Intrapartum Glucose Management Among Women With Gestational Diabetes Mellitus
Primary Purpose
Gestational Diabetes Mellitus
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Standard Protocol for intrapartum glucose management
Experimental Protocol for intrapartum glucose management
Sponsored by
About this trial
This is an interventional other trial for Gestational Diabetes Mellitus focused on measuring Intrapartum
Eligibility Criteria
Inclusion Criteria:
- English or Spanish speaking women with a diagnosis of GDM managed at the Diabetes in Pregnancy Program at Women & Infants Hospital, with a plan to deliver at Women & Infants Hospital
Exclusion Criteria:
- Pre-existing DM, multiple gestations, major fetal anomalies anticipated to require NICU admission, planned cesarean delivery, medications known to effect glucose metabolism other than insulin (i.e. metformin)
Sites / Locations
- Women & Infants Hospital Rhode Island
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Experimental
Arm Label
Tight control
Less tight control
Arm Description
Intervention Standard Care: Tight glucose control protocol: Goal maternal blood glucose 70-100, q 1 hour blood glucose checks, insulin treatment started with single maternal blood glucose level > 100mg/dL or < 60 mg/dL
Intervention: Less Tight glucose control protocol: Goal maternal blood glucose 70-120, q 4 hour blood glucose checks (unless symptomatic), insulin treatment started with single maternal blood glucose > 120 mg/dL or < 60mg/dL
Outcomes
Primary Outcome Measures
Mean neonatal blood glucose levels
Secondary Outcome Measures
Neonatal Intensive Care Unit (NICU) admission
Any admission to Neonatal Intensive Care Unit from moment of birth of neonate until time of discharge of neonate to home
Hours in Neonatal Intensive Care Unit (NICU)
Any time spent in Neonatal Intensive Care Unit from moment of birth of neonate until time of discharge of neonate to home
Maternal hypoglycemia
Full Information
NCT ID
NCT02596932
First Posted
October 31, 2015
Last Updated
January 3, 2019
Sponsor
Women and Infants Hospital of Rhode Island
1. Study Identification
Unique Protocol Identification Number
NCT02596932
Brief Title
Intrapartum Glucose Management Among Women With Gestational Diabetes Mellitus
Official Title
Intrapartum Glucose Management Among Women With Gestational Diabetes Mellitus and Its Impact on Neonatal Blood Glucose Levels
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
February 2016 (undefined)
Primary Completion Date
December 2018 (Actual)
Study Completion Date
December 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Women and Infants Hospital of Rhode Island
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Gestational Diabetes Mellitus (GDM) is one of the most common medical complications of pregnancy. Neonatal hypoglycemia is a common and well described complication for infants born to mothers with GDM and diabetes mellitus (DM) and studies have linked intrapartum maternal glucose levels with neonatal hypoglycemia. While guidelines exist to guide practitioners in how to best manage intrapartum maternal glucose levels among Type I and and Type II DM, there is a paucity of data guiding practitioners in the intrapartum management of blood glucose levels for women with GDM, particularly those treated with insulin antepartum. The goal of this project is to compare two protocols of intrapartum glucose management in women with GDM and investigate the impact on neonatal blood glucose levels.
Detailed Description
Research objective- To compare "Tight" vs. "Less Tight" intrapartum glucose management
Hypothesis: Neonates born to mothers managed via the "Less Tight" intrapartum glucose management protocol will have lower mean glucose levels in the first 24 hours of life when compared to mean glucose levels among infants born to mothers managed via the "Tight" intrapartum glucose management protocol.
Study Design: Randomized trial
Population: English or Spanish speaking women with a diagnosis of GDM managed at the Diabetes in Pregnancy Program at Women & Infants Hospital, with a plan to deliver at Women & Infants Hospital
Once enrolled, patients will then be randomized to "Tight" or "Less Tight" intrapartum glucose control.
Once admitted to the labor floor for intrapartum management the appropriate power plan for glucose control will be initiated. The specifics of labor management will be left to the discretion of the provider.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gestational Diabetes Mellitus
Keywords
Intrapartum
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
76 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tight control
Arm Type
Other
Arm Description
Intervention Standard Care:
Tight glucose control protocol: Goal maternal blood glucose 70-100, q 1 hour blood glucose checks, insulin treatment started with single maternal blood glucose level > 100mg/dL or < 60 mg/dL
Arm Title
Less tight control
Arm Type
Experimental
Arm Description
Intervention:
Less Tight glucose control protocol: Goal maternal blood glucose 70-120, q 4 hour blood glucose checks (unless symptomatic), insulin treatment started with single maternal blood glucose > 120 mg/dL or < 60mg/dL
Intervention Type
Other
Intervention Name(s)
Standard Protocol for intrapartum glucose management
Other Intervention Name(s)
Tight Control
Intervention Description
Tight glucose control protocol: Goal maternal blood glucose 70-100, q 1 hour blood glucose checks, insulin treatment started with single maternal blood glucose level > 100mg/dL or < 60mg/dL
Intervention Type
Other
Intervention Name(s)
Experimental Protocol for intrapartum glucose management
Other Intervention Name(s)
Less Tight Control
Intervention Description
Less Tight: Goal maternal blood glucose 70-120, q 4 hour blood glucose checks (unless symptomatic), insulin treatment started with single maternal blood glucose > 120 mg/dL or < 60 mg/dL
Primary Outcome Measure Information:
Title
Mean neonatal blood glucose levels
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Neonatal Intensive Care Unit (NICU) admission
Description
Any admission to Neonatal Intensive Care Unit from moment of birth of neonate until time of discharge of neonate to home
Time Frame
Birth of neonate until time of discharge of neonate to home up to 7 days
Title
Hours in Neonatal Intensive Care Unit (NICU)
Description
Any time spent in Neonatal Intensive Care Unit from moment of birth of neonate until time of discharge of neonate to home
Time Frame
Birth of neonate until time of discharge of neonate to home up to 7 days
Title
Maternal hypoglycemia
Time Frame
Intrapartum period
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
English or Spanish speaking women with a diagnosis of GDM managed at the Diabetes in Pregnancy Program at Women & Infants Hospital, with a plan to deliver at Women & Infants Hospital
Exclusion Criteria:
Pre-existing DM, multiple gestations, major fetal anomalies anticipated to require NICU admission, planned cesarean delivery, medications known to effect glucose metabolism other than insulin (i.e. metformin)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maureen S Hamel, MD
Organizational Affiliation
Maternal Fetal Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Women & Infants Hospital Rhode Island
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02905
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
31135731
Citation
Hamel MS, Kanno LM, Has P, Beninati MJ, Rouse DJ, Werner EF. Intrapartum Glucose Management in Women With Gestational Diabetes Mellitus: A Randomized Controlled Trial. Obstet Gynecol. 2019 Jun;133(6):1171-1177. doi: 10.1097/AOG.0000000000003257.
Results Reference
derived
Learn more about this trial
Intrapartum Glucose Management Among Women With Gestational Diabetes Mellitus
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