Intrapartum Glycemic Control in GDMA2

Study Overview
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Brief Summary
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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
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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.

Official Title
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Management of Intrapartum Glycemia in Gestational Diabetic Mothers: A Randomized Controlled Trial

Conditions
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Pregnancy, Gestational Diabetes Mellitus, Class A2, Neonatal Hypoglycemia

Intervention / Treatment
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* Other: Blood sugar check every 2 hours
* Other: Blood sugar check every 4 hours


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Usual care glycemic management arm<br>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<br>* Blood sugar check every 2 hours<br>|
| Active Comparator: More liberalized glycemic management arm<br>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<br>* Blood sugar check every 4 hours<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Initial neonatal glucose post delivery | First blood sugar recorded in newborn after delivery | first 2 hours of life | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neonatal hypoglycemia | Blood glucose levels < 40 mg/dl in the first 4 hours of life or < 45 mg/dl beyond 4 hours of life | 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 | 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 | 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 | 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 | 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 | 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. | Intrapartum | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intrapartum Glycemia, Labor