This study is investigating whether insulin treatment with the insulin pump or with multiple daily injections (MDI) gives better outcomes for mother and baby in pregnant women with pregestational diabetes. Participants will be randomized to use either the insulin pump or MDI.
Primary outcome is a composite of Cesarian section, instrumental delivery, maternal hypertension, LGA infant, neonatal hypoglycemia or SCN admission.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
2
subjects in the experimental arm will administer insulin using a pump
Subjects will continue with usual insulin injections
Jim Pattison Outpatient Care and Surgery Centre
Surrey, British Columbia, Canada
B.C. Women's Hospital
Vancouver, British Columbia, Canada
Composite obstetrical/perinatal endpoint consisting of specific elements (see description)
Composite obstetrical/perinatal endpoint consisting of one or more of pre-eclampsia, primary caesarian section, pre-term delivery, spontaneous abortion, termination for congenital anomaly or chromosomal abnormality, perinatal mortality, large-for-gestational age, shoulder dystocia, birth injury, major congenital anomaly, neonatal hypoglycemia, jaundice requiring phototherapy, or admission to neonatal intensive care nursery.
Time frame: Up to 42 weeks
Mean maternal HbA1c during pregnancy
HbA1c will be measured at least every three months to provide information about overall glycemic control
Time frame: up to 42 weeks
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