Intrapartum Glucose Control and Risk of Neonatal Hypoglycemia

NCT06643351 | Active Not Recruiting

• 1 other identifier: STUDY24050197
• Study Type: interventional
• Target: 169
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

Gestational Diabetes; Pregestational Diabetes; Neonatal Hypoglycemia; Intrapartum Glucose

Outcome Measures

Primary Outcomes (1)

• Immediate postnatal Neonatal hypoglycemia

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

  Within the first 24 hours after delivery.

Secondary Outcomes (7)

• Any neonatal hypoglycemia

  Prior to neonatal discharge, up to 42 days after delivery.

• Mean neonatal blood glucose

  Prior to neonatal discharge, up to 42 days after delivery.

• Neonatal Hypoglycemia Requiring IV Treatment

  Prior to neonatal discharge, up to 42 days after delivery.

• NICU admission

  Prior to discharge, up to 42 days after delivery.

• Maternal Intrapartum Hyperglycemia

  During labor( for up to 200 hours)

Study Arms (2)

Standard Intrapartum Glucose Target Range

ACTIVE COMPARATOR

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

Liberalized Intrapartum Glucose Target Range

EXPERIMENTAL

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

Interventions

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.

Liberalized Intrapartum Glucose Target Range

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.

Standard Intrapartum Glucose Target Range

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (1)

Magee-Women's Hospital of UPMC

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (5)

• Dude AM, Niznik C, Peaceman AM, Yee LM. Evaluation of an Intrapartum Insulin Regimen for Women With Diabetes. Obstet Gynecol. 2020 Aug;136(2):411-416. doi: 10.1097/AOG.0000000000003940.

  PMID: 32649492 BACKGROUND

• Yamamoto JM, Benham J, Mohammad K, Donovan LE, Wood S. Intrapartum glycaemic control and neonatal hypoglycaemia in pregnancies complicated by diabetes: a systematic review. Diabet Med. 2018 Feb;35(2):173-183. doi: 10.1111/dme.13546.

  PMID: 29117445 BACKGROUND

• American College of Obstetricians and Gynecologists' Committee on Practice Bulletins-Obstetrics. ACOG Practice Bulletin No. 201: Pregestational Diabetes Mellitus. Obstet Gynecol. 2018 Dec;132(6):e228-e248. doi: 10.1097/AOG.0000000000002960.

  PMID: 30461693 BACKGROUND

• Dude A, Niznik CM, Szmuilowicz ED, Peaceman AM, Yee LM. Management of Diabetes in the Intrapartum and Postpartum Patient. Am J Perinatol. 2018 Sep;35(11):1119-1126. doi: 10.1055/s-0038-1629903. Epub 2018 Mar 13.

  PMID: 29534258 BACKGROUND

• Burns CM, Rutherford MA, Boardman JP, Cowan FM. Patterns of cerebral injury and neurodevelopmental outcomes after symptomatic neonatal hypoglycemia. Pediatrics. 2008 Jul;122(1):65-74. doi: 10.1542/peds.2007-2822.

  PMID: 18595988 BACKGROUND

MeSH Terms

Conditions

Diabetes, Gestational

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Praveen Ramesh, M.D.

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Fellow Physician, Division of Maternal-Fetal Medicine, Department of Obstetrics, Gynecology, and Reproductive Sciences

Study Record Dates

• First Submitted: October 12, 2024
• First Posted: October 16, 2024
• Study Start: December 3, 2024
• Primary Completion: May 1, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: June 8, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)