Permissive Intrapartum Glucose Control

The University of Texas System (UT)

Status: Completed

Conditions: Pregestational Diabetes; Gestational Diabetes

Treatments: Procedure: Permissive intrapartum glucose control; Procedure: Usual Care

Study type: Interventional

Funder types: Other

Identifiers

NCT05553275

HSC-MS-22-0577

Details and patient eligibility

About

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.

Enrollment: 96 patients

Sex: Female

Ages: 18+ years old

Volunteers: No 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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96 participants in 2 patient groups

Group 1:Usual Care

Active Comparator group

Treatment:

Procedure: Usual Care

Group 2: Permissive Care

Experimental group

Treatment:

Procedure: Permissive intrapartum glucose control