Intrapartum Glucose Control and Risk of Neonatal Hypoglycemia

December 8, 2025 updated by: Praveen Ramesh, University of Pittsburgh

Intrapartum Maternal Glucose Control and Effect on 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

218

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • Recruiting
        • Magee-Women's Hospital of UPMC
        • Contact:
        • Contact:
        • Principal Investigator:
          • Praveen Ramesh, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard Intrapartum Glucose Target Range
The goal intrapartum glucose target range will be 70-110mg/dl. Insulin infusion will be initiated when maternal capillary glucose exceeds 110 mg/dL.
Other: Standard Intrapartum Glucose Target Range
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.
Experimental: Liberalized Intrapartum Glucose Target Range
The goal intrapartum glucose target range will be 70-160mg/dl. Insulin infusion will be initiated when maternal capillary glucose exceeds 160 mg/dL.
Other: Liberalized Intrapartum Glucose Target Range
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Within the first 24 hours after delivery.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Prior to neonatal discharge, up to 42 days after delivery.
Mean neonatal blood glucose
Time Frame: Prior to neonatal discharge, up to 42 days after delivery.
Measured in mg/dL
Prior to neonatal discharge, up to 42 days after delivery.
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
Prior to neonatal discharge, up to 42 days after delivery.
NICU admission
Time Frame: Prior to discharge, up to 42 days after delivery.
Number of NICU admission for any indication.
Prior to discharge, up to 42 days after delivery.
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
During labor( for up to 200 hours)
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
During labor( for up to 200 hours)
Mean maternal intrapartum blood glucose
Time Frame: During labor( for up to 200 hours)
Overall mean maternal glucose values in mg/dl
During labor( for up to 200 hours)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pittsburgh

Investigators

  • Principal Investigator: Praveen Ramesh, M.D., University of Pittsburgh

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 3, 2024

Primary Completion (Estimated)

May 1, 2026

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

October 12, 2024

First Submitted That Met QC Criteria

October 14, 2024

First Posted (Actual)

October 16, 2024

Study Record Updates

Last Update Posted (Actual)

December 15, 2025

Last Update Submitted That Met QC Criteria

December 8, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY24050197

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is currently no plan to make individual participant data available to other researchers. The findings are anticipated to be reported in standard specialty journals.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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