Intrapartum Glycemic Control With Insulin Infusion Versus Rotating Fluids
Completed · Not applicable
Conditions studied: Type II Diabetes Mellitus, Gestational Diabetes Mellitus
In brief
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.
Key facts
- Study ID
- NCT03912363
- Run by
- Geisinger Clinic
- People needed
- 114
- Starts
- 2019-11-01
- Expected to finish
- 2025-03-01
- Last updated by the study team
- 2025-06-12
Who can join
Age: 14 and older, up to 50. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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
Where it is running
- Geisinger — Danville, Pennsylvania, United States
- Geisinger Wyoming Valley — Wilkes-Barre, Pennsylvania, United States
Full record on ClinicalTrials.gov
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