Intrapartum Glucose Management Among Women With Gestational Diabetes Mellitus
- Conditions
- Gestational Diabetes Mellitus
- Interventions
- Other: Standard Protocol for intrapartum glucose managementOther: Experimental Protocol for intrapartum glucose management
- Registration Number
- NCT02596932
- Lead Sponsor
- Women and Infants Hospital of Rhode Island
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 76
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Tight control Standard Protocol for intrapartum glucose management 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 Less tight control Experimental Protocol for intrapartum glucose management 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
- Primary Outcome Measures
Name Time Method Mean neonatal blood glucose levels 24 hours
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Women & Infants Hospital Rhode Island
🇺🇸Providence, Rhode Island, United States