Secondary outcome | Measurement variable | Participant-level analysis metrica | Method of aggregation for each probiotic/placebo treatment arm |
---|---|---|---|
Demographic information | History of atopy (mother) | Baseline value | Proportion of participants with positive history of atopy at baseline |
History of atopy (father) | Baseline value | Proportion of fathers with positive history of atopy at baseline | |
History of psychiatric disorders | Baseline value | Proportion of participants with positive history of depression or anxiety disorder at baseline | |
Number of previous pregnancies | Baseline value | Mean (SD) at baseline | |
Age | Baseline value | Mean (SD) at baseline | |
Number of previous children | Baseline value | Mean (SD) at baseline | |
Type of marital status | Baseline value | Proportion of participants in relationship (i.e. married/living together) at baseline | |
Employment status | Baseline value | Proportion of participants employed at baseline | |
Education level | Baseline value | Proportion of participants with primary school, lower secondary vocational education, lower secondary education, higher secondary education, middle level vocational education or tertiary education at baseline | |
Ethnicity | Baseline value | Proportion of participants whose fathers and mothers were born in the Netherlands at baseline | |
Current psychiatric diagnosis | Baseline value | Proportion of participants with diagnosis depression, anxiety disorder, none or other at baseline | |
Breastfeeding | Exclusive or partial breastfeeding | End value | Proportion of participants with exclusive breastfeeding and partial breastfeeding at 4 weeks postpartum (t4) |
Maternal medication use and treatment | Number of non- pharmacological treatment(s) (i.e. cognitive behavioral therapy, psychotherapy, rapid eye-movement therapy, psychosocial support) | Baseline value; change from baseline to t1 | Proportion of participants receiving non-pharmacological treatment at baseline; proportion of participants starting new non-pharmacological treatment between t0 and t1 |
Number of pharmacological treatment(s) for depression or anxiety | Baseline value; change from baseline to t1 | Proportion of participants receiving antidepressants, anxiolytics, other; proportion of participants starting new pharmacological treatment(s) for depression or anxiety between t0 and t1 | |
Type of general medication used | Baseline value; change from baseline to t1 | Proportion of participants taking medication (other than pharmacological treatment for depression or anxiety); proportion of participants who start taking new medication between t0 and t1 | |
Type of food supplement(s) used | Baseline value; change from baseline to t1 | Proportion of participants taking food supplements; proportion of participants who start taking new food supplements during the intervention period | |
Type of vitamin(s) used | Baseline value; change from baseline to t1 | Proportion of participants taking vitamins; proportion of participants who start taking new vitamins during the intervention period | |
Maternal lifestyle | Smoking (yes/no) | Baseline value | Proportion of participants smoking |
Alcohol (yes/no) | Baseline value | Proportion of participants drinking alcohol | |
Pregnancy characteristics | Occurrence of infections during pregnancy | Final value | Proportion of participants reporting infections (i.e. influenza, fever, diarrhea) throughout the study |
Delivery characteristics | Gestational age | Final value | Gestational age at delivery |
Pregnancy and delivery complications | Number of pregnancy and delivery complications (i.e. hypertensive disorders of pregnancy (pregnancy induced hypertension, preeclampsia, eclampsia, hemolysis - elevated liver enzymes - low platelet count (HELLP) syndrome), gestational diabetes mellitus, preterm birth, cesarean section, retention placentae, hemorrhage postpartum, small or large for gestational age (birth weight < p10 or > p90), puerperal fever, prolonged labor, premature rupture of membranes) | Final value | Proportion of participants diagnosed with pregnancy or delivery complications at delivery |
Infant antibiotic use | Number of antibiotics used | Final value | Proportion of infants receiving antibiotics during first month of life |
Depression | Edinburgh Postnatal Depression Scale (EPDS) score | Change from baseline to t1 and t4 | Mean (SD)/median (IQR) |
Depression/cognitive reactivity | Leiden Index of Depression Sensitivity-Revised (LEIDS-R) score | Change from baseline to t1 and t4 | Mean (SD)/median (IQR) |
Pregnancy related anxiety | Pregnancy Related Anxiety Questionnaire-Revised (PRAQ-R) score | Change from baseline to t1 | Mean (SD)/median (IQR) |
General anxiety | State-trait Anxiety Inventory (STAI-S) score | Change from baseline to t1 and t4 | Mean (SD)/median (IQR) |
Pregnancy-related daily hassles | Pregnancy-related daily hassles (PES) score | Change from baseline to t1 and t4 | Mean (SD)/median (IQR) |
General daily hassles/stress | Daily Hassles List (APL) score | Change from baseline to t1 and t4 | Mean (SD)/median (IQR) |
Mother to infant bonding | Maternal Antenatal Attachment Scale (MAAS) score | Change from baseline to t1 | Mean (SD)/median (IQR) |
Maternal Postnatal Attachment Scale (MPAS) | Change from t3 to t4 | Mean (SD)/median (IQR) | |
Biological samples | Maternal fecal samples (microbiota) | Change from baseline to t1 | Relative abundance and diversity of bacteria at phylum up to genus level |
Maternal vaginal samples (microbiota) | Change from baseline to t1 | Relative abundance and diversity of bacteria at phylum up to genus level | |
Maternal hair (cortisol) | Change from baseline to t1 | Mean (SD)/median (IQR) | |
Fecal sample infant (microbiota) | Change from t3 to t4 | Relative abundance of bacteria at phylum up to genus level | |
Cry diary | Duration (hours/minutes) of crying during 3 days | Final value | Mean (SD)/median (IQR) |