Gestational Diabetes Mellitus
Conditions
Keywords
Intrapartum
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.
Interventions
OTHERStandard Protocol for intrapartum glucose management
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
OTHERExperimental Protocol for intrapartum glucose management
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
Sponsors
Women and Infants Hospital of Rhode Island
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean neonatal blood glucose levels | 24 hours |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Neonatal Intensive Care Unit (NICU) admission | Birth of neonate until time of discharge of neonate to home up to 7 days | 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) | Birth of neonate until time of discharge of neonate to home up to 7 days | Any time spent in Neonatal Intensive Care Unit from moment of birth of neonate until time of discharge of neonate to home |
| Maternal hypoglycemia | Intrapartum period | — |
Countries
United States
Outcome results
None listed