| Outcome Measures: |
Primary: A composite of: pregnancy loss, preterm birth, birth injury, moderate/severe respiratory distress, neonatal hypoglycemia, and NICU admission > 24 hours., conception to 28 days after birth | Secondary: Large for gestational age (LGA) infants, Defined as greater than the 90th percentile for weight, based on the National canadian fetal growth standards for singleton boys and girls., Up to 24 hours after birth|Pregnancy loss, Spontaneous abortion defined as death of a fetus at \<20 weeks gestation; Stillbirth defined as death of a fetus with a birth weight ≥ 500g or at ≥ 20 wks gestational age regardless of birth weight; Neonatal death defined as death of a live born infant within the first 28 days of life or prior to hospital discharge, whichever is later., Up to 40 weeks gestation|Preterm birth, Birth \< 37 weeks gestation, Up to 37 weeks gestation|Respiratory distress, Given surfactant via an endotracheal tube and/or requiring assisted positive pressure ventilation within 72 hours after birth., within 72 hours after birth|Neonatal hypoglycemia, A plasma glucose \<2.6 mmol/L on one or more occasions, starting at 30-60 minutes after birth, and necessitating intravenous dextrose within the first 48 hours of life., NICU admission >24 hours|NICU admission >24 hours, Admission to a neonatal intensive or special care unit for \> 24 hours during the initial hospitalization after birth, NICU admission >24 hours|Cord blood gases pH <7.0, Within 4 hours of birth|Hyperinsulinemia as measured by elevated cord blood C-peptide, A cord serum C-peptide value \> 1.7 ug/L (which is \>90th percentile of values for the total cohort of participants in the HAPO trial) will be defined as hyperinsulinemia., Within 4 hours of birth|Maternal glycemic control as measured by HbA1c and capillary glucose measurements., Gestational age at testing will be recorded. All downloaded glucose results will be transmitted on a regular basis to a central site for future analysis. Monthly correlations will be done with the laboratory during routine monthly blood draws., Up to 40 weeks gestation|Maternal hypoglycemia, Maternal hypoglycemia defined as mild (\<3.6, symptomatic and asymptomatic or requiring treatment), or severe (loss of consciousness or confusion requiring assistance) will be documented at each visit., Up to 40 weeks gestation|Maternal weight gain, The first and last weight will be obtained at the first and last visit in pregnancy, whether they be done by the endocrinologist, family physician or obstetrician., Up to 40 weeks gestation|Maternal insulin doses, Maternal insulin doses (overall amount and number of patients that are taking 'high' insulin doses defined as 2 Units/kg or more per day), Up to 40 weeks gestation|Pre-eclampsia, and/or gestational hypertension, Gestational hypertension: New onset of hypertension in pregnancy ≥ 20 weeks gestation in a woman with previously normal blood pressure, defined as diastolic blood pressure of ≥ 90 mmHg, taken on 2 occasions or placed on antihypertensive medication and without proteinuria. Pre-eclampsia: please refer to protocol for definition, Up to 40 weeks gestation|Sepsis, A positive blood and/or cerebral spinal fluid culture during the neonatal hospital stay., Up to 28 days after birth|Hyperbilirubinemia, Significant jaundice was present based on bilirubin levels requiring treatment with phototherapy\> 6 continuous hours, or an exchange transfusion, or receiving intravenous gamma globulin, or requiring readmission into hospital during the first 7 days of life., First 7 days of life|Number of hospitalizations, Number of hospitalizations prior to admission for delivery and the duration of hospital stays for the mother prior to admission for delivery and associated with delivery., Up to 40 weeks gestation|Rate of caesarean-section, Up to 40 weeks gestation|Duration of hospital stay for infant., Duration of hospital stay for infant associated with his/her birth until the first discharge home, Up to 28 days after birth|Fetal fat mass, Fetal fat mass compared with women treated with insulin plus placebo, Up to 7 days after birth|Birth Injury, Defined as any of the following: spinal cord injury, basal skull fracture or depressed skull fracture, clavicular fracture, long bone fracture, subdural or intracerebral hemorrhage or any kind, Up to 7 days after birth|Shoulder dystocia, Documentation of any shoulder dystocia in the delivery records, plus 3 or more of the following: McRoberts maneuver, suprapubic maneuver, episiotomy, delivery of the posterior arm, Woods maneuver, Rubins maneuver, All fours Gaskins maneuver, intentional fracture of the clavicle, and/or Zavenelli maneuver., At delivery
|
