Clinical trial NCT05647798: Intrapartum Glycemic Control in GDMA2
Official title: Management of Intrapartum Glycemia in Gestational Diabetic Mothers: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Pregnancy
Gestational Diabetes Mellitus, Class A2
Neonatal Hypoglycemia
Keywords: Intrapartum Glycemia
Labor
Lead sponsor: Inova Health Care Services
Sponsor class: OTHER
First posted: 2022-12-13
Enrollment: 2
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Initial neonatal glucose post delivery
timeFrame: first 2 hours of life
Secondary outcomes:
measure: Neonatal hypoglycemia
timeFrame: Birth of newborn until discharge to home or up to 7 days, whichever occurs first
measure: Neonatal hypoglycemia requiring neonatal intensive care unit (NICU)
timeFrame: Birth of newborn until discharge to home or up to 7 days, whichever occurs first
measure: Mean neonatal glucose within the first 24 hours post-delivery
timeFrame: First 24 hours after delivery
measure: Neonatal intensive care unit admission
timeFrame: Birth of newborn until discharge to home or up to 7 days, whichever occurs first
measure: Neonatal intensive care unit length of stay
timeFrame: Birth of newborn until discharge to home or up to 7 days, whichever occurs first
measure: Neonatal jaundice requiring phototherapy
timeFrame: Birth of newborn until discharge to home or up to 7 days, whichever occurs first
measure: Mother's childbirth experience score
timeFrame: Intrapartum
Other outcomes:
measure: Number of intrapartum glycemia checks
timeFrame: Intrapartum
measure: Intrapartum glycemia mean
timeFrame: Intrapartum
measure: Intrapartum insulin use
timeFrame: Intrapartum
measure: Intrapartum insulin dose (total)
timeFrame: Intrapartum
Locations:
city: Falls Church
country: United States
facility: Inova Fairfax Medical campus
state: Virginia
city: Falls Church
country: United States
facility: Inova Health Care Services
state: Virginia
Study officials:
affiliation: Inova Healthcare Services
name: Jean W Thermolice, MD
role: PRINCIPAL_INVESTIGATOR
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