Intrapartum Glycemic Control in GDMA2

Inova Health Care Services2 enrolled

Overview

This is a randomized, parallel, controlled, non-inferiority trial to assess the impact of a tight versus a more liberalized intrapartum glycemic control in gestational diabetic mothers on neonatal glycemia. National guidelines for the management of intrapartum glucose in women with GDM are lacking. This is likely due to the scarcity of high-quality data on the topic.

Gestational diabetes mellitus (GDM) remains a common pregnancy complication, affecting 6-15% of pregnancies worldwide. The incidence of GDM is expected to continue its global upward trend in light of the growing obesity epidemic and delayed childbearing. GDM is associated with adverse short- and long-term maternal and offspring outcomes. Neonatal hypoglycemia, as a result of fetal hyperinsulinemia, occurs in up to 35% of pregnancies complicated by GDM with potential long-term neurodevelopmental sequelae. In that regard, significant emphasis has been placed on the prevention of neonatal hypoglycemia through optimal maternal glycemic control. Available data are conflicting as to the contribution of intrapartum glycemia to neonatal glycemia. Moreover, national guidelines for the management of intrapartum glucose in women with GDM are lacking. This is likely due to a lack of high-quality data on the topic. As far as we are aware, only one single center randomized controlled trial has been published on the topic. That study's findings suggest that an approach to a more liberalized intrapartum glycemic management was not associated with a higher rate of neonatal hypoglycemia compared to a tight glycemic control regimen. We propose to replicate these findings in a different population at our institution. If this more relaxed approach to intrapartum glycemic management is confirmed to be safe to women and their babies, its clinical application has the potential to decrease the inconvenience of frequent finger pricks for our patients during labor and allow more efficient allocation of resources for the nursing staff on an already labor-intensive unit.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Pregnancy Gestational Diabetes Mellitus, Class A2 Neonatal Hypoglycemia

Interventions

Blood sugar check every 2 hoursOTHER

Blood sugar check every 2 hours

Blood sugar check every 4 hoursOTHER

Blood sugar check every 4 hours

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Women 18 years or older * Non-anomalous singleton gestation * Gestational diabetes type A2 diagnosed at 24 weeks' gestation or beyond * Planned vaginal delivery at term at Inova Fairfax Women's Hospital Exclusion Criteria: * Women \< 18 years * Fetus with major congenital malformations * Twin or higher order gestation * Pre-existing diabetes mellitus * Exposure to antenatal or any systemic steroids 14 days or less prior to delivery * Preterm delivery * Scheduled cesarean birth * Intrapartum cesarean birth prior to 4-5 cm of cervical dilatation

Locations (2)

Inova Fairfax Medical campus

Falls Church, Virginia, United States

Inova Health Care Services

Falls Church, Virginia, United States

Outcomes

Primary Outcomes

Initial neonatal glucose post delivery

First blood sugar recorded in newborn after delivery

Time frame: first 2 hours of life

Secondary Outcomes

Neonatal hypoglycemia

Blood glucose levels \< 40 mg/dl in the first 4 hours of life or \< 45 mg/dl beyond 4 hours of life

Time frame: Birth of newborn until discharge to home or up to 7 days, whichever occurs first

Neonatal hypoglycemia requiring neonatal intensive care unit (NICU)

Blood glucose levels \< 40 mg/dl in the first 4 hours of life or \< 45 mg/dl beyond 4 hours of life that necessitates admission to the neonatal intensive care unit

Time frame: Birth of newborn until discharge to home or up to 7 days, whichever occurs first

Mean neonatal glucose within the first 24 hours post-delivery

Average blood sugar in the newborn during the first 24 hours of life

Time frame: First 24 hours after delivery

Neonatal intensive care unit admission

Any admission to the Neonatal Intensive Care Unit (NICU) within the first 72 hours of delivery

Time frame: Birth of newborn until discharge to home or up to 7 days, whichever occurs first

Neonatal intensive care unit length of stay

Total time spent in the NICU from birth to discharge

Time frame: Birth of newborn until discharge to home or up to 7 days, whichever occurs first

Neonatal jaundice requiring phototherapy

As determined by the Pediatrics provider

Data from ClinicalTrials.gov

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