NCT02596932

Intrapartum Glucose Management Among Women With Gestational Diabetes Mellitus

Intrapartum Glucose Management Among Women With Gestational Diabetes Mellitus and Its Impact on Neonatal Blood Glucose Levels

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 76 (actual)
• Sponsor: Women and Infants Hospital of Rhode Island · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Gestational Diabetes Mellitus

Interventions

Type	Name	Description
OTHER	Standard 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
OTHER	Experimental 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

Timeline

• Start date: 2016-02-01
• Primary completion: 2018-12-01
• Completion: 2018-12-01
• First posted: 2015-11-04
• Last updated: 2019-01-07

Locations

1 site across 1 country: United States