Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06457139
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-13
First Post:
2024-06-06
Brief Title:
Preventing T2DM After GDM With Immediate Postpartum Screening and Treatment
Sponsor:
University of Massachusetts Worcester
Organization:
University of Massachusetts Worcester
Study Overview
Official Title:
Preventing Type 2 Diabetes Mellitus After Gestational Diabetes Mellitus With Immediate Postpartum Screening and Treatment
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The overall goal of this proposal is to create and test an implementation protocol for in-hospital immediate postpartum diabetes screening and subsequent treatment with metformin for postpartum patients with pregnancies affected by GDM
Detailed Description:
Gestational diabetes mellitus GDM affects 6 to 8 of US 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 1 in-hospital immediate postpartum diabetes screening and 2 treatment with metformin for those patients who screen positive
To implement early in-hospital screening and treatment providers require clear guidelines on the optimal management of patients with impaired glucose tolerance Therefore the overall goal of this proposal is to create and test an implementation protocol for in-hospital immediate postpartum diabetes screening and subsequent treatment for postpartum patients with pregnancies affected by GDM
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 1 in-hospital immediate postpartum diabetes screening and 2 treatment with metformin for those patients who screen positive
To implement early in-hospital screening and treatment providers require clear guidelines on the optimal management of patients with impaired glucose tolerance Therefore the overall goal of this proposal is to create and test an implementation protocol for in-hospital immediate postpartum diabetes screening and subsequent treatment for postpartum patients with pregnancies affected by GDM
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None