Intrapartum Maternal Glycemic Control Using Insulin Pump Versus Insulin Drip - Cohort Observational Trial
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|ClinicalTrials.gov Identifier: NCT01158040|
Recruitment Status : Unknown
Verified July 2010 by Sheba Medical Center.
Recruitment status was: Not yet recruiting
First Posted : July 8, 2010
Last Update Posted : July 29, 2010
|Condition or disease|
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 Type :||Observational|
|Estimated Enrollment :||88 participants|
|Official Title:||Intrapartum Maternal Glycemic Control Using Insulin Pump Versus Insulin Drip Cohort Retrospective and Prospective Observational Trial|
|Study Start Date :||August 2010|
|Estimated Primary Completion Date :||August 2012|
|Estimated Study Completion Date :||August 2012|
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
- Neonatal hypoglycemia (neonatal capillary blood glucose lowers then 40 mg/dL) [ Time Frame: Up to 2 hours postpartum ]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 ]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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|