Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Intrapartum Glycemic Control With Insulin Infusion Versus Rotating Fluids

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Type II Diabetes Mellitus Gestational Diabetes Mellitus Other: Rotating fluids protocol Other: Insulin infusion protocol Not Applicable

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 74 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized controlled trial
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Intrapartum Glycemic Control With Insulin Infusion Versus Rotating Fluids: Randomized Controlled Trial (RCT)
Actual Study Start Date : November 1, 2019
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : June 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Sugar

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Active Comparator: Rotating fluids
Rotating fluids protocol will be initiated at the time of admission to Labor and Delivery.
 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)
Active Comparator: Insulin infusion
Insulin infusion protocol will be initiated at the time of admission to Labor and Delivery.
 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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Neonatal blood glucose value [ Time Frame: Within 2 hours of life ]
    Neonatal blood glucose value from birth to 2 hours of life


Secondary Outcome Measures :
  1. 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

  2. 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

  3. Mean intrapartum maternal blood glucose value [ Time Frame: During labor (average time 24 hours) ]
    Average of maternal blood glucose values during labor

  4. Maternal blood glucose value before delivery [ Time Frame: Within one hour of delivery ]
    Blood glucose value

  5. 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


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   14 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03912363


Contacts
Layout table for location contacts
Contact: Michael J Paglia, MD, PhD 570-714-1099 mjpaglia@geisinger.edu
Contact: Kajal Angras, DO 570-271-8160 kangras@geisinger.edu

Locations
Layout table for location information
United States, Pennsylvania
Geisinger Recruiting
Danville, Pennsylvania, United States, 17822
Contact: Michael J Paglia, MD, PhD    570-714-1099    mjpaglia@geisinger.edu   
Contact: Kajal Angras, DO    570-271-8160    kangras@geisinger.edu   
Sub-Investigator: Michael J Paglia, MD, PhD         
Principal Investigator: Kajal Angras, DO         
Geisinger Wyoming Valley Recruiting
Wilkes-Barre, Pennsylvania, United States, 18711
Contact: Michael J Paglia, MD, PhD    570-714-1099    mjpaglia@geisinger.edu   
Contact: Kajal Angras, DO    570-271-8160    kangras@geisinger.edu   
Sub-Investigator: Michael J Paglia, MD, PhD         
Principal Investigator: Kajal Angras, DO         
Sponsors and Collaborators
Geisinger Clinic
Investigators
Layout table for investigator information
Principal Investigator: Michael J Paglia, MD, PhD Geisinger Clinic
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications:

Layout table for additonal information
Responsible Party: Geisinger Clinic
ClinicalTrials.gov Identifier: NCT03912363     History of Changes
Other Study ID Numbers: 2018-0502
First Posted: April 11, 2019    Key Record Dates
Last Update Posted: November 4, 2019
Last Verified: October 2019

Layout table for additional information
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
Keywords provided by Geisinger Clinic:
intrapartum
glycemic control
diabetes
insulin
Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes, Gestational
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Pregnancy Complications
Insulin
Insulin, Globin Zinc
Hypoglycemic Agents
Physiological Effects of Drugs