Table 4 Maternal measurements and data collection time points
Variables | Research visit (in weeks) | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
Pregnancy | Delivery | 1 | 6 | 10 | 14 | 24 | 36 | 48 | 72 | 96 | |
A. Maternal life style | |||||||||||
1. Current alcohol use | ✓ | ✓ | ✓ | ✓ | |||||||
2. Smoking | |||||||||||
3. Living under same roof with spouse/partner | ✓ | ✓ | ✓ | ✓ | |||||||
4. Current marital/ domestic violence | ✓ | ✓ | ✓ | ✓ | |||||||
5. Physical activity | ✓ | ✓ | ✓ | ||||||||
B. Household factors | |||||||||||
1. Household numbers & composition | ✓ | ✓ | ✓ | ✓ | |||||||
2. Number of rooms available | ✓ | ✓ | ✓ | ✓ | |||||||
3. Main source of drinking water | ✓ | ✓ | ✓ | ✓ | |||||||
4. Main source of energy for cooking (household pollution) | ✓ | ✓ | ✓ | ✓ | |||||||
5. Main place for cooking | ✓ | ✓ | ✓ | ✓ | |||||||
6. Sleeping arrangements | ✓ | ✓ | ✓ | ✓ | |||||||
Water and sanitation | ✓ | ✓ | ✓ | ✓ | |||||||
7. Presents of family diarrhoeal diseases | ✓ | ✓ | ✓ | ✓ | |||||||
C. Nutritional factors | |||||||||||
1. Maternal number of meal a day | ✓ | ✓ | ✓ | ✓ | |||||||
2. Household meals eaten per day | ✓ | ✓ | ✓ | ✓ | |||||||
3. Food frequency questionnaire | ✓ | ✓ | ✓ | ✓ | |||||||
4. Food security tool | ✓ | ✓ | ✓ | ✓ | |||||||
5. Perceived food allergens/ adverse reactions | ✓ | ✓ | ✓ | ✓ | |||||||
6. 24 h food recall | ✓ | ✓ | ✓ | ||||||||
7. Craved foods | ✓ | ||||||||||
8. Any disorder related to food mastication and/ or retention | ✓ | ✓ | ✓ | ✓ | |||||||
9. Bristol stool chart | ✓ | ✓ | |||||||||
D. General health | |||||||||||
1. Use of condom and sexual behaviour | ✓ | ✓ | ✓ | ✓ | |||||||
2. Past and current methods of contraception used | ✓ | ✓ | ✓ | ✓ | ✓ | ||||||
3. 7Health seeking behaviour | ✓ | ✓ | ✓ | ✓ | |||||||
4. Tb symptoms checklist for active Tb | ✓ | ✓ | ✓ | ✓ | ✓ | ||||||
5. History of Tb disease and treatment | ✓ | ✓ | ✓ | ||||||||
6. Current and past other opportunistic infections | ✓ | ✓ | ✓ | ✓ | |||||||
7. Past and current symptoms of sexually transmitted infections | ✓ | ✓ | ✓ | ✓ | ✓ | ||||||
8. Past or current hypertension | ✓ | ✓ | ✓ | ✓ | ✓ | ||||||
9. Past or current stress | ✓ | ✓ | ✓ | ✓ | ✓ | ||||||
10. Baby blues assessment tool | ✓ | ||||||||||
11. Depression | ✓ | ✓ | ✓ | ✓ | |||||||
12. Hospitalisation in the past 3 months | ✓ | ✓ | ✓ | ✓ | |||||||
13. Sick clinic visits during index pregnancy | ✓ | ||||||||||
14. Vaccinations during index pregnancy | ✓ | ||||||||||
15. Timing of antenatal booking, number of subsequent visits | ✓ | ||||||||||
16. Knowledge of pregnancy disorders that warrant immediate hospitalization | ✓ | ||||||||||
17. Concurrent medication and supplements | ✓ | ✓ | ✓ | ✓ | ✓ | ||||||
18. Concurrent herbal and traditional medication | ✓ | ✓ | ✓ | ✓ | ✓ | ||||||
19. Use of sexual enhancing herbs/ substances | ✓ | ✓ | ✓ | ||||||||
20. History of routine dental or pap smear checks | ✓ | ✓ | ✓ | ||||||||
21. Anthropometric measurements (BMI, MUAC)) | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | |||
22. Systolic and diastolic BP and pulse measurements | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | |||
23. General physical examination (e.g. oedema) | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | |||
24. Last date of menstruation | |||||||||||
E. HIV-infected only: ART use, duration, disclosure & adherence | |||||||||||
1. ART use regimen, duration, switching of regimens | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
2. Presence of adequate supplies | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
3. ART side effects | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
4. Non-adherence issues | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
5. Disclosure of HIV status | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
6. Stigma experience | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
7. WHO clinical staging for the HIV-infected | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
F. Clinical data collected at delivery | |||||||||||
1. Mode of delivery | ✓ | ||||||||||
2. Duration of labour | ✓ | ||||||||||
3. Live and stillbirths | |||||||||||
4. Term/ preterm delivery | |||||||||||
5. Pregnancy outcome | ✓ | ||||||||||
6. Length of stay in hospital/ clinic after delivery | ✓ | ||||||||||
7. Obstetric related complications | |||||||||||
8. Time of previous ART intake for HIV-infected mothers | ✓ | ||||||||||
G. Biological specimen collection in the 3rd trimester | |||||||||||
1. Stool | ✓ | ||||||||||
i) Intestinal helminths testing | |||||||||||
ii) Microbiome profiles (sub-studies) | |||||||||||
2. Urine i) Urinalysis and storage microbiome | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
3. Blood | |||||||||||
i) Serology, molecular genetics, HIV, CMV, HBV, syphilis | ✓ | ✓ | |||||||||
ii) TB QuantiFERON gold (sub-study) | ✓ | ✓ | |||||||||
iii) Full blood counts | ✓ | ✓ | |||||||||
iv) Infant vaccine titres | ✓ | ✓ | |||||||||
v) Biochemistry | ✓ | ||||||||||
a. Dyslipidaemia | ✓ | ✓ | |||||||||
b. Kidney function tests | ✓ | ✓ | |||||||||
c. Liver function tests | ✓ | ✓ | |||||||||
i) Vitamin D | ✓ | ✓ | |||||||||
ii) HbA1c, random glucose | ✓ | ||||||||||
iii) Cytokine profiles | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
iv) CD4 counts | ✓ | ✓ | |||||||||
v) HIV RNA load | ✓ | ✓ | ✓ | ||||||||
vi) CMV DNA load | ✓ | ✓ | |||||||||
vii) HBV DNA load | |||||||||||
viii) Host genetic susceptibility | ✓