Intrapartum Maternal Glycemic Control Using Insulin Pump Versus Insulin Drip - Cohort Observational Trial
Recruitment status was Not yet recruiting
The purpose of this study is to compare intrapartum glycemic control using insulin pump versus intravenous (IV) insulin administration.
|Study Design:||Observational Model: Cohort|
|Official Title:||Intrapartum Maternal Glycemic Control Using Insulin Pump Versus Insulin Drip Cohort Retrospective and Prospective Observational Trial|
- Neonatal hypoglycemia (neonatal capillary blood glucose lowers then 40 mg/dL) [ Time Frame: Up to 2 hours postpartum ] [ Designated as safety issue: Yes ]All neonates to mothers who suffer from diabetes mellitus are being routinely tested for neonatal hypoglycemia in our department. Their capillary blood glucose level is being tested in the first 2 hours postpartum. Data will be gathered and compared in women being treated with insulin pump during labor versus women being treated with IV insulin
- Mean maternal blood glucose during labor [ Time Frame: Over the course of delivery ] [ Designated as safety issue: Yes ]All women suffering from pregestational diabetes mellitus are being routinely tested for blood glucose levels during delivery in our department. Their capillary blood glucose level is being tested every 1 hour throughout the active phase of delivery. Mean maternal blood glucose during partum will be compared in women being treated with insulin pump during labor versus women being treated with IV insulin
|Study Start Date:||August 2010|
|Estimated Study Completion Date:||August 2012|
|Estimated Primary Completion Date:||August 2012 (Final data collection date for primary outcome measure)|
Women suffering from pregestational diabetes mellitus and being treated with insulin pump during pregnancy and delivery
Women suffering from pregestational diabetes mellitus and being treated with insulin sub-cutan (SC) during pregnancy and IV insulin during delivery
Healthy women accepted for delivery in our institute
Intrapartum maternal glycemic control in women suffering from pregestational diabetes mellitus type 1 will be evaluated and compared in the 3 study groups. Maternal and neonatal capillary blood glucose will be measured. All women suffering from diabetes mellitus and all neonates to hyperglycemic mothers are being tested for their blood glucose in our institute. Measurements' data will be collected. The primary outcome of the study is the number of neonatal hypoglycemic events (neonatal blood glucose < 40mg/dL). All women participating in the study will be treated according to the standard accepted protocol for "the treatment of pregestational diabetes during labor" in our institute. The research will not include new treatments or equipment.
The study is a cohort prospective and retrospective observational study in the tertiary center - Sheba medical center.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01158040
|Contact: Hagit Shani, MDemail@example.com|
|Contact: Rakefet Yoeli-Ulman, MDfirstname.lastname@example.org|
|Sheba Medical Center||Not yet recruiting|
|Ramat Gan, Israel, 52621|
|Contact: Hagit Shani, MD 972-50-7509442 email@example.com|
|Contact: Rakefet Yoeli-Ulman, MD 972-54-6551819 firstname.lastname@example.org|
|Principal Investigator: Hagit Shani, MD|
|Study Director:||Eyal Sivan, MD. PROF||Sheba Medical Center|