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NCT Number: NCT06643351

Intrapartum Glucose Control and Risk of Neonatal Hypoglycemia

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.

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Key information

Conditions

Gestational Diabetes Mellitus in Pregnancy Diabetes Mellitus Diabetes, Gestational Endocrine System Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Metabolic Diseases Neonatal Hypoglycemia Nutritional and Metabolic Diseases Pregestational Diabetes Mellitus Pregnancy Complications Urogenital Diseases

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Magee-Women's Hospital of UPMC

Pittsburgh, Pennsylvania, 15213, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standard Intrapartum Glucose Target Range

Other

Intrapartum maternal glucose management involves frequent blood sugar checks and the use of insulin intravenous drip as needed. Maternal capillary blood sugar is checked every 4 hours in early labor, 2 hours in active labor and hourly during the second stage of labor. The frequency of maternal glucose monitoring will not differ by study group. The goal intrapartum glucose target range will be 70-110mg/dl. Insulin infusion will be initiated when maternal capillary glucose exceeds 110 mg/dL. Once an insulin infusion is initiated, glucose monitoring frequency will occur by protocol. A hypoglycemia protocol is initiated if the maternal blood sugar is less than 60mg/dl.

Liberalized Intrapartum Glucose Target Range

Other

Intrapartum maternal glucose management involves frequent blood sugar checks and the use of insulin intravenous drip as needed. Maternal capillary blood sugar is checked every 4 hours in early labor, 2 hours in active labor and hourly during the second stage of labor. The frequency of maternal glucose monitoring will not differ by study group. The goal intrapartum glucose target range will be 70-160mg/dl. Insulin infusion will be initiated when maternal capillary glucose exceeds 160 mg/dL. Once an insulin infusion is initiated, glucose monitoring frequency will occur by protocol. A hypoglycemia protocol is initiated if the maternal blood sugar is less than 60mg/dl.

Primary outcomes

  1. Immediate postnatal Neonatal hypoglycemia

    Time frame: Within the first 24 hours after delivery.

    Number of newborns with neonatal hypoglycemia, defined as a blood glucose of less than 45mg/dL

Secondary outcomes

  1. Any neonatal hypoglycemia

    Time frame: Prior to neonatal discharge, up to 42 days after delivery.

    Number of newborns with neonatal hypoglycemia, defined as a blood glucose of less than 45mg/dL

  2. Mean neonatal blood glucose

    Time frame: Prior to neonatal discharge, up to 42 days after delivery.

    Measured in mg/dL

  3. Neonatal Hypoglycemia Requiring IV Treatment

    Time frame: Prior to neonatal discharge, up to 42 days after delivery.

    number of newborns with hypoglycemia that requires IV treatment

  4. NICU admission

    Time frame: Prior to discharge, up to 42 days after delivery.

    Number of NICU admission for any indication.

  5. Maternal Intrapartum Hyperglycemia

    Time frame: During labor( for up to 200 hours)

    Number of participants that have hyperglycemia episodes. Hyperglycemia is defined as blood sugar levels greater than 180 mg/dl

  6. Maternal intrapartum hypoglycemia

    Time frame: During labor( for up to 200 hours)

    Number of participants that have hypoglycemia episodes. Hyp0glycemia is defined as blood sugar levels less than 60 mg/dl

  7. Mean maternal intrapartum blood glucose

    Time frame: During labor( for up to 200 hours)

    Overall mean maternal glucose values in mg/dl

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Registry information

Official study title

Intrapartum Maternal Glucose Control and Effect on Neonatal Hypoglycemia

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Oct 16, 2024
Registry last updated
Jun 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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