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Intrapartum Glycemic Control With Insulin Infusion Versus Rotating Fluids

NCT03912363 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 114

Last updated 2025-06-12

No results posted yet for this study

Summary

This study will determine whether rotating intravenous (IV) fluid is better than receiving insulin to control a baby's blood sugar after delivery in laboring women with diabetes. A computer will choose the method of controlling the participant's blood sugar while they are in labor.

Conditions

  • Type II Diabetes Mellitus
  • Gestational Diabetes Mellitus

Interventions

OTHER

Rotating fluids protocol

IV fluids at a rate of 100-150 ml/hr will be administered: * For blood glucose \< 100 mg/dL or less: IV fluids with 5% dextrose * For blood glucose between 101-140 mg/dL: IV fluids without 5% dextrose * For blood glucose \> 140 mg/dL on two consecutive occasions: insulin infusion protocol (Study arm 2)

OTHER

Insulin infusion protocol

Regular insulin at 1 unit/ml AND IV fluids at a rate of 100-150 ml/hr will be administered: * For blood glucose \< 80 mg/dL: No insulin AND IV fluids with 5% dextrose * For blood glucose 80-100 mg/dL: Insulin at 0.5 U/hr AND IV fluids with 5% dextrose * For blood glucose 101-140 mg/dL: Insulin at 1.0 U/hr AND IV fluids with 5% dextrose * For blood glucose 141-180 mg/dL: Insulin at 1.5 U/hr AND IV fluids with 5% dextrose * For blood glucose 181-220 mg/dL: Insulin at 2.0 U/hr AND IV fluid without dextrose * For blood glucose \> 220 mg/dL: Insulin at 2.5 U/hr AND IV fluids without dextrose

Sponsors & Collaborators

  • Geisinger Clinic

    lead OTHER

Principal Investigators

  • Michael J Paglia, MD, PhD · Geisinger Clinic

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
14 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-11-01
Primary Completion
2024-05-30
Completion
2025-03-01

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03912363 on ClinicalTrials.gov