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

Brief Summary

Primary Outcomes

Secondary Outcomes

• Number of neonatal deaths(within 28 days of birth)
• Number of neonates with Apgar score of less than 7(5 minutes from birth)
• Neonatal C-peptide levels from cord blood(at time of delivery)
• Maximum Bilirubin level(during admission defined as birth time of neonate until neonate is discharged from hospital, up to 1 year)
• Number of participants that undergo primary cesarean section(at time of delivery)
• 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)
• Number of intrapartum glucose measurements(During Labor(for up to 200 hours))
• Number of gestational diabetes participants that do an oral glucose tolerance test (OGTT)(within 6- 8 weeks of delivery)
• Lowest neonatal glucose level(first 24 hours of life)
• Number of neonates that required shoulder dystocia(at time of delivery)
• 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 neonates that are admitted to Neonatal intensive care unit (NICU)(from birth up to 6 months from birth)
• Overall mean maternal glucose values in mg/dl(in all of labor(for up to 200 hours))
• Number of participants that have hyperglycemia episodes(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 have Postpartum hemorrhage(from discharge until 6 months after birth)
• 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)
• 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)
• Mean maternal glucose values in mg/dl(during active labor(for up to 200 hours))
• Number of participants that have hypoglycemia episodes(during labor(for up to 200 hours))
• Number of participants that have Diabetic Ketoacidosis(during labor(for up to 200 hours))
• Number pf participants that have Intra-amniotic Infection(intrapartum or within 24 hours of delivery)
• Number pf participants that have endometriosis(Between 24 hours after delivery to 6 weeks of delivery)
• Number pf participants that require blood product transfusion(during admission (for up to 6 weeks after neonate delivery))
• 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 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 neonates that had birth injury(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 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)
• Number of participants that utilize insulin drip(during labor(for up to 200 hours))
• Number pf participants that have wound complications(within 6 weeks of delivery)
• 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)
• 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 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 had respiratory distress(first 24 hours of life)
• Number of days neonates are admitted to NICU(from birth up to 6 months from birth)
• Number of neonates that are small for gestational age(at 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)
• Number of neonates that have Necrotizing Enterocolitis(from birth up to 6 months from birth)
• Number of neonates that are large for gestational age(at birth)
• Number of neonates that have Macrosomia(at time of birth)