Permissive Intrapartum Glucose Control

Not Applicable

Completed

• Conditions: Pregestational Diabetes; Gestational Diabetes
• Interventions: Procedure: Permissive intrapartum glucose control; Procedure: Usual Care

• Registration Number: NCT05553275
• Lead Sponsor: The University of Texas Health Science Center, Houston

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-09-09
• Study First Submitted QC: 2022-09-20
• Study First Posted: 2022-09-23
• Study Start: 2022-10-05
• Primary Completion: 2023-07-02
• Study Completion: 2023-08-13
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-11
• Last Update Posted: 2024-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 96

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2: Permissive Care	Permissive intrapartum glucose control	-
Group 1:Usual Care	Usual Care	-

Primary Outcome Measures

Name	Time	Method
first neonatal blood glucose level measured in mg/dL	up to 2 hours of life prior to first feed

Secondary Outcome Measures

Name	Time	Method
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	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
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)	Hyperglycemia is defined as blood sugar levels greater than 200 mg/dl
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	Postpartum hemorrhage is defined as greater than or equal to 1000ml or need for blood transfusion
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)	Hypoglycemia is defined as blood sugar levels less than or equal to 60 mg/dl or symptomatic or requiring IV dextrose
Number of participants that have Diabetic Ketoacidosis	during labor(for up to 200 hours)	Diabetic Ketoacidosis includes uncontrolled hyperglycemia, anion gap metabolic acidosis, and ketosis
Number pf participants that have Intra-amniotic Infection	intrapartum or within 24 hours of delivery	Intra-amniotic Infection is defined as clinically diagnosed infection of the uterine environment
Number pf participants that have endometriosis	Between 24 hours after delivery to 6 weeks of delivery	Endometritis is defined as clinically diagnosed uterine infection
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	Birth injury as defined as skull, clavicular, humerus fracture, or brachial plexus
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	Wound complications is defined as superficial or deep infections, fascial dehiscence
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 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 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	Respiratory distress is defined as the need for at least 4 hours of respiratory support with supplemental oxygen, continuous positive airway pressure, or ventilation
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	Small for gestational age is defined as a weight below 10th percentile of the expected value according to gestational age
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	Large for gestational age is defined as a weight above 90th percentile of the expected value according to gestational age
Number of neonates that have Macrosomia	at time of birth	Macrosomia is defined as weight more than 4000 grams

Trial Locations

Locations (1)

The University of Texas Health Science Center at Houston; 🇺🇸 Houston, Texas, United States