Permissive Intrapartum Glucose Control

Permissive Intrapartum Glucose Control: An Equivalence Randomized Control Study (PERMIT)

The purpose of this study is to assess whether permissive intrapartum glycemic control compared to usual care would lead to similar rate of neonatal hypoglycemia among people with diabetes.

Study Overview

• Status: Completed
• Conditions: Gestational Diabetes; Pregestational Diabetes
• Intervention / Treatment: Procedure: Usual Care; Procedure: Permissive intrapartum glucose control

• Study Type: Interventional
• Enrollment (Actual): 96
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • The University of Texas Health Science Center at Houston

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Singleton gestation
• Presenting for intrapartum management (induction, labor, augmentation)
• Any diagnosis of Type 1 Diabetes Mellitus(T1DM), Type 2 Diabetes Mellitus (T2DM), or Gestational Diabetes
• English or Spanish fluency

Exclusion Criteria:

• Major fetal anomalies affecting glucose metabolism
• Multiple Gestation
• Incarcerated subjects
• less than 34 weeks gestation of pregnancy
• Planned cesarean delivery
• Utilizing insulin pump during labor
• Stillbirth
• Presenting in Diabetic ketoacidosis(DKA)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group 1:Usual Care	Procedure: Usual Care; Blood sugar evaluation (accuchecks) every four hours in latent labor and every 2 hours in active labor.Participants will be routinely managed with maintenance fluids of lactated ringers during latent labor and lactated ringers with dextrose 5% in active labor. Blood sugars of more than 110 mg/dl at any time point in labor will be treated with an insulin drip as follows: Regular insulin (100 units) in 100cc of normal saline, with Lactated Ringers with 5% dextrose at 125cc/hour. If blood sugar 111-140, insulin drip at 1 unit/hour will be given and continued if blood sugar is 111-140.If blood sugar is 141-180, then drip will be changed to to 1.5 unit/hour and if blood sugar is 181-220, drip will be changed to 2.0 units/hour and MD will be called if blood sugar is more than 221 mg/dl
Experimental: Group 2: Permissive Care	Procedure: Permissive intrapartum glucose control; Blood sugar evaluation (accuchecks) every four hours in latent labor and every 2 hours in active labor.Participants will be routinely management with maintenance fluids of lactated ringers during latent labor and lactated ringers with dextrose 5% in active labor.Blood sugars of more than 180 mg/dl at any time point in labor will be treated with an insulin drip as follows: Regular insulin (100 units) in 100cc of normal saline, with Lactated Ringers with 5% dextrose at 125cc/hour.If blood sugar is 181-200, insulin drip at 1 unit/hour will be given. If blood sugar is 201-220, then drip will be changed to 1.5 units/hour. If blood sugar is 221 - 250, then drip will be changed to 2.0 units/hour and if blood sugar is more than 251 MD will be called.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
first neonatal blood glucose level measured in mg/dL	up to 2 hours of life prior to first feed

