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Clinical Trial NCT05553275 for Gestational Diabetes, Pregestational Diabetes is completed. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Permissive Intrapartum Glucose Control 96
Clinical Trial NCT05553275 was an interventional study for Gestational Diabetes, Pregestational Diabetes that is now completed. The study started on 5 October 2022, with plans to enroll 96 participants. Led by The University of Texas Health Science Center, Houston, the expected completion date was 13 August 2023. The latest data from ClinicalTrials.gov was last updated on 14 May 2024.
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.
Official Title
Permissive Intrapartum Glucose Control: An Equivalence Randomized Control Study (PERMIT)
Conditions
Gestational DiabetesPregestational DiabetesOther Study IDs
- HSC-MS-22-0577
NCT ID Number
Start Date (Actual)
2022-10-05
Last Update Posted
2024-05-14
Completion Date (Estimated)
2023-08-13
Enrollment (Estimated)
96
Study Type
Interventional
PHASE
N/A
Status
Completed
Keywords
Diabetes Mellitus
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
Active ComparatorGroup 1:Usual Care | 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...Show More |
ExperimentalGroup 2: Permissive Care | 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 norm...Show More |
Primary Outcome Measures
Secondary 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 |
| 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 |
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
Female
- 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
- 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)
The University of Texas Health Science Center, HoustonStudy Responsible Party
Ghamar Bitar, Principal Investigator, Fellow, The University of Texas Health Science Center, Houston
No contact data.
1 Study Locations in 1 Countries
Texas
The University of Texas Health Science Center at Houston, Houston, Texas, 77030, United States