Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Birth weight |
|
approx 20 weeks after enrollment (within 48 hours) |
|
Primary |
Newborn length |
|
At 1 week of age |
|
Primary |
Length for age Z-score (LAZ) at 18 months of age |
|
12 months after enrollment (age 18 months) |
|
Secondary |
Anthropometric status (weight, BMI, mid upper arm circumference and triceps and sub-scapular skin-fold thickness) |
|
at ~ 36 wk gestation and 6 months postpartum |
|
Secondary |
Gestational age at delivery, proportion of preterm deliveries |
|
At delivery |
|
Secondary |
Proportion of low birth weight babies |
|
At birth |
|
Secondary |
Anaemia and iron status (Hb, ZPP, transferrin receptor), other micronutrient status (vitamin A, B-vitamins, zinc), malarial antigen |
|
At ~ 36 wk gestation and 6 mo postpartum |
|
Secondary |
Red blood cell essential fatty acid status |
|
At ~ 36 wk gestation |
|
Secondary |
Urinary iodine |
|
At ~ 36 wk gestation |
|
Secondary |
Total plasma cholesterol concentration |
|
At ~ 36 wk gestation |
|
Secondary |
Basal salivary cortisol concentration |
|
At ~ 28 and ~ 36 wk gestation |
|
Secondary |
Blood pressure |
|
At 36 wk gestation |
|
Secondary |
Breast milk composition (essential fatty acids, vitamin A, B-vitamins) |
|
At 6 mo postpartum |
|
Secondary |
Depressive symptoms (which may be related to essential fatty acid status) |
|
At 4 weeks and at 6 months postpartum |
|
Secondary |
Incidence of febrile malaria episodes |
|
During pregnancy |
|
Secondary |
Peripheral blood malaria parasitaemia |
|
At 32 wk gestation and at delivery |
|
Secondary |
Placental malaria histology |
|
At delivery |
|
Secondary |
Evidence of defined bacteria in the chorionic membranes at delivery (quantitative DNA amplification method) |
|
At birth |
|
Secondary |
Prevalence of Neisseria gonorrhoea, Chlamydia trachomatis, in swab samples taken from maternal uterine cervix(qualitative DNA amplification method) |
|
At one week after delivery |
|
Secondary |
Prevalence of bacterial vaginosis, Trichomonas vaginalis, or candidiasis, in swab samples taken from maternal vagina(direct microscopy) |
|
At one week after delivery |
|
Secondary |
Malaria immunity |
|
At enrolment, at ~ 36 wk gestation, and 6 months post-partum |
|
Secondary |
Anthropometric infant status (weight, length, head circumference and mid upper arm circumference) |
|
At 7 days of age and at 6, 12 and 18 months of age. After the intervention at 24 and 30 months and at 10 y of age. |
|
Secondary |
Infant anaemia and iron status (Hb, ZPP), micronutrient (vitamin A, B-vitamins) and essential fatty acids status, evidence of acute inflammation (CRP, AGP), and malarial antigen and microscopy |
|
At 6 and 18 months of age |
|
Secondary |
Incidence of neonatal hospitalizations |
|
At or before age 28 days |
|
Secondary |
Clinical morbidity |
|
Between 0 and 18 months of age |
|
Secondary |
Child feeding practices and maternal report of child sleep patterns |
|
At 6, 12 and 18 months of age |
|
Secondary |
Antibody response to measles vaccination |
|
At 18 months of age |
|
Secondary |
Malaria immunity |
|
At 6 and 18 months of age |
|
Secondary |
Basal salivary cortisol concentration |
|
At 6, 12 and 18 months of age |
|
Secondary |
Cortisol response to acute stress |
|
At 6 and 18 months of age |
|
Secondary |
Achievement of five motor milestones and four other developmental milestones |
|
From 0 to 18 mo |
|
Secondary |
Neurobehavioral development |
|
At 18 months of age |
|
Secondary |
Incidence of serious adverse events |
|
During pregnancy and 18 months of infant follow-up |
|
Secondary |
Prevalence of maternal periodontitis |
|
At one week after delivery |
|
Secondary |
Maternal cognition |
Measured with several different tests |
6 months after delivery |
|
Secondary |
Mother - child interaction |
Measured with a number of observational tests and questionnaires |
6 months after delivery |
|
Secondary |
The composition of intestinal microbiota |
Done with 16s sequencing, from stored stool samples |
1, 2, 3, 4, 5, 6, 9, 12, 15, 18, 21, 24, 27, and 30 months of child age |
|
Secondary |
diastolic blood pressure |
Mobil-o-Graph blood pressure monitoring system |
Child is 10 years |
|
Secondary |
central blood pressure |
Mobil-o-Graph blood pressure monitoring system |
Child is 10 years |
|
Secondary |
pulse rate |
Mobil-o-Graph blood pressure monitoring system |
Child is 10 years |
|
Secondary |
vascular resistance |
Mobil-o-Graph blood pressure monitoring system |
Child is 10 years |
|
Secondary |
plasma concentration of glucose |
Cobas c702 machine |
Child is 10 years |
|
Secondary |
plasma concentration of cholesterol |
Cobas c702 machine |
Child is 10 years |
|
Secondary |
plasma concentration of HDL/LDL cholesterol |
Cobas c702 machine |
Child is 10 years |
|
Secondary |
plasma concentration of triglycerides |
Cobas c702 machine |
Child is 10 years |
|
Secondary |
plasma concentration of c-reactive protein |
Cobas c702 machine |
Child is 10 years |
|
Secondary |
plasma concentration of alkaline phosphatase |
Cobas c702 machine |
Child is 10 years |
|
Secondary |
plasma concentration of aspartyl alanine transferase |
Cobas c702 machine |
Child is 10 years |
|
Secondary |
plasma concentration of potassium |
Cobas c702 machine |
Child is 10 years |
|
Secondary |
plasma concentration of sodium |
Cobas c702 machine |
Child is 10 years |
|
Secondary |
plasma concentration of urate |
Cobas c702 machine |
Child is 10 years |
|
Secondary |
Spirometry measures functional volume of the lungs |
Global Lung Function Initiative standards, Medikro pro spirometry |
Child is 10 years |
|
Secondary |
asthma symptoms |
ISAAC questionnaire |
Child is 10 years |
|
Secondary |
allergy symptoms |
ISAAC questionnaire |
Child is 10 years |
|
Secondary |
neural functioning |
EEG |
Child is 10 years |
|
Secondary |
processing speed |
EEG |
Child is 10 years |
|
Secondary |
oculomotor reaction time |
eye-tracking |
Child is 10 years |
|
Secondary |
academic achievement |
Early Grade Mathematics Assessment, EGMA |
Child is 10 years |
|
Secondary |
height |
|
Child is 10 years |
|
Secondary |
sitting height |
|
Child is 10 years |
|
Secondary |
weight |
|
Child is 10 years |
|
Secondary |
head circumference |
|
Child is 10 years |
|
Secondary |
mid-upper arm circumference |
|
Child is 10 years |
|
Secondary |
body composition |
Tanita MC-780 MAS |
Child is 10 years |
|