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of intrapartum glucose measurements		During Labor(for up to 200 hours)
Mean maternal glucose values in mg/dl		during latent labor(for up to 200 hours)
Mean maternal glucose values in mg/dl		during active labor(for up to 200 hours)
Overall mean maternal glucose values in mg/dl		in all of labor(for up to 200 hours)
Number of participants that have hyperglycemia episodes	Hyperglycemia is defined as blood sugar levels greater than 200 mg/dl	during labor( for up to 200 hours)
Number of participants that have hypoglycemia episodes	Hypoglycemia is defined as blood sugar levels less than or equal to 60 mg/dl or symptomatic or requiring IV dextrose	during labor(for up to 200 hours)
Number of participants that have Diabetic Ketoacidosis	Diabetic Ketoacidosis includes uncontrolled hyperglycemia, anion gap metabolic acidosis, and ketosis	during labor(for up to 200 hours)
Maximum insulin Glucose tolerance test (GTT) rate		during labor(for up to 200 hours)
Number of participants that utilize insulin drip		during labor(for up to 200 hours)
Number of participants that undergo primary cesarean section		at time of delivery
Number of participants that have Postpartum hemorrhage	Postpartum hemorrhage is defined as greater than or equal to 1000ml or need for blood transfusion	from discharge until 6 months after birth
Number pf participants that have Intra-amniotic Infection	Intra-amniotic Infection is defined as clinically diagnosed infection of the uterine environment	intrapartum or within 24 hours of delivery
Number pf participants that have endometriosis	Endometritis is defined as clinically diagnosed uterine infection	Between 24 hours after delivery to 6 weeks of delivery
Number pf participants that have wound complications	Wound complications is defined as superficial or deep infections, fascial dehiscence	within 6 weeks of delivery
Number pf participants that require blood product transfusion		during admission (for up to 6 weeks after neonate delivery)
Resource utilization during labor as assessed by the number of accuchecks done		during delivery admission (labor or induction/augmentation) until delivery defined as time patient is admitted to labor and delivery until birth time of neonate, for up to 200 hours
Resource utilization during labor as assessed by the number of nurses utilized		during delivery admission (labor or induction/augmentation) until delivery defined as time patient is admitted to labor and delivery until birth time of neonate, for up to 200 hours
Total facility and physician costs for all the services provided to the mothers		From maternal admission time to maternal discharge time(upto 6 months form admission date)
Total facility and physician costs for all the services provided to the neonates		from birth time to discharge time defined as birth time of neonate until neonate is discharged from the hospital, up to 1 year
Total nurse time cost for monitoring the patients during labor		From admission time to delivery time defined as time patient is admitted to labor and delivery until birth time of neonate, for up to 200 hours
Number of gestational diabetes participants that do an oral glucose tolerance test (OGTT)		within 6- 8 weeks of delivery
Neonatal C-peptide levels from cord blood		at time of delivery
Number of neonates that have blood glucose level less than 40 mg/dL		within the first 24 hours of life
Number of neonates that have blood glucose level less than 40 mg/dL		during birth admission defined as birth time of neonate until neonate is discharged from hospital, up to 1 year
Number of neonates that need oral glucose supplementation		during birth admission defined as birth time of neonate until neonate is discharged from hospital, up to 1 year
Number of neonates that need IV glucose		during birth admission defined as birth time of neonate until neonate is discharged from hospital, up to 1 year
Lowest neonatal glucose level		during birth admission defined as birth time of neonate until neonate is discharged from hospital, up to 1 year
Mean neonatal glucose level in first 24 hours of life		during birth admission defined as birth time of neonate until neonate is discharged from hospital, up to 1 year
Lowest neonatal glucose level		first 24 hours of life
Number of neonates that required shoulder dystocia	Shoulder dystocia is defined as the need for any extra maneuvers, other than gentle downward traction of the fetal head to deliver the fetal body after the fetal head has been delivered	at time of delivery
Number of neonates that had birth injury	Birth injury as defined as skull, clavicular, humerus fracture, or brachial plexus	from birth and during admission defined as birth time of neonate until neonate is discharged from hospital, up to 1 year
Number of neonates that had respiratory distress	Respiratory distress is defined as the need for at least 4 hours of respiratory support with supplemental oxygen, continuous positive airway pressure, or ventilation	first 24 hours of life
Number of fetal deaths		during labor defined as time patient is admitted to labor and delivery until birth time of neonate, for up to 200 hours
Number of neonatal deaths		within 28 days of birth
Number of neonates with Apgar score of less than 7		5 minutes from birth
Number of neonates that are admitted to Neonatal intensive care unit (NICU)		from birth up to 6 months from birth
Number of days neonates are admitted to NICU		from birth up to 6 months from birth
Number of neonates that have neonatal hyperbilirubinemia requiring phototherapy		during admission defined as birth time of neonate until neonate is discharged from hospital, up to 1 year
Maximum Bilirubin level		during admission defined as birth time of neonate until neonate is discharged from hospital, up to 1 year
Number of neonates that have hypocalcemia		during admission defined as birth time of neonate until neonate is discharged from hospital, up to 1 year
Number of neonates that have Necrotizing Enterocolitis		from birth up to 6 months from birth
Number of neonates that are small for gestational age	Small for gestational age is defined as a weight below 10th percentile of the expected value according to gestational age	at birth
Number of neonates that are large for gestational age	Large for gestational age is defined as a weight above 90th percentile of the expected value according to gestational age	at birth
Number of neonates that have Macrosomia	Macrosomia is defined as weight more than 4000 grams	at time of birth

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Investigators: Principal Investigator: Ghamar Bitar, MD, The University of Texas Health Science Center, Houston; Principal Investigator: Michal F Bartar, MD, The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start (Actual): October 5, 2022
• Primary Completion (Actual): July 2, 2023
• Study Completion (Actual): August 13, 2023

Study Registration Dates

• First Submitted: September 9, 2022
• First Submitted That Met QC Criteria: September 20, 2022
• First Posted (Actual): September 23, 2022

Study Record Updates

• Last Update Posted (Actual): May 14, 2024
• Last Update Submitted That Met QC Criteria: May 11, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Diabetes Mellitus
• 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, Gestational
• Other Study ID Numbers: HSC-MS-22-0577

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No