Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Primary |
Changes in the insulin need during pregnancy |
The insulin dosage (IU/ml) in two weeks sets |
from 5-10 gestational weeks until the delivery |
|
| Secondary |
Blood glucose balance during pregnancy HbA1c |
HbA1c (mmol/mol) |
from gestational weeks 5 until the delivery |
|
| Secondary |
Blood glucose balance during pregnancy AVG, SD, CV |
mean blood glucose (mmol/l) level, standard deviation (SD) and the coefficient of variation of the blood glucose levels |
from gestational weeks 5 until the delivery |
|
| Secondary |
Change in the weight |
Weight gain (g) during pregnancy |
from gestational weeks 5 until the delivery |
|
| Secondary |
Change in the blood pressure |
Blood pressure (mmHg) |
from gestational weeks 5 until the delivery |
|
| Secondary |
Incidence of pre-eclampsia |
Incidence of pre-eclampsia (%) |
from gestational weeks 20 until the delivery |
|
| Secondary |
Incidence hepatogestosis |
Incidence hepatogestosis (%) |
from gestational weeks 20 until the delivery |
|
| Secondary |
Pregnancy complications |
Incidence proteinuria (mg/mmol or mg/d) |
from gestational weeks 5 until the delivery |
|
| Secondary |
macrosomia |
estimated fetal weight in ultrasound (grams) |
from gestational weeks 20 until the delivery |
|
| Secondary |
Pregnancy complications |
incidence of miscarriage (intrauterine death before 22 weeks of gestation or fetal weigth under 500g) (%) |
12-22 weeks of gestation |
|
| Secondary |
Pregnancy complications |
incidence of intrauterine death (intrauterine death after 22 weeks of gestation or fetal weigth over 500g) (%) |
22-40 weeks of gestation |
|
| Secondary |
Thigh fractional volume ultrasound |
Fetal weight estimation (g) is specified by thigh fractional volume ultrasound program |
from gestational weeks 20 until delivery |
|
| Secondary |
Rate of the caesarean sections |
Rate of the caesarean sections (%) |
The delivery |
|
| Secondary |
Labour |
rate of spontaneous delivery (%) |
The delivery |
|
| Secondary |
Rate of the operative vaginal deliveries |
Rate of the operative vaginal deliveries (%) |
The delivery |
|
| Secondary |
Rate of the shoulder dystocia |
Rate of the shoulder dystocia (%) |
The delivery |
|
| Secondary |
Labor complications |
rate of induced delivery (%) |
The delivery |
|
| Secondary |
Rate of the perineal tears |
Rate of the perineal tears (%) |
The delivery |
|
| Secondary |
Postpartum bleeding |
postpartum bleeding (ml) |
The delivery |
|
| Secondary |
Newborn variables (gestational age) |
Rate of the premature deliveries (=deliveries before 37 weeks of gestation) (%) |
After the delivery |
|
| Secondary |
Newborn variables |
weight of the newborn (g) |
After the delivery |
|
| Secondary |
Newborn outcome |
Acidosis of the newborn (pH) |
After the delivery |
|
| Secondary |
Newborn outcome (intensive care) |
The need of NICU (neonatal intensive care unit) treatment (days) |
After the delivery |
|
| Secondary |
Newborn outcome (hypoglycemia) |
The occurrence of hypoglycemia (=plasma glucose under 2.6mmol/l or usage of iv glucose infusion) (%) |
After the delivery |
|
| Secondary |
Newborn outcome (Erb's) |
Incidence of the Erb's paresis (%) |
After the delivery |
|
| Secondary |
Cost benefit calculations (sick leaves) |
The need of sick leaves during pregnancy (days) |
from gestational weeks 12 until delivery |
|
| Secondary |
Cost benefit calculations (visits to maternity outpatient clinic or internal medicine policlinic) |
The need of polyclinical controls during pregnancy (number of visits/pregnancy) |
14-40 weeks of gestation |
|
| Secondary |
Cost benefit calculations (hospitalization) |
The need of hospitalization during pregnancy (days/pregnancy) |
14-40 weeks of gestation |
|
| Secondary |
Cost benefit calculations (all outpatient visits after delivery ) |
The need of policlinical controls of the diabetic mother after the delivery (number of visits) |
One year after the delivery |
|
| Secondary |
Cost benefit calculations (hospitalization after delivery, all departments) |
The need of hospitalization of the diabetic mother after the delivery (days) |
Up to one year after the delivery |
|
| Secondary |
Cost benefit calculations (all hospitalization of the child) |
The need of hospitalization of the child (days) |
Until the age of one year |
|
| Secondary |
Cost benefit calculations (all policlinical controls of the child) |
The need of policlinical controls of the child (number of visits) |
Until the age of one year |
|
| Secondary |
high sensitive-CRP |
high sensitive-CRP (mg/l) |
7-10, 26-28 and 34-36 weeks of gestation |
|
| Secondary |
lipids |
cholesterol, high density lipoprotein, low density lipoprotein, triglyserids (mmol/l) |
7-10, 26-28 and 34-36 weeks of gestation |
|
| Secondary |
Inflammatory markers |
adiponectin, leptin, resistin, IL-6, TNF-a (pg/ml) |
7-10, 26-28 and 34-36 weeks of gestation |
|
