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Permissive Intrapartum Glucose Control

Primary Purpose

Gestational Diabetes, Pregestational Diabetes

Status

Active

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Usual Care

Permissive intrapartum glucose control

About this trial

This is an interventional treatment trial for Gestational Diabetes focused on measuring Diabetes Mellitus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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)

Sites / Locations

The University of Texas Health Science Center at Houston

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Group 1:Usual Care

Group 2: Permissive Care

Arm Description

Outcomes

Primary Outcome Measures

first neonatal blood glucose level measured in mg/dL

Secondary Outcome Measures

Number of intrapartum glucose measurements

Mean maternal glucose values in mg/dl

Overall mean maternal glucose values in mg/dl

Number of participants that have hyperglycemia episodes

Hyperglycemia is defined as blood sugar levels greater than 200 mg/dl

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

Number of participants that have Diabetic Ketoacidosis

Diabetic Ketoacidosis includes uncontrolled hyperglycemia, anion gap metabolic acidosis, and ketosis

Maximum insulin Glucose tolerance test (GTT) rate

Number of participants that utilize insulin drip

Number of participants that undergo primary cesarean section

Number of participants that have Postpartum hemorrhage

Postpartum hemorrhage is defined as greater than or equal to 1000ml or need for blood transfusion

Number pf participants that have Intra-amniotic Infection

Intra-amniotic Infection is defined as clinically diagnosed infection of the uterine environment

Number pf participants that have endometriosis

Endometritis is defined as clinically diagnosed uterine infection

Number pf participants that have wound complications

Wound complications is defined as superficial or deep infections, fascial dehiscence

Number pf participants that require blood product transfusion

Resource utilization during labor as assessed by the number of accuchecks done

Resource utilization during labor as assessed by the number of nurses utilized

Total facility and physician costs for all the services provided to the mothers

Total facility and physician costs for all the services provided to the neonates

Total nurse time cost for monitoring the patients during labor

Number of gestational diabetes participants that do an oral glucose tolerance test (OGTT)

Neonatal C-peptide levels from cord blood

Number of neonates that have blood glucose level less than 40 mg/dL

Number of neonates that need oral glucose supplementation

Number of neonates that need IV glucose

Lowest neonatal glucose level

Mean neonatal glucose level in first 24 hours of life

Lowest neonatal glucose level

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

Number of neonates that had birth injury

Birth injury as defined as skull, clavicular, humerus fracture, or brachial plexus

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

Number of fetal deaths

Number of neonatal deaths

Number of neonates with Apgar score of less than 7

Number of neonates that are admitted to Neonatal intensive care unit (NICU)

Number of days neonates are admitted to NICU

Number of neonates that have neonatal hyperbilirubinemia requiring phototherapy

Maximum Bilirubin level

Number of neonates that have hypocalcemia

Number of neonates that have Necrotizing Enterocolitis

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

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

Number of neonates that have Macrosomia

Macrosomia is defined as weight more than 4000 grams

Full Information

NCT ID

NCT05553275

First Posted

September 9, 2022

Last Updated

July 17, 2023

Sponsor

The University of Texas Health Science Center, Houston

1. Study Identification

Unique Protocol Identification Number

NCT05553275

Brief Title

Permissive Intrapartum Glucose Control

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

October 5, 2022 (Actual)

Primary Completion Date

July 2, 2023 (Actual)

Study Completion Date

March 6, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

The University of Texas Health Science Center, Houston

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gestational Diabetes, Pregestational Diabetes

Keywords

Diabetes Mellitus

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

96 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Group 1:Usual Care

Arm Type

Active Comparator

Arm Title

Group 2: Permissive Care

Arm Type

Experimental

Intervention Type

Procedure

Intervention Name(s)

Usual Care

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

Permissive intrapartum glucose control

Intervention Description

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.

Primary Outcome Measure Information:

Title

first neonatal blood glucose level measured in mg/dL

Time Frame

up to 2 hours of life prior to first feed

Secondary Outcome Measure Information:

Title

Number of intrapartum glucose measurements

Time Frame

During Labor(for up to 200 hours)

Title

Mean maternal glucose values in mg/dl

Time Frame

during latent labor(for up to 200 hours)

Title

Mean maternal glucose values in mg/dl

Time Frame

during active labor(for up to 200 hours)

Title

Overall mean maternal glucose values in mg/dl

Time Frame

in all of labor(for up to 200 hours)

Title

Number of participants that have hyperglycemia episodes

Description

Hyperglycemia is defined as blood sugar levels greater than 200 mg/dl

Time Frame

during labor( for up to 200 hours)

Title

Number of participants that have hypoglycemia episodes

Description

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)

Title

Number of participants that have Diabetic Ketoacidosis

Description

Diabetic Ketoacidosis includes uncontrolled hyperglycemia, anion gap metabolic acidosis, and ketosis

Time Frame

during labor(for up to 200 hours)

Title

Maximum insulin Glucose tolerance test (GTT) rate

Time Frame

during labor(for up to 200 hours)

Title

Number of participants that utilize insulin drip

Time Frame

during labor(for up to 200 hours)

Title

Number of participants that undergo primary cesarean section

Time Frame

at time of delivery

Title

Number of participants that have Postpartum hemorrhage

Description

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

Title

Number pf participants that have Intra-amniotic Infection

Description

Intra-amniotic Infection is defined as clinically diagnosed infection of the uterine environment

Time Frame

intrapartum or within 24 hours of delivery

Title

Number pf participants that have endometriosis

Description

Endometritis is defined as clinically diagnosed uterine infection

Time Frame

Between 24 hours after delivery to 6 weeks of delivery

Title

Number pf participants that have wound complications

Description

Wound complications is defined as superficial or deep infections, fascial dehiscence

Time Frame

within 6 weeks of delivery

Title

Number pf participants that require blood product transfusion

Time Frame

during admission (for up to 6 weeks after neonate delivery)

Title

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

Title

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

Title

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)

Title

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

Title

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

Title

Number of gestational diabetes participants that do an oral glucose tolerance test (OGTT)

Time Frame

within 6- 8 weeks of delivery

Title

Neonatal C-peptide levels from cord blood

Time Frame

at time of delivery

Title

Number of neonates that have blood glucose level less than 40 mg/dL

Time Frame

within the first 24 hours of life

Title

Number of neonates that have blood glucose level less than 40 mg/dL

Time Frame