Intrapartum Maternal Glycemic Control Using Insulin Pump Versus Insulin Drip - Cohort Observational Trial

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by Sheba Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT01158040
First received: July 4, 2010
Last updated: July 28, 2010
Last verified: July 2010

July 4, 2010
July 28, 2010
August 2010
August 2012   (final data collection date for primary outcome measure)
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
neonatal hypoglycemia (neonatal capillary blood glucose lower then 40 mg/dL) [ Time Frame: up to 2 hours postpartum ] [ Designated as safety issue: Yes ]
All neonates to mothers who sufferes from diabetes mellitus are being routinely tested for neonatal hypoglycemia in our department.Thier capillary blood glucose level is being tested in the first 2 hours postpartum. Data will be gthered and compared in women being treated with insulin pump durin labor versus women being treatd with IV insulin
Complete list of historical versions of study NCT01158040 on ClinicalTrials.gov Archive Site
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
mean maternal blood glucose during labor [ Time Frame: over the course of delivery ] [ Designated as safety issue: Yes ]
All women who suffers from pregestational diabetes mellitus are being routinely tested for blood glucose levels during delivery in our department. Thier capillary blood glucose level is being tested every 1 hour through the active phase of delivery. Mean maternal blood glucose during partum will be compared in women being treated with insulin pump durin labor versus women being treatd with IV insulin
Not Provided
Not Provided
 
Intrapartum Maternal Glycemic Control Using Insulin Pump Versus Insulin Drip - Cohort Observational Trial
Intrapartum Maternal Glycemic Control Using Insulin Pump Versus Insulin Drip Cohort Retrospective and Prospective Observational Trial

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

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.

Observational
Observational Model: Cohort
Not Provided
Not Provided
Probability Sample

Women suffering from pregestational diabetes mellitus type-1, and are being treated for a minimum of 3 months in the high risk pregnancy clinic in Sheba medical center.

Pregestational Diabetes
Not Provided
  • Insulin pump
    Women suffering from pregestational diabetes mellitus and being treated with insulin pump during pregnancy and delivery
  • IV insulin
    Women suffering from pregestational diabetes mellitus and being treated with insulin sub-cutan (SC) during pregnancy and IV insulin during delivery
  • Healthy
    Healthy women accepted for delivery in our institute

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
88
August 2012
August 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Pregnant women suffering from pregestational diabetes mellitus type-1,
  • Women are being treated for a minimum of 3 months in the high risk pregnancy clinic in Sheba medical center
  • Women are being treated with either insulin pump or SC insulin (basal-bolus)

Exclusion Criteria:

  • Women not compliant to treatment
  • Women not planning their delivery in our institute
Female
18 Years to 50 Years
Yes
Contact: Hagit Shani, MD 972-50-7509442 shani.hagit@gmail.com
Contact: Rakefet Yoeli-Ulman, MD 972-54-6551819 rakefety@bezeqint.net
Israel
 
NCT01158040
SHEBA-10-8014-HS-CTIL
No
Hagit Shani MD, Sheba Medical Center
Sheba Medical Center
Not Provided
Study Director: Eyal Sivan, MD. PROF Sheba Medical Center
Sheba Medical Center
July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP