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

Sheba Medical Center88 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Pregestational Diabetes

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Sheba Medical Center

Ramat Gan, Israel

Outcomes

Primary Outcomes

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

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

Time frame: Up to 2 hours postpartum

Secondary Outcomes

Mean maternal blood glucose during labor

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

Time frame: Over the course of delivery

Central Contacts

Hagit Shani, MD

CONTACT

972-50-7509442 shani.hagit@gmail.com

Rakefet Yoeli-Ulman, MD

CONTACT

972-54-6551819 rakefety@bezeqint.net

Data from ClinicalTrials.gov

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