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Completed

NCT Number: NCT05553275

Permissive Intrapartum Glucose Control

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.

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Key information

Conditions

Gestational Diabetes Diabetes Mellitus Diabetes, Gestational Endocrine System Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Pregestational Diabetes Pregnancy Complications Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

usual care

Procedure

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

Permissive intrapartum glucose control

Procedure

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 outcomes

  1. first neonatal blood glucose level measured in mg/dL

    Time frame: up to 2 hours of life prior to first feed

Secondary outcomes

  1. Number of intrapartum glucose measurements

    Time frame: During Labor(for up to 200 hours)

  2. Mean maternal glucose values in mg/dl

    Time frame: during latent labor(for up to 200 hours)

  3. Mean maternal glucose values in mg/dl

    Time frame: during active labor(for up to 200 hours)

  4. Overall mean maternal glucose values in mg/dl

    Time frame: in all of labor(for up to 200 hours)

  5. Number of participants that have hyperglycemia episodes

    Time frame: during labor( for up to 200 hours)

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

  6. Number of participants that have hypoglycemia episodes

    Time frame: 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

  7. Number of participants that have Diabetic Ketoacidosis

    Time frame: during labor(for up to 200 hours)

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

  8. Maximum insulin Glucose tolerance test (GTT) rate

    Time frame: during labor(for up to 200 hours)

  9. Number of participants that utilize insulin drip

    Time frame: during labor(for up to 200 hours)

  10. Number of participants that undergo primary cesarean section

    Time frame: at time of delivery

  11. Number of participants that have Postpartum hemorrhage

    Time frame: from discharge until 6 months after birth

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

  12. Number pf participants that have Intra-amniotic Infection

    Time frame: intrapartum or within 24 hours of delivery

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

  13. Number pf participants that have endometriosis

    Time frame: Between 24 hours after delivery to 6 weeks of delivery

    Endometritis is defined as clinically diagnosed uterine infection

  14. Number pf participants that have wound complications

    Time frame: within 6 weeks of delivery

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

  15. Number pf participants that require blood product transfusion

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

  16. 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

  17. 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

  18. 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)

  19. 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

  20. 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

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

    Time frame: within 6- 8 weeks of delivery

  22. Neonatal C-peptide levels from cord blood

    Time frame: at time of delivery

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

    Time frame: within the first 24 hours of life

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

    Time frame: during birth admission defined as birth time of neonate until neonate is discharged from hospital, up to 1 year

  25. Number of neonates that need oral glucose supplementation

    Time frame: during birth admission defined as birth time of neonate until neonate is discharged from hospital, up to 1 year

  26. Number of neonates that need IV glucose

    Time frame: during birth admission defined as birth time of neonate until neonate is discharged from hospital, up to 1 year

  27. Lowest neonatal glucose level

    Time frame: during birth admission defined as birth time of neonate until neonate is discharged from hospital, up to 1 year

  28. Mean neonatal glucose level in first 24 hours of life

    Time frame: during birth admission defined as birth time of neonate until neonate is discharged from hospital, up to 1 year

  29. Lowest neonatal glucose level

    Time frame: first 24 hours of life

  30. Number of neonates that required shoulder dystocia

    Time frame: 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

  31. Number of neonates that had birth injury

    Time frame: 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

  32. Number of neonates that had respiratory distress

    Time frame: 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

  33. Number of fetal deaths

    Time frame: during labor defined as time patient is admitted to labor and delivery until birth time of neonate, for up to 200 hours

  34. Number of neonatal deaths

    Time frame: within 28 days of birth

  35. Number of neonates with Apgar score of less than 7

    Time frame: 5 minutes from birth

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

    Time frame: from birth up to 6 months from birth

  37. Number of days neonates are admitted to NICU

    Time frame: from birth up to 6 months from birth

  38. Number of neonates that have neonatal hyperbilirubinemia requiring phototherapy

    Time frame: during admission defined as birth time of neonate until neonate is discharged from hospital, up to 1 year

  39. Maximum Bilirubin level

    Time frame: during admission defined as birth time of neonate until neonate is discharged from hospital, up to 1 year

  40. Number of neonates that have hypocalcemia

    Time frame: during admission defined as birth time of neonate until neonate is discharged from hospital, up to 1 year

  41. Number of neonates that have Necrotizing Enterocolitis

    Time frame: from birth up to 6 months from birth

  42. Number of neonates that are small for gestational age

    Time frame: at birth

    Small for gestational age is defined as a weight below 10th percentile of the expected value according to gestational age

  43. Number of neonates that are large for gestational age

    Time frame: at birth

    Large for gestational age is defined as a weight above 90th percentile of the expected value according to gestational age

  44. Number of neonates that have Macrosomia

    Time frame: at time of birth

    Macrosomia is defined as weight more than 4000 grams

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Sep 23, 2022
Registry last updated
May 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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