An interventional study of Blood sugar check every 2 hours and Blood sugar check every 4 hours in Pregnancy, Gestational Diabetes Mellitus, Class A2 and Neonatal Hypoglycemia, sponsored by Inova Health Care Services. Terminated at 2 sites in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-06-04.
Sponsored by Inova Health Care Services · Not applicable, Interventional, and Other
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.
857 studies on the registry are indexed under Diabetes, Gestational; 199 are open to participants now.
This study's enrollment of 2 is below the median of 110 across 560 interventional studies indexed under Diabetes, Gestational.
Browse Diabetes, Gestational studies →Inova Health Care Services is the lead sponsor of 85 studies on the registry; 19 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 8 (80%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Blood glucose will be checked every 2 hours during labor and glucose target will be 75-110 mg/dl
Other: Blood sugar check every 2 hours
Blood glucose will be checked every 4 hours during labor and glucose target will be 70-126 mg/dl
Other: Blood sugar check every 4 hours
Blood sugar check every 2 hours
Blood sugar check every 4 hours
Initial neonatal glucose post delivery
First blood sugar recorded in newborn after delivery
Time frame: first 2 hours of life
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
Time frame: Birth of newborn until discharge to home or up to 7 days, whichever occurs first
Mother's childbirth experience score
Mother's experience of labor assessed by the Labor and Delivery Index (LADY-X) per Gartner et al.
Time frame: Intrapartum
Number of intrapartum glycemia checks
Total number of blood sugar checks during labor
Time frame: Intrapartum
Intrapartum glycemia mean
Average maternal blood sugar during labor
Time frame: Intrapartum
Intrapartum insulin use
Use of insulin during labor
Time frame: Intrapartum
Intrapartum insulin dose (total)
Total insulin dose used during labor
Time frame: Intrapartum
Ran from May 2023 to primary completion in May 2024, 11 months.
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This study is terminated, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
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Inova Health Care Services