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

Sheba Medical Center

Status

Unknown

Conditions

Pregestational Diabetes

Study type

Observational

Funder types

Other

Identifiers

NCT01158040

SHEBA-10-8014-HS-CTIL

Details and patient eligibility

About

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

Full 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.

Enrollment

88 estimated patients

Sex

Female

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

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