Gestational Diabetes Mellitus, Class A2, Neonatal Hypoglycemia, Pregnancy
Conditions
Keywords
Intrapartum Glycemia, Labor
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.
Interventions
OTHERBlood sugar check every 2 hours
Blood sugar check every 2 hours
OTHERBlood sugar check every 4 hours
Blood sugar check every 4 hours
Sponsors
Inova Health Care Services
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Initial neonatal glucose post delivery | first 2 hours of life | First blood sugar recorded in newborn after delivery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean neonatal glucose within the first 24 hours post-delivery | First 24 hours after delivery | Average blood sugar in the newborn during the first 24 hours of life |
| Neonatal intensive care unit admission | Birth of newborn until discharge to home or up to 7 days, whichever occurs first | Any admission to the Neonatal Intensive Care Unit (NICU) within the first 72 hours of delivery |
| Neonatal intensive care unit length of stay | Birth of newborn until discharge to home or up to 7 days, whichever occurs first | Total time spent in the NICU from birth to discharge |
| Neonatal jaundice requiring phototherapy | Birth of newborn until discharge to home or up to 7 days, whichever occurs first | As determined by the Pediatrics provider |
| Mother's childbirth experience score | Intrapartum | Mother's experience of labor assessed by the Labor and Delivery Index (LADY-X) per Gartner et al. |
| Neonatal hypoglycemia | Birth of newborn until discharge to home or up to 7 days, whichever occurs first | Blood glucose levels \< 40 mg/dl in the first 4 hours of life or \< 45 mg/dl beyond 4 hours of life |
| Neonatal hypoglycemia requiring neonatal intensive care unit (NICU) | Birth of newborn until discharge to home or up to 7 days, whichever occurs first | 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Intrapartum insulin use | Intrapartum | Use of insulin during labor |
| Intrapartum insulin dose (total) | Intrapartum | Total insulin dose used during labor |
| Number of intrapartum glycemia checks | Intrapartum | Total number of blood sugar checks during labor |
| Intrapartum glycemia mean | Intrapartum | Average maternal blood sugar during labor |
Countries
United States
Outcome results
None listed