Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Gestational Diabetes Mellitus
  • Type II Diabetes Mellitus
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Randomized controlled trialMasking: None (Open Label)Primary Purpose: Prevention

Participation Requirements

Age
Between 14 years and 50 years
Gender
Only males

Description

Diabetes complicates 6-9% of all pregnancies. Of those pregnancies, 90% of pregnant diabetics have gestational diabetes mellitus (GDM), while the remainder of patients have pre-existing diabetes mellitus (DM). Maternal hyperglycemia has a negative impact on maternal and fetal/neonatal health. Advers...

Diabetes complicates 6-9% of all pregnancies. Of those pregnancies, 90% of pregnant diabetics have gestational diabetes mellitus (GDM), while the remainder of patients have pre-existing diabetes mellitus (DM). Maternal hyperglycemia has a negative impact on maternal and fetal/neonatal health. Adverse neonatal outcomes include birth injuries, respiratory distress, and metabolic derangements such as hypoglycemia. The incidence of neonatal hypoglycemia is higher in pregnancies complicated by pre-existing DM (24-48%) when compared to patients with GDM (16-19%). Neonatal hypoglycemia causes immediate and long-term morbidity. Treatment of hypoglycemia may require admission to the Neonatal Intensive Care Unit (NICU). The severity and duration of neonatal hypoglycemia raises concern for permanent neurologic damage to the neonate. Even transient episodes of neonatal hypoglycemia have been associated with neurodevelopmental impairment. It is imperative that measures be taken in diabetic mothers (both pre-existing and gestational) to minimize the risk of neonatal hypoglycemia. While antepartum maternal glucose control remains an important factor in preventing neonatal complications, prevention of maternal hyperglycemia during the intrapartum period has been shown to reduce the risk of neonatal hypoglycemia. Therapies utilized for maternal intrapartum glycemic control across academic centers in the United States include the use of insulin and rotation of intravenous (IV) fluids. Although used in clinical practice for intrapartum glycemic control, the impact of rotating IV fluids on neonatal blood glucose is unknown. The potential for using rotating IV fluids to control intrapartum blood glucose has several advantages over using insulin for optimization of blood glucose. There is minimal risk of maternal hypoglycemia using IV fluids when compared to insulin therapy. There is also less risk of medication error. IV fluids are easily administered as they do not require separate peripheral access and are easily accessible on a Labor and Delivery (L&D) unit. The investigators propose a randomized controlled trial (RCT) to assess the effect of maternal intrapartum glycemic control with rotating IV fluids compared to insulin infusion on neonatal blood glucose levels within two hours of birth. The investigators hypothesize neonates born to mothers managed by rotating fluids will have higher neonatal blood glucose levels (closer to normal range) within two hours of birth compared to neonates born to mothers managed by insulin infusion.

Tracking Information

NCT #
NCT03912363
Collaborators
Not Provided
Investigators
Principal Investigator: Michael J Paglia, MD, PhD Geisinger Clinic