Intrapartum Glycemic Control With Insulin Infusion Versus Rotating Fluids

Intrapartum Glycemic Control With Insulin Infusion Versus Rotating Fluids: Randomized Controlled Trial (RCT)

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.

Study Overview

• Status: Recruiting
• Conditions: Type II Diabetes Mellitus; Gestational Diabetes Mellitus
• Intervention / Treatment: Other: Rotating fluids protocol; Other: Insulin infusion protocol

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: Interventional
• Enrollment (Estimated): 74
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Michael J Paglia, MD, PhD; Phone Number: 570-714-1099; Email: mjpaglia@geisinger.edu
• Study Contact Backup: Name: Kajal Angras, DO; Phone Number: 570-271-8160; Email: kangras@geisinger.edu

Study Locations

• United States
  • Pennsylvania
    • Danville, Pennsylvania, United States, 17822
      • Recruiting
      • Geisinger
      • Contact: Michael J Paglia, MD, PhD; Phone Number: 570-714-1099; Email: mjpaglia@geisinger.edu
      • Contact: Kajal Angras, DO; Phone Number: 570-271-8160; Email: kangras@geisinger.edu
      • Sub-Investigator: Michael J Paglia, MD, PhD
      • Principal Investigator: Kajal Angras, DO
    • Wilkes-Barre, Pennsylvania, United States, 18711
      • Recruiting
      • Geisinger Wyoming Valley
      • Contact: Michael J Paglia, MD, PhD; Phone Number: 570-714-1099; Email: mjpaglia@geisinger.edu
      • Contact: Kajal Angras, DO; Phone Number: 570-271-8160; Email: kangras@geisinger.edu
      • Sub-Investigator: Michael J Paglia, MD, PhD
      • Principal Investigator: Kajal Angras, DO

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 50 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neonatal blood glucose value	Neonatal blood glucose value from birth to 2 hours of life	Within 2 hours of life

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean neonatal blood glucose value	Average of neonatal blood glucose values from birth to 24 hours of life	First 24 hours of life
Incidence of maternal hypoglycemia	Blood glucose value < 50 mg/dL without symptoms OR Blood glucose value < 70 mg/dL with symptoms such as perspiration, palpitations, tremor, weakness, anxiety	During labor (average time 24 hours)
Mean intrapartum maternal blood glucose value	Average of maternal blood glucose values during labor	During labor (average time 24 hours)
Maternal blood glucose value before delivery	Blood glucose value	Within one hour of delivery
Incidence of composite neonatal outcome	Neonatal hypoglycemia, NICU admission, neonatal hyperbilirubinemia, and neonatal respiratory distress syndrome	First 24 hours of life until discharge (average time 21 days)

Collaborators and Investigators

• Sponsor: Geisinger Clinic
• Investigators: Principal Investigator: Michael J Paglia, MD, PhD, Geisinger Clinic

Publications and helpful links

General Publications

• 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.
• DeSisto CL, Kim SY, Sharma AJ. Prevalence estimates of gestational diabetes mellitus in the United States, Pregnancy Risk Assessment Monitoring System (PRAMS), 2007-2010. Prev Chronic Dis. 2014 Jun 19;11:E104. doi: 10.5888/pcd11.130415.
• Rosenberg VA, Eglinton GS, Rauch ER, Skupski DW. Intrapartum maternal glycemic control in women with insulin requiring diabetes: a randomized clinical trial of rotating fluids versus insulin drip. Am J Obstet Gynecol. 2006 Oct;195(4):1095-9. doi: 10.1016/j.ajog.2006.05.051. Epub 2006 Aug 8.
• Golde SH, Good-Anderson B, Montoro M, Artal R. Insulin requirements during labor: a reappraisal. Am J Obstet Gynecol. 1982 Nov 1;144(5):556-9. doi: 10.1016/0002-9378(82)90227-7.
• HAPO Study Cooperative Research Group; Metzger BE, Lowe LP, Dyer AR, Trimble ER, Chaovarindr U, Coustan DR, Hadden DR, McCance DR, Hod M, McIntyre HD, Oats JJ, Persson B, Rogers MS, Sacks DA. Hyperglycemia and adverse pregnancy outcomes. N Engl J Med. 2008 May 8;358(19):1991-2002. doi: 10.1056/NEJMoa0707943.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2019
• Primary Completion (Estimated): February 28, 2024
• Study Completion (Estimated): April 1, 2024

Study Registration Dates

• First Submitted: April 9, 2019
• First Submitted That Met QC Criteria: April 10, 2019
• First Posted (Actual): April 11, 2019

Study Record Updates

• Last Update Posted (Estimated): January 18, 2024
• Last Update Submitted That Met QC Criteria: January 17, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: diabetes; insulin; glycemic control; intrapartum
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Diabetes, Gestational; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin
• Other Study ID Numbers: 2018-0502

Drug and device information, study documents

• 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