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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
96
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
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.
The University of Texas Health Science Center at Houston
Houston, Texas, United States
first neonatal blood glucose level measured in mg/dL
Time frame: up to 2 hours of life prior to first feed
Number of intrapartum glucose measurements
Time frame: During Labor(for up to 200 hours)
Mean maternal glucose values in mg/dl
Time frame: during latent labor(for up to 200 hours)
Mean maternal glucose values in mg/dl
Time frame: during active labor(for up to 200 hours)
Overall mean maternal glucose values in mg/dl
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: during labor(for up to 200 hours)
Maximum insulin Glucose tolerance test (GTT) rate
Time frame: during labor(for up to 200 hours)
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Number of participants that utilize insulin drip
Time frame: during labor(for up to 200 hours)
Number of participants that undergo primary cesarean section
Time frame: 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
Time frame: 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
Time frame: intrapartum or within 24 hours of delivery
Number pf participants that have endometriosis
Endometritis is defined as clinically diagnosed uterine infection
Time frame: 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
Time frame: within 6 weeks of delivery
Number pf participants that require blood product transfusion
Time frame: during admission (for up to 6 weeks after neonate delivery)
Resource utilization during labor as assessed by the number of accuchecks done
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: within 6- 8 weeks of delivery
Neonatal C-peptide levels from cord blood
Time frame: at time of delivery
Number of neonates that have blood glucose level less than 40 mg/dL
Time frame: within the first 24 hours of life
Number of neonates that have blood glucose level less than 40 mg/dL
Time frame: 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
Time frame: 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
Time frame: during birth admission defined as birth time of neonate until neonate is discharged from hospital, up to 1 year
Lowest neonatal glucose level
Time frame: 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
Time frame: during birth admission defined as birth time of neonate until neonate is discharged from hospital, up to 1 year
Lowest neonatal glucose level
Time frame: 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
Time frame: at time of delivery
Number of neonates that had birth injury
Birth injury as defined as skull, clavicular, humerus fracture, or brachial plexus
Time frame: 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
Time frame: first 24 hours of life
Number of fetal deaths
Time frame: 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
Time frame: within 28 days of birth
Number of neonates with Apgar score of less than 7
Time frame: 5 minutes from birth
Number of neonates that are admitted to Neonatal intensive care unit (NICU)
Time frame: from birth up to 6 months from birth
Number of days neonates are admitted to NICU
Time frame: from birth up to 6 months from birth
Number of neonates that have neonatal hyperbilirubinemia requiring phototherapy
Time frame: during admission defined as birth time of neonate until neonate is discharged from hospital, up to 1 year
Maximum Bilirubin level
Time frame: during admission defined as birth time of neonate until neonate is discharged from hospital, up to 1 year
Number of neonates that have hypocalcemia
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: at birth
Number of neonates that have Macrosomia
Macrosomia is defined as weight more than 4000 grams
Time frame: at time of birth