Clinical trial NCT05553275: Permissive Intrapartum Glucose Control
Official title: Permissive Intrapartum Glucose Control: An Equivalence Randomized Control Study (PERMIT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gestational Diabetes
Pregestational Diabetes
Keywords: Diabetes Mellitus
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2022-09-23
Enrollment: 96
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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)

Primary outcomes:
measure: first neonatal blood glucose level measured in mg/dL
timeFrame: up to 2 hours of life prior to first feed
Secondary outcomes:
measure: Number of intrapartum glucose measurements
timeFrame: During Labor(for up to 200 hours)
measure: Mean maternal glucose values in mg/dl
timeFrame: during latent labor(for up to 200 hours)
measure: Mean maternal glucose values in mg/dl
timeFrame: during active labor(for up to 200 hours)
measure: Overall mean maternal glucose values in mg/dl
timeFrame: in all of labor(for up to 200 hours)
measure: Number of participants that have hyperglycemia episodes
timeFrame: during labor( for up to 200 hours)
measure: Number of participants that have hypoglycemia episodes
timeFrame: during labor(for up to 200 hours)
measure: Number of participants that have Diabetic Ketoacidosis
timeFrame: during labor(for up to 200 hours)
measure: Maximum insulin Glucose tolerance test (GTT) rate
timeFrame: during labor(for up to 200 hours)
measure: Number of participants that utilize insulin drip
timeFrame: during labor(for up to 200 hours)
measure: Number of participants that undergo primary cesarean section
timeFrame: at time of delivery
measure: Number of participants that have Postpartum hemorrhage
timeFrame: from discharge until 6 months after birth
measure: Number pf participants that have Intra-amniotic Infection
timeFrame: intrapartum or within 24 hours of delivery
measure: Number pf participants that have endometriosis
timeFrame: Between 24 hours after delivery to 6 weeks of delivery
measure: Number pf participants that have wound complications
timeFrame: within 6 weeks of delivery
measure: Number pf participants that require blood product transfusion
timeFrame: during admission (for up to 6 weeks after neonate delivery)
measure: Resource utilization during labor as assessed by the number of accuchecks done
timeFrame: 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
measure: Resource utilization during labor as assessed by the number of nurses utilized
timeFrame: 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
measure: Total facility and physician costs for all the services provided to the mothers
timeFrame: From maternal admission time to maternal discharge time(upto 6 months form admission date)
measure: Total facility and physician costs for all the services provided to the neonates
timeFrame: from birth time to discharge time defined as birth time of neonate until neonate is discharged from the hospital, up to 1 year
measure: Total nurse time cost for monitoring the patients during labor
timeFrame: 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
measure: Number of gestational diabetes participants that do an oral glucose tolerance test (OGTT)
timeFrame: within 6- 8 weeks of delivery
measure: Neonatal C-peptide levels from cord blood
timeFrame: at time of delivery
measure: Number of neonates that have blood glucose level less than 40 mg/dL
timeFrame: within the first 24 hours of life
measure: Number of neonates that have blood glucose level less than 40 mg/dL
timeFrame: during birth admission defined as birth time of neonate until neonate is discharged from hospital, up to 1 year
measure: Number of neonates that need oral glucose supplementation
timeFrame: during birth admission defined as birth time of neonate until neonate is discharged from hospital, up to 1 year
measure: Number of neonates that need IV glucose
timeFrame: during birth admission defined as birth time of neonate until neonate is discharged from hospital, up to 1 year
measure: Lowest neonatal glucose level
timeFrame: during birth admission defined as birth time of neonate until neonate is discharged from hospital, up to 1 year
measure: Mean neonatal glucose level in first 24 hours of life
timeFrame: during birth admission defined as birth time of neonate until neonate is discharged from hospital, up to 1 year
measure: Lowest neonatal glucose level
timeFrame: first 24 hours of life
measure: Number of neonates that required shoulder dystocia
timeFrame: at time of delivery
measure: Number of neonates that had birth injury
timeFrame: from birth and during admission defined as birth time of neonate until neonate is discharged from hospital, up to 1 year
measure: Number of neonates that had respiratory distress
timeFrame: first 24 hours of life
measure: Number of fetal deaths
timeFrame: during labor defined as time patient is admitted to labor and delivery until birth time of neonate, for up to 200 hours
measure: Number of neonatal deaths
timeFrame: within 28 days of birth
measure: Number of neonates with Apgar score of less than 7
timeFrame: 5 minutes from birth
measure: Number of neonates that are admitted to Neonatal intensive care unit (NICU)
timeFrame: from birth up to 6 months from birth
measure: Number of days neonates are admitted to NICU
timeFrame: from birth up to 6 months from birth
measure: Number of neonates that have neonatal hyperbilirubinemia requiring phototherapy
timeFrame: during admission defined as birth time of neonate until neonate is discharged from hospital, up to 1 year
measure: Maximum Bilirubin level
timeFrame: during admission defined as birth time of neonate until neonate is discharged from hospital, up to 1 year
measure: Number of neonates that have hypocalcemia
timeFrame: during admission defined as birth time of neonate until neonate is discharged from hospital, up to 1 year
measure: Number of neonates that have Necrotizing Enterocolitis
timeFrame: from birth up to 6 months from birth
measure: Number of neonates that are small for gestational age
timeFrame: at birth
measure: Number of neonates that are large for gestational age
timeFrame: at birth
measure: Number of neonates that have Macrosomia
timeFrame: at time of birth
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Ghamar Bitar, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The University of Texas Health Science Center, Houston
name: Michal F Bartar, MD
role: PRINCIPAL_INVESTIGATOR
References: