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

• Conditions: Pregestational Diabetes

• Registration Number: NCT01158040
• Lead Sponsor: Sheba Medical Center

Brief Summary

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

Detailed 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 Timeline

• Status Verified: 2010-07
• Study First Submitted: 2010-07-04
• Study First Submitted QC: 2010-07-07
• Study First Posted: 2010-07-08
• Last Update Submitted: 2010-07-28
• Last Update Posted: 2010-07-29
• Study Start: 2010-08
• Primary Completion: 2012-08
• Study Completion: 2012-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 88

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Neonatal hypoglycemia (neonatal capillary blood glucose lowers then 40 mg/dL)	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

Secondary Outcome Measures

Name	Time	Method
Mean maternal blood glucose during labor	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

Trial Locations

Locations (1)

Sheba Medical Center; 🇮🇱 Ramat Gan, Israel