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

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

Detailed Description
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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.

Official Title
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Intrapartum Maternal Glycemic Control Using Insulin Pump Versus Insulin Drip Cohort Retrospective and Prospective Observational Trial

Conditions
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Pregestational Diabetes

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Insulin pump<br>Women suffering from pregestational diabetes mellitus and being treated with insulin pump during pregnancy and delivery | |
| IV insulin<br>Women suffering from pregestational diabetes mellitus and being treated with insulin sub-cutan (SC) during pregnancy and IV insulin during delivery | |
| Healthy<br>Healthy women accepted for delivery in our institute | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Up to 2 hours postpartum | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Over the course of delivery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Maternal intrapartum glycemic control, Pregestational diabetes