Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
time in range |
time between 63-140mg/dl (pregnancy glycemic target range) |
from 14 weeks to 36 weeks |
|
Secondary |
time in range during the night |
time in range (63-140mg/dl) from midnight till 6am |
from 14 weeks to 36 weeks |
|
Secondary |
time below low day and night |
time <63mg/dl day and night |
from 14 weeks to 36 weeks |
|
Secondary |
overnight time low |
time <63mg/dl from midnight till 6am |
from 14 weeks to 36 weeks |
|
Secondary |
time in range during the day |
time in range (63-140mg/dl) during the day |
from 14 weeks to 36 weeks |
|
Secondary |
time in range early pregnancy |
time in range (63-140mg/dl) 9-12 weeks |
from 9 weeks to 12 weeks |
|
Secondary |
time in range during each trimester |
time in range (63-140mg/dl) during each trimester |
from 9 weeks to 36 weeks |
|
Secondary |
HbA1c during each trimester |
HbA1c (% and mmol/mol) during each trimester |
from 9 weeks to 36 weeks |
|
Secondary |
mean glucose |
mean glucose based on CGM |
from 14 weeks to 36 weeks |
|
Secondary |
time above target (140mg/dl) |
time >140mg/dl |
from 14 weeks to 36 weeks |
|
Secondary |
time above target (180mg/dl) |
time >180mg/dl |
from 14 weeks to 36 weeks |
|
Secondary |
time below target (50mg/dl) |
time <50mg/dl |
from 14 weeks to 36 weeks |
|
Secondary |
time below target (54mg/dl) |
time <54mg/dl |
from 14 weeks to 36 weeks |
|
Secondary |
duration of hypoglycemia |
low blood glucose index |
from 14 weeks to 36 weeks |
|
Secondary |
time in nonpregnant target range |
time 70-180mg/dl |
from 14 weeks to 36 weeks |
|
Secondary |
CGM compliance |
% of time use of CGM |
from 14 weeks to 36 weeks |
|
Secondary |
insulin dose |
total insulin dose |
from 14 weeks to 36 weeks |
|
Secondary |
glycemic variability |
standard deviation glucose values based on CGM |
from 14 weeks to 36 weeks |
|
Secondary |
variation glucose values |
coefficient of variation based on CGM |
from 14 weeks to 36 weeks |
|
Secondary |
MAGE |
mean amplitude of glucose variations based on CGM |
from 14 weeks to 36 weeks |
|
Secondary |
nocturnal hypoglycemia |
glucose <50mg/dl from 23-07hour |
from 9 weeks to 36 weeks |
|
Secondary |
severe hypoglycemia |
hypoglycemia requiring third-part assistance |
from 9 weeks to 36 weeks |
|
Secondary |
rate of diabetic keto-acidosis |
metabolic keto-acidosis with decreased ph and/or decreased bicarbonate in blood |
from 9 weeks to 36 weeks |
|
Secondary |
gestational duration |
duration of pregnancy (weeks) |
delivery |
|
Secondary |
duration hospitalization delivery |
length of hospital stay (days) |
delivery |
|
Secondary |
type of labor |
spontaneous, induced or cesarean section before labor |
delivery |
|
Secondary |
type of delivery |
vaginal, forceps or vacuum, cesarean section during labor or planned cesarean section |
delivery |
|
Secondary |
rate of preterm delivery |
delivery <37 weeks |
delivery |
|
Secondary |
rate of gestational hypertension |
blood pressure of 140/90mmHg or higher starting after 20 weeks of gestation |
from 20 weeks to delivery |
|
Secondary |
rate of worsening of chronic hypertension |
blood pressure of 140/90mmHg or higher start is present before 20 weeks of gestation |
from 9 weeks to delivery |
|
Secondary |
rate of preeclampsia |
onset of new hypertension and proteinuria and/or end-organ dysfunction after 20 weeks of gestation |
from 20 weeks to delivery |
|
Secondary |
rate of eclampsia |
generalized convulsions and/or coma |
from 20 weeks to delivery |
|
Secondary |
rate of HELLP syndrome |
hemolysis, elevated liver enzymes and a low platelet count |
from 20 weeks to delivery |
|
Secondary |
rate of IUGR |
intra-uterine growth restriction |
from 20 weeks to delivery |
|
Secondary |
rate of fetal malformation |
congenital malformation |
up to 24 weeks |
|
Secondary |
rate of miscarriage |
fetal loss <20 weeks gestations |
<20 weeks |
|
Secondary |
rate of termination of pregnancy |
induced abortion |
up to 24 weeks |
|
Secondary |
rate of stillbirth |
mors in utero >20 weeks |
>20 weeks |
|
Secondary |
rate of neonatal death |
death <1 months after delivery |
1 month after delivery |
|
Secondary |
sex of infant |
boy or girl |
delivery |
|
Secondary |
birth weight |
birth weight (Kg and g) |
delivery |
|
Secondary |
rate of shoulder dystocia |
one or both of a baby's shoulders get stuck inside the mother's pelvis during labor. |
delivery |
|
Secondary |
rate of birth trauma |
fracture, damage to nerves... |
delivery |
|
Secondary |
rate of respiratory distress |
respiratory failure or distress |
delivery |
|
Secondary |
rate of hyperbilirubinaemia |
hyperbilirubinaemia with need of treatment with phototherapy |
delivery |
|
Secondary |
rate of macrosomia |
birth weight >4Kg |
delivery |
|
Secondary |
rate with high birth weight |
birth weight >4.5Kg |
delivery |
|
Secondary |
rate of LGA infant (lage for gestational age) |
gestational age adjusted birth weight >90th percentile according to the standardized Flemish birth charts adjusted for parity and sex |
delivery |
|
Secondary |
rate of SGA infant (small for gestational age) |
gestational age adjusted birth weight <10th percentile according to the standardized Flemish birth charts adjusted for parity and sex |
delivery |
|
Secondary |
number with very large gestational age infants |
gestational age adjusted birth weight >97th percentile according to the standardized Flemish birth charts adjusted for parity and sex |
delivery |
|
Secondary |
cord blood ph |
cord blood gas ph |
delivery |
|
Secondary |
rate of neonatal hypoglycemia |
neonatal hypoglycemia requiring intravenous dextrose |
up to 5 days after delivery |
|
Secondary |
rate of NICU admission |
Neonatal intensive care unit (NICU) admission defined as requiring a duration of at least 24 h |
up to 30 days after delivery |
|
Secondary |
duration NICU admission |
duration of NICU admission (days or weeks) |
up to 30 days after delivery |
|
Secondary |
rate of fetal hyperinsulinemia |
cord blood c-peptide |
delivery |
|
Secondary |
skinfolds newborn |
sum of skinfolds (triceps, scapula and flank) |
up to 3 days after delivery |
|
Secondary |
neonatal fat mass |
fat mass calculated by the formula of Catalano |
up to 3 days after delivery |
|
Secondary |
number with composite neonatal outcome |
pregnancy loss (miscarriage, still birth or neonatal death), LGA, respiratory distress syndrome, birth trauma, shoulder dystocia, neonatal hypoglycemia and NICU admission |
delivery |
|