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Clinical Trial Summary

The purpose of this study is to compare intrapartum glycemic control using insulin pump versus intravenous (IV) insulin administration.


Clinical Trial Description

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. ;


Study Design

Observational Model: Cohort


Related Conditions & MeSH terms


NCT number NCT01158040
Study type Observational
Source Sheba Medical Center
Contact Hagit Shani, MD
Phone 972-50-7509442
Email shani.hagit@gmail.com
Status Not yet recruiting
Phase N/A
Start date August 2010
Completion date August 2012

See also
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Completed NCT02793505 - Safety of Metformin in Pregnancy N/A
Not yet recruiting NCT05152589 - Maternal Diabetes in Newborns With Hearing Loss
Not yet recruiting NCT01255384 - Possible Epigenetic Changes in Offspring of Women With Pregestational and Gestational Diabetes N/A