Intrapartum Glucose Control and Risk of Neonatal Hypoglycemia

University of Pittsburgh

Status: Enrolling

Conditions: Gestational Diabetes Mellitus in Pregnancy; Neonatal Hypoglycemia; Pregestational Diabetes Mellitus

Treatments: Other: Standard Intrapartum Glucose Target Range; Other: Liberalized Intrapartum Glucose Target Range

Study type: Interventional

Funder types: Other

Identifiers

NCT06643351

STUDY24050197

Details and patient eligibility

About

The purpose of this study is to assess whether a liberal intrapartum glycemic target range compared to usual care standard control ranges will lead to a decrease in the rate of neonatal hypoglycemia among pregnant patients in labor with diabetes.

Full description

Neonatal hypoglycemia is a leading cause of admission to the neonatal ICU (NICU) and is associated with increased costs, separation from mothers, and when severe, long term neurological sequelae. Prior research has suggested an association between intrapartum maternal glucose and the risk of neonatal hypoglycemia, so current insulin administration protocols aimed to maintain the blood glucose close to 100mg/dl.

However, recent studies have found inconsistent evidence of a relationship between intrapartum maternal glucose and neonatal hypoglycemia, Furthermore, on review of previously established protocols, improved maternal glucose control came with an increased frequency of neonatal hypoglycemia. Thus, these findings have suggested that relaxing the intrapartum goals for maternal glucose may be associated with improved neonatal outcomes.

Few randomized controlled trials (RCTs) exist in evaluating neonatal outcomes comparing liberal versus tight intrapartum glycemic control. Recent RCTs have found that tight maternal glucose control in labor was associated with lower mean neonatal blood glucose levels in the first 24 hours of life. While another recent RCT found that a permissive blood glucose (up to 180mg/dl) threshold was associated with equivalent neonatal blood glucose levels when compared to the standard, strict thresholds (up to 110mg/dl).

In this study, participants will be recruited at delivery planning outpatient visits or at admission to labor and delivery and stratified by type of diabetes into two groups, either Type 1 Diabetes or Gestational Diabetes(GDM)/Type 2 diabetes. They will then be randomized to one of two intervention groups. The liberalized treatment group will have a target Glucose Range 70 - 160mg/dl and receive treatment via insulin drip will be initiated if the blood sugar exceeds the upper bound. The standard treatment Group will have a glucose target Glucose Range 70 - 110mg/dl and receive treatment via insulin drip will be initiated if the blood sugar exceeds the upper bound.

The specific aim of this project is to determine the effectiveness of liberalized intrapartum glycemic targets in reducing the incidence of neonatal hypoglycemia.

Enrollment: 218 estimated patients

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion criteria

• Pregnant patients with Pre-gestational (Type 1 or Type 2) or Gestational Diabetes
• Singleton Gestations
• Greater than or equal to 35 weeks gestation
• Planned for vaginal delivery at the University of Pittsburgh Medical Center Magee-Womens Hospital (UPMC MWH)

Exclusion criteria

• Major fetal anomalies anticipated to require NICU admission
• Planned Cesarean delivery

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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218 participants in 2 patient groups

Standard Intrapartum Glucose Target Range

Active Comparator group

Description:

The goal intrapartum glucose target range will be 70-110mg/dl. Insulin infusion will be initiated when maternal capillary glucose exceeds 110 mg/dL.

Treatment:

Other: Standard Intrapartum Glucose Target Range

Liberalized Intrapartum Glucose Target Range

Experimental group

Description:

The goal intrapartum glucose target range will be 70-160mg/dl. Insulin infusion will be initiated when maternal capillary glucose exceeds 160 mg/dL.

Treatment:

Other: Liberalized Intrapartum Glucose Target Range