Ignite Creation Date:
2024-05-06 @ 3:34 PM
Last Modification Date:
2024-10-26 @ 1:52 PM
Study NCT ID:
NCT04672031
Status:
RECRUITING
Last Update Posted:
2023-05-11
First Post:
2020-12-08
Brief Title:
Glycemic Targets for Pregnant Women With GDM and T2DM
Sponsor:
University of Southern California
Organization:
University of Southern California
Study Overview
Official Title:
Tight Versus Standard Glycemic Targets for Pregnant Women With Gestational Diabetes and Type 2 Diabetes
Status:
RECRUITING
Status Verified Date:
2023-05
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 purpose of this randomized clinical trial is to determine whether glycemic targets that are lower than those currently recommended by the American Diabetes Association ADA and the American College of Obstetricians and Gynecologists ACOG would improve overall outcomes in pregnant patients with diabetes Eligible pregnant women with a diagnosis of gestational diabetes or Type 2 diabetes will be randomized into either routine care with glycemic targets as currently recommended by ADA and ACOG control arm or more aggressive care with lower glycemic targets that more closely resemble normoglycemia in pregnancy intervention arm The glycemic targets for the control arm will be defined as follows fasting 95 mgdL pre-prandial 95 mgdL and 1-hour postprandial 140 mgdL The glycemic targets for the intervention arm will be defined as follows fasting 80 mgdL pre-prandial 80 mgdL and 1-hour postprandial 110 mgdL The primary outcome will be a 250-gram difference in birth weight between the two study arms Secondary maternal and neonatal outcomes of interest will also be compared between the two study arms
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None