An interventional study of Standard Intrapartum Glucose Target Range and Liberalized Intrapartum Glucose Target Range in Gestational Diabetes Mellitus in Pregnancy, Pregestational Diabetes Mellitus and Neonatal Hypoglycemia, sponsored by University of Pittsburgh. Completed at 1 site in United States. Open to female participants. Per ClinicalTrials.gov, last updated 2026-08-14.
Sponsored by University of Pittsburgh · Not applicable, Interventional, and Treatment
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.
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.
842 studies on the registry are indexed under Diabetes, Gestational; 198 are open to participants now.
This study's enrollment of 169 is above the median of 110 across 550 interventional studies indexed under Diabetes, Gestational.
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Of its 8 completed or terminated interventional studies of FDA-regulated products, 4 (50%) have results posted.
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Exclusion Criteria:
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
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 70-110mg/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.
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.
Immediate postnatal Neonatal hypoglycemia
Number of newborns with neonatal hypoglycemia, defined as a blood glucose of less than 45mg/dL
Time frame: Within the first 24 hours after delivery.
Any neonatal hypoglycemia
Number of newborns with neonatal hypoglycemia, defined as a blood glucose of less than 45mg/dL
Time frame: Prior to neonatal discharge, up to 42 days after delivery.
Mean neonatal blood glucose
Measured in mg/dL
Time frame: Prior to neonatal discharge, up to 42 days after delivery.
Neonatal Hypoglycemia Requiring IV Treatment
number of newborns with hypoglycemia that requires IV treatment
Time frame: Prior to neonatal discharge, up to 42 days after delivery.
NICU admission
Number of NICU admission for any indication.
Time frame: Prior to discharge, up to 42 days after delivery.
Maternal Intrapartum Hyperglycemia
Number of participants that have hyperglycemia episodes. Hyperglycemia is defined as blood sugar levels greater than 180 mg/dl
Time frame: During labor( for up to 200 hours)
Maternal intrapartum hypoglycemia
Number of participants that have hypoglycemia episodes. Hyp0glycemia is defined as blood sugar levels less than 60 mg/dl
Time frame: During labor( for up to 200 hours)
Mean maternal intrapartum blood glucose
Overall mean maternal glucose values in mg/dl
Time frame: During labor( for up to 200 hours)
Plan to share: No — 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.
This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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