Intrapartum Glucose Management Among Women With Gestational Diabetes Mellitus

Women and Infants Hospital of Rhode Island

Status: Completed

Conditions: Gestational Diabetes Mellitus

Treatments: Other: Standard Protocol for intrapartum glucose management; Other: Experimental Protocol for intrapartum glucose management

Study type: Interventional

Funder types: Other

Identifiers

NCT02596932

809018

Details and patient eligibility

About

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.

Full 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.

Enrollment: 76 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

76 participants in 2 patient groups

Tight control

Other group

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

Treatment:

Other: Standard Protocol for intrapartum glucose management

Less tight control

Experimental group

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

Treatment:

Other: Experimental Protocol for intrapartum glucose management