Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06643351
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-12
Brief Title:
Intrapartum Glucose Control and Risk of Neonatal Hypoglycemia
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Intrapartum Maternal Glucose Control and Effect on Neonatal Hypoglycemia
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to assess whether a liberal intrapartum glycemic target range compared to usual care standard control ranges will lead to a decrease in the rate of neonatal hypoglycemia among pregnant patients in labor with diabetes
Detailed Description:
Neonatal hypoglycemia is a leading cause of admission to the neonatal ICU NICU and is associated with increased costs separation from mothers and when severe long term neurological sequelae Prior research has suggested an association between intrapartum maternal glucose and the risk of neonatal hypoglycemia so current insulin administration protocols aimed to maintain the blood glucose close to 100mgdl
However recent studies have found inconsistent evidence of a relationship between intrapartum maternal glucose and neonatal hypoglycemia Furthermore on review of previously established protocols improved maternal glucose control came with an increased frequency of neonatal hypoglycemia Thus these findings have suggested that relaxing the intrapartum goals for maternal glucose may be associated with improved neonatal outcomes
Few randomized controlled trials RCTs exist in evaluating neonatal outcomes comparing liberal versus tight intrapartum glycemic control Recent RCTs have found that tight maternal glucose control in labor was associated with lower mean neonatal blood glucose levels in the first 24 hours of life While another recent RCT found that a permissive blood glucose up to 180mgdl threshold was associated with equivalent neonatal blood glucose levels when compared to the standard strict thresholds up to 110mgdl
In this study participants will be recruited at delivery planning outpatient visits or at admission to labor and delivery and stratified by type of diabetes into two groups either Type 1 Diabetes or Gestational DiabetesGDMType 2 diabetes They will then be randomized to one of two intervention groups The liberalized treatment group will have a target Glucose Range 70 - 160mgdl and receive treatment via insulin drip will be initiated if the blood sugar exceeds the upper bound The standard treatment Group will have a glucose target Glucose Range 70 - 110mgdl and receive treatment via insulin drip will be initiated if the blood sugar exceeds the upper bound
The specific aim of this project is to determine the effectiveness of liberalized intrapartum glycemic targets in reducing the incidence of neonatal hypoglycemia
However recent studies have found inconsistent evidence of a relationship between intrapartum maternal glucose and neonatal hypoglycemia Furthermore on review of previously established protocols improved maternal glucose control came with an increased frequency of neonatal hypoglycemia Thus these findings have suggested that relaxing the intrapartum goals for maternal glucose may be associated with improved neonatal outcomes
Few randomized controlled trials RCTs exist in evaluating neonatal outcomes comparing liberal versus tight intrapartum glycemic control Recent RCTs have found that tight maternal glucose control in labor was associated with lower mean neonatal blood glucose levels in the first 24 hours of life While another recent RCT found that a permissive blood glucose up to 180mgdl threshold was associated with equivalent neonatal blood glucose levels when compared to the standard strict thresholds up to 110mgdl
In this study participants will be recruited at delivery planning outpatient visits or at admission to labor and delivery and stratified by type of diabetes into two groups either Type 1 Diabetes or Gestational DiabetesGDMType 2 diabetes They will then be randomized to one of two intervention groups The liberalized treatment group will have a target Glucose Range 70 - 160mgdl and receive treatment via insulin drip will be initiated if the blood sugar exceeds the upper bound The standard treatment Group will have a glucose target Glucose Range 70 - 110mgdl and receive treatment via insulin drip will be initiated if the blood sugar exceeds the upper bound
The specific aim of this project is to determine the effectiveness of liberalized intrapartum glycemic targets in reducing the incidence of neonatal hypoglycemia
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None