Effect of Intrapartum Glucose With Compared to Without Constant Intravenous Insulin on Neonatal Hypoglycemia Among Diabetic Women. A Randomized Controlled Trial
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
This study aims to examine the effect of intrapartum treatment of diabetic women with combined glucose and constant insulin infusion compared to glucose alone on the incidence of neonatal hypoglycemia. Pregnant women with diabetes in pregnancy will be randomly divided during labor to 2 groups: group 1, will receive intravenous glucose with constant insulin infusion; group 2 will receive intravenous glucose alone. The primary outcome is the incidence of neonatal hypoglycemia.
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: t
View:
• \>37 weeks gestation
• gestational diabetes mellitus according to Carpenter and Coustan
• pregestational diabetes mellitus
Locations
Other Locations
Israel
HaEmek medical center
RECRUITING
Afula
Contact Information
Primary
Gali Gali, MD
galit_ga@clalit.org.il
972-4-6494035
Backup
Raed Salim, MD
salim_ra@clalit.org.il
972-4-6494355
Time Frame
Start Date: 2017-10-31
Estimated Completion Date: 2023-12-31
Participants
Target number of participants: 200
Treatments
Active_comparator: glucose solution and insulin
Participants will receive intravenous saline solution boosted with 5% glucose + 8 units regular insulin in a rate of 125 mL/h.
Active_comparator: glucose solution only
Participants will receive intravenous saline solution boosted with 5% glucose in a rate of 125 mL/h.
Related Therapeutic Areas
Sponsors
Leads: HaEmek Medical Center, Israel
Collaborators: Holy Family Hospital, Nazareth, Israel