Permissive Intrapartum Glucose Control

Study Overview
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Brief Summary
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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.

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

Conditions
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Gestational Diabetes, Pregestational Diabetes

Intervention / Treatment
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* Procedure: Usual Care
* Procedure: Permissive intrapartum glucose control


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1:Usual Care<br> | Procedure: Usual Care<br>* 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<br>|
| Experimental: Group 2: Permissive Care<br> | Procedure: Permissive intrapartum glucose control<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes Mellitus