Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Other |
Maternal age |
Maternal age (birth date, age) assessed by online questionnaire |
baseline |
|
Other |
Nationality |
Belgium versus other assessed by online questionnaire |
baseline |
|
Other |
Family status |
Family status (living together with or without children, living seperate, living with parents) assessed by online questionnaire |
baseline |
|
Other |
Educational level |
Educational level (until 18 yr, +18yr high school, +18yr university or higher) assessed by online questionnaire |
baseline |
|
Other |
Profession |
Profession (working full/half time, studying, unemployed) assessed by online questionnaire |
baseline |
|
Other |
Marietal status |
Marietal status (married, living together, in a relation, divorced, widow) assessed by online questionnaire |
baseline |
|
Other |
BMI |
body mass index |
baseline |
|
Primary |
Gestational weight gain |
Weight at birth minus weight at start of pregnancy |
Birth |
|
Primary |
Gestational length |
Preterm (<37w of gestation) vs a term (37-42w of gestation) delivery |
Birth |
|
Primary |
Surgical complications during pregnancy |
bowel obstruction, strangulation, internal herniation |
up to birth |
|
Primary |
Gestational diabetes mellitus |
disturbed glucose metabolism |
up to birth |
|
Primary |
Hypertensive disorders |
pregnancy-induced hypertension, (pre-)eclampsia |
up to birth |
|
Primary |
Birth weight |
Weight of newborn baby (<2.5kg small-for-gestational age; >4kg macrosomia) |
Birth |
|
Secondary |
Quality of life assessed by the Moorehead-Ardelt Quality of Life Questinnaire II |
quality of life assessed by the Moorehead-Ardelt Quality of Life Questinnaire II |
preoperatively, postoperatively (6 and 12mo), pregnancy trimester 1 (12w), 2 (20-24w) and 3 (28-32w) and postpartum period (6w and 6 mo) |
|
Secondary |
Breast milk fat content |
Breast milk fat content assessed by the Human Milk Analyzer |
weekly from day 3-4 after delivery until week 6 after delivery |
|
Secondary |
Contraception |
Pattern and duration of menstrual cycle and contraceptive use assessed by a self-developed questionnaire |
baseline, postoperatively (6 and 12mo) |
|
Secondary |
Physical activity |
Level of physical activity (household, work, free time, sports) assessed by the Kaiser Physical Activity Survey |
baseline, postoperatively (6 and 12mo), pregnancy trimester 1 (12w), 2 (20-24w) and 3 (28-32w) and postpartum period (6 mo) |
|
Secondary |
Dietary intake |
Dietary intake assessed by a semi-structured 3 day estimated dietary record method (3 day food diary) |
baseline, postoperatively (6 and 12mo), pregnancy trimester 1 (12w), 2 (20-24w) and 3 (28-32w) and postpartum period (6 mo) |
|
Secondary |
Sleeping habits |
sleeping habits (week and week-end) assessed by a self-developed questionnaire |
baseline, postoperatively (6 and 12mo), pregnancy trimester 1 (12w), 2 (20-24w) and 3 (28-32w) and postpartum period (6 mo) |
|
Secondary |
Breastfeeding practices |
Assessed by a structured questionnaire by Guelinckx et al. (2011): initiation and duration of breastfeeding, exclusively breastfeeing, artificial feeding |
Postpartum period (6mo) |
|
Secondary |
Anxiety |
State and Trait anxiety assessed by the State-Trait Anxiety Inventory |
baseline, postoperatively (6 and 12mo), pregnancy trimester 1 (12w) and 3 (28-32w) and postpartum period (6w and 6 mo) |
|
Secondary |
Depression |
depressive feelings assessed by the Edinburgh Postnatal Depression Scale; |
baseline, postoperatively (6 and 12mo), pregnancy trimester 1 (12w) and 3 (28-32w) and postpartum period (6w and 6 mo) |
|
Secondary |
Alcohol use |
