017 Oct;34(12):1264-1270. doi: 10.1055/s-0037-1606620. Epub 2017 Sep 14. No abstract available. |
| 18826999 | Background | Ratner RE, Christophi CA, Metzger BE, Dabelea D, Bennett PH, Pi-Sunyer X, Fowler S, Kahn SE; Diabetes Prevention Program Research Group. Prevention of diabetes in women with a history of gestational diabetes: effects of metformin and lifestyle interventions. J Clin Endocrinol Metab. 2008 Dec;93(12):4774-9. doi: 10.1210/jc.2008-0772. Epub 2008 Sep 30. |
| 11832527 | Background | Knowler WC, Barrett-Connor E, Fowler SE, Hamman RF, Lachin JM, Walker EA, Nathan DM; Diabetes Prevention Program Research Group. Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. N Engl J Med. 2002 Feb 7;346(6):393-403. doi: 10.1056/NEJMoa012512. |
| 32470456 | Result | Werner EF, Has P, Rouse D, Clark MA. Two-day postpartum compared with 4- to 12-week postpartum glucose tolerance testing for women with gestational diabetes. Am J Obstet Gynecol. 2020 Sep;223(3):439.e1-439.e7. doi: 10.1016/j.ajog.2020.05.036. Epub 2020 May 26. |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D003933 | Diagnosis |
| D003940 | Diagnostic Techniques, Endocrine |
| D008919 | Investigative Techniques |