Permissive Intrapartum Glucose Control

NCT05553275 | Completed

• 1 other identifier: HSC-MS-22-0577
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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.

Conditions

Gestational Diabetes; Pregestational Diabetes

Keywords

Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• first neonatal blood glucose level measured in mg/dL

  up to 2 hours of life prior to first feed

Secondary Outcomes (44)

• 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

  during labor( for up to 200 hours)

Study Arms (2)

Group 1:Usual Care

ACTIVE COMPARATOR

Procedure: Usual Care

Group 2: Permissive Care

EXPERIMENTAL

Procedure: Permissive intrapartum glucose control

Interventions

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

Group 1:Usual Care

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.

Group 2: Permissive Care

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Diabetes, Gestational; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Ghamar Bitar, MD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

• Michal F Bartar, MD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Fellow

Study Record Dates

• First Submitted: September 9, 2022
• First Posted: September 23, 2022
• Study Start: October 5, 2022
• Primary Completion: July 2, 2023
• Study Completion: August 13, 2023
• Last Updated: May 14, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)