drinking habits assessed by the Alcocol Abuse Disorder Identification Test (AUDIT-c) |
baseline, postoperatively (6 and 12mo), pregnancy trimester 1 (12w), 2 (20-24w) and 3 (28-32w) and postpartum period (6 mo) |
|
Secondary |
Smoking habits |
Smoking habits (amount of sigarets, changes during pregnancy) assessed by a self-developed questionnaire |
baseline, postoperatively (6 and 12mo), pregnancy trimester 1 (12w), 2 (20-24w) and 3 (28-32w) and postpartum period (6 mo) |
|
Secondary |
Sexuality |
Sexual activity is assessed by a self-developed questionnaire |
baseline, postoperatively (6 and 12mo) |
|
Secondary |
Total blood count |
red blood cells, hematocrit, hemoglobin, MCV, MCH, MCHC assessed by venipuncture |
baseline, postoperatively (6 and 12mo), pregnancy trimester 1 (12w) and 2 (20-24w) and postpartum period (6w) |
|
Secondary |
Vitamin A |
Vitamin A serum level assessed by venipuncture |
baseline, postoperatively (6 and 12mo), pregnancy trimester 1 (12w) and 2 (20-24w) and postpartum period (6w) |
|
Secondary |
25-OH-vitamin D |
Vitamin 25-OH-vitamin D serum level assessed by venipuncture |
baseline, postoperatively (6 and 12mo), pregnancy trimester 1 (12w) and 2 (20-24w) and postpartum period (6w) |
|
Secondary |
vitamin K1 |
Vitamin K1 serum level assessed by venipuncture |
baseline, postoperatively (6 and 12mo), pregnancy trimester 1 (12w) and 2 (20-24w) and postpartum period (6w) |
|
Secondary |
Vitamin B-12 |
Vitamin B12 serum level assessed by venipuncture |
baseline, postoperatively (6 and 12mo), pregnancy trimester 1 (12w) and 2 (20-24w) and postpartum period (6w) |
|
Secondary |
Folate |
Folate (serum and red blood cells) assessed by venipuncture |
baseline, postoperatively (6 and 12mo), pregnancy trimester 1 (12w) and 2 (20-24w) and postpartum period (6w) |
|
Secondary |
Coagulation |
prothrombin time, activated partial tromboplastin time and coagulation factors assessed by venipuncture |
baseline, postoperatively (6 and 12mo), pregnancy trimester 1 (12w) and 2 (20-24w) and postpartum period (6w) |
|
Secondary |
Glucose |
Fasten glucose level assessed by venipuncture |
baseline, postoperatively (6 and 12mo), pregnancy trimester 1 (12w) and 2 (20-24w) and postpartum period (6w) |
|
Secondary |
Zinc |
Zinc serum level assessed by venipuncture |
baseline, postoperatively (6 and 12mo), pregnancy trimester 1 (12w) and 2 (20-24w) and postpartum period (6w) |
|
Secondary |
Anemia |
Iron, ferritin, transferrin (saturation) levels assessed by venipuncture |
baseline, postoperatively (6 and 12mo), pregnancy trimester 1 (12w) and 2 (20-24w) and postpartum period (6w) |
|
Secondary |
Breast milk protein content |
Breast milk fat protein assessed by the Human Milk Analyzer |
weekly from day 3-4 after delivery until week 6 after delivery |
|
Secondary |
Breast milk carbohydrate content |
Breast milk carbohydrate content assessed by the Human Milk Analyzer |
weekly from day 3-4 after delivery until week 6 after delivery |
|
Secondary |
Breast milk energy content |
Breast milk energy content assessed by the Human Milk Analyzer |
weekly from day 3-4 after delivery until week 6 after delivery |
|
Secondary |
Mode of delivery |
vaginal, cesarean section, instrumental delivery |
Birth |
|
Secondary |
Apgar score |
Apgar score (appearance, pulse, grimase response, activity, respiration) assessed by the medical staff |
Birth (2-5-10 minutes) |
|
Secondary |
Body weight |
Weight measured by the medical staff to 1) calculate the body mass index and 2) to report weight loss (after surgery) or weight gain (during pregnancy) |
baseline, post-operatively (3w, 3, 6 and 12mo), pregnancy trimester 1 (12w), 2 (20-24w), and 3 (28-32w) and the postpartum period (6w and 6mo) |
|