Gestational Diabetes Mellitus, Type II Diabetes Mellitus
Conditions
Keywords
intrapartum, glycemic control, diabetes, insulin
Brief summary
This study will determine whether rotating intravenous (IV) fluid is better than receiving insulin to control a baby's blood sugar after delivery in laboring women with diabetes. A computer will choose the method of controlling the participant's blood sugar while they are in labor.
Detailed 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. 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.
Interventions
OTHERRotating fluids protocol
IV fluids at a rate of 100-150 ml/hr will be administered: * For blood glucose \< 100 mg/dL or less: IV fluids with 5% dextrose * For blood glucose between 101-140 mg/dL: IV fluids without 5% dextrose * For blood glucose \> 140 mg/dL on two consecutive occasions: insulin infusion protocol (Study arm 2)
Regular insulin at 1 unit/ml AND IV fluids at a rate of 100-150 ml/hr will be administered: * For blood glucose \< 80 mg/dL: No insulin AND IV fluids with 5% dextrose * For blood glucose 80-100 mg/dL: Insulin at 0.5 U/hr AND IV fluids with 5% dextrose * For blood glucose 101-140 mg/dL: Insulin at 1.0 U/hr AND IV fluids with 5% dextrose * For blood glucose 141-180 mg/dL: Insulin at 1.5 U/hr AND IV fluids with 5% dextrose * For blood glucose 181-220 mg/dL: Insulin at 2.0 U/hr AND IV fluid without dextrose * For blood glucose \> 220 mg/dL: Insulin at 2.5 U/hr AND IV fluids without dextrose
Sponsors
Geisinger Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Randomized controlled trial
Eligibility
Sex/Gender
FEMALE
Age
14 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Pregnant women with Type II diabetes mellitus or GDM controlled with insulin and/or hypoglycemic medication (GDMA2) * Singleton pregnancies * Gestational age between 37 0/7 weeks and 40 0/7 weeks * Planned delivery at a Geisinger Medical Center (GMC) or Geisinger Wyoming Valley (GWV) * English or Spanish speaking * Anticipated delivery at ≥ 4 hours from randomization (e.g., cervical dilation at ≤ 7 cm at time of randomization)
Exclusion criteria
* Women with Type 1 diabetes mellitus or use of insulin pump * Evidence of diabetic ketoacidosis at time of admission for delivery * Multifetal gestation * Gestational age \< 37 0/7 weeks or \> 40 0/7 weeks * Non-English or Non-Spanish speaking * Anticipated delivery \< 4 hours from randomization (e.g., cervical dilation \> 7 cm at time of randomization, first cesarean delivery of the day) * Oral corticosteroid use within 48 hours of planned delivery * Antenatal corticosteroid use within 7 days of admission for delivery * Delivery planned outside of GMC or GWV * Fetal demise * Prenatal diagnosis of lethal fetal anomaly * Active infection or immunocompromised state (e.g., HIV/AIDS, active malignancy, use of immunosuppressant medication) at time of admission for delivery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Neonatal blood glucose value | Within 2 hours of life | Neonatal blood glucose value from birth to 2 hours of life |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean neonatal blood glucose value | First 24 hours of life | Average of neonatal blood glucose values from birth to 24 hours of life |
| Incidence of maternal hypoglycemia | During labor (average time 24 hours) | Blood glucose value \< 50 mg/dL without symptoms OR Blood glucose value \< 70 mg/dL with symptoms such as perspiration, palpitations, tremor, weakness, anxiety |
| Mean intrapartum maternal blood glucose value | During labor (average time 24 hours) | Average of maternal blood glucose values during labor |
| Maternal blood glucose value before delivery | Within one hour of delivery | Blood glucose value |
| Incidence of composite neonatal outcome | First 24 hours of life until discharge (average time 21 days) | Neonatal hypoglycemia, NICU admission, neonatal hyperbilirubinemia, and neonatal respiratory distress syndrome |
Countries
United States
Outcome results
None listed