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Intrapartum Glycemic Control With Insulin Infusion Versus Rotating Fluids

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ClinicalTrials.gov Identifier: NCT03912363
Recruitment Status : Recruiting
First Posted : April 11, 2019
Last Update Posted : November 4, 2019
Sponsor:
Information provided by (Responsible Party):
Geisinger Clinic

Tracking Information
First Submitted Date  ICMJE April 9, 2019
First Posted Date  ICMJE April 11, 2019
Last Update Posted Date November 4, 2019
Actual Study Start Date  ICMJE November 1, 2019
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 10, 2019)
Neonatal blood glucose value [ Time Frame: Within 2 hours of life ]
Neonatal blood glucose value from birth to 2 hours of life
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03912363 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 10, 2019)
  • Mean neonatal blood glucose value [ Time Frame: First 24 hours of life ]
    Average of neonatal blood glucose values from birth to 24 hours of life
  • Incidence of maternal hypoglycemia [ Time Frame: During labor (average time 24 hours) ]
    Blood glucose value < 50 mg/dL without symptoms OR Blood glucose value < 70 mg/dL with symptoms such as perspiration, palpitations, tremor, weakness, anxiety
  • Mean intrapartum maternal blood glucose value [ Time Frame: During labor (average time 24 hours) ]
    Average of maternal blood glucose values during labor
  • Maternal blood glucose value before delivery [ Time Frame: Within one hour of delivery ]
    Blood glucose value
  • Incidence of composite neonatal outcome [ Time Frame: First 24 hours of life until discharge (average time 21 days) ]
    Neonatal hypoglycemia, NICU admission, neonatal hyperbilirubinemia, and neonatal respiratory distress syndrome
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Intrapartum Glycemic Control With Insulin Infusion Versus Rotating Fluids
Official Title  ICMJE Intrapartum Glycemic Control With Insulin Infusion Versus Rotating Fluids: Randomized Controlled Trial (RCT)
Brief 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.
Detailed Description

Diabetes complicates 6-9% of all pregnancies. Of those pregnancies, 90% of pregnant diabetics have gestational diabetes mellitus (GDM), while the remainder of patients have pre-existing diabetes mellitus (DM). Maternal hyperglycemia has a negative impact on maternal and fetal/neonatal health. Adverse neonatal outcomes include birth injuries, respiratory distress, and metabolic derangements such as hypoglycemia. The incidence of neonatal hypoglycemia is higher in pregnancies complicated by pre-existing DM (24-48%) when compared to patients with GDM (16-19%).

Neonatal hypoglycemia causes immediate and long-term morbidity. Treatment of hypoglycemia may require admission to the Neonatal Intensive Care Unit (NICU). The severity and duration of neonatal hypoglycemia raises concern for permanent neurologic damage to the neonate. Even transient episodes of neonatal hypoglycemia have been associated with neurodevelopmental impairment. It is imperative that measures be taken in diabetic mothers (both pre-existing and gestational) to minimize the risk of neonatal hypoglycemia. While antepartum maternal glucose control remains an important factor in preventing neonatal complications, prevention of maternal hyperglycemia during the intrapartum period has been shown to reduce the risk of neonatal hypoglycemia.

Therapies utilized for maternal intrapartum glycemic control across academic centers in the United States include the use of insulin and rotation of intravenous (IV) fluids. Although used in clinical practice for intrapartum glycemic control, the impact of rotating IV fluids on neonatal blood glucose is unknown. The potential for using rotating IV fluids to control intrapartum blood glucose has several advantages over using insulin for optimization of blood glucose. There is minimal risk of maternal hypoglycemia using IV fluids when compared to insulin therapy. There is also less risk of medication error. IV fluids are easily administered as they do not require separate peripheral access and are easily accessible on a Labor and Delivery (L&D) unit.

The investigators propose a randomized controlled trial (RCT) to assess the effect of maternal intrapartum glycemic control with rotating IV fluids compared to insulin infusion on neonatal blood glucose levels within two hours of birth. The investigators hypothesize neonates born to mothers managed by rotating fluids will have higher neonatal blood glucose levels (closer to normal range) within two hours of birth compared to neonates born to mothers managed by insulin infusion.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Randomized controlled trial
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Type II Diabetes Mellitus
  • Gestational Diabetes Mellitus
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Active Comparator: Rotating fluids
    Rotating fluids protocol will be initiated at the time of admission to Labor and Delivery.
    Intervention: Other: Rotating fluids protocol
  • Active Comparator: Insulin infusion
    Insulin infusion protocol will be initiated at the time of admission to Labor and Delivery.
    Intervention: Other: Insulin infusion protocol
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 10, 2019)
74
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 30, 2021
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Pregnant women with Type II diabetes mellitus or GDM controlled with insulin and/or hypoglycemic medication (GDMA2)
  • Singleton pregnancies
  • Gestational age between 37 0/7 weeks and 40 0/7 weeks
  • Planned delivery at a Geisinger Medical Center (GMC) or Geisinger Wyoming Valley (GWV)
  • English or Spanish speaking
  • Anticipated delivery at ≥ 4 hours from randomization (e.g., cervical dilation at ≤ 7 cm at time of randomization)

Exclusion Criteria:

  • Women with Type 1 diabetes mellitus or use of insulin pump
  • Evidence of diabetic ketoacidosis at time of admission for delivery
  • Multifetal gestation
  • Gestational age < 37 0/7 weeks or > 40 0/7 weeks
  • Non-English or Non-Spanish speaking
  • Anticipated delivery < 4 hours from randomization (e.g., cervical dilation > 7 cm at time of randomization, first cesarean delivery of the day)
  • Oral corticosteroid use within 48 hours of planned delivery
  • Antenatal corticosteroid use within 7 days of admission for delivery
  • Delivery planned outside of GMC or GWV
  • Fetal demise
  • Prenatal diagnosis of lethal fetal anomaly
  • Active infection or immunocompromised state (e.g., HIV/AIDS, active malignancy, use of immunosuppressant medication) at time of admission for delivery
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 14 Years to 50 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Michael J Paglia, MD, PhD 570-714-1099 mjpaglia@geisinger.edu
Contact: Kajal Angras, DO 570-271-8160 kangras@geisinger.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03912363
Other Study ID Numbers  ICMJE 2018-0502
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Geisinger Clinic
Study Sponsor  ICMJE Geisinger Clinic
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Michael J Paglia, MD, PhD Geisinger Clinic
PRS Account Geisinger Clinic
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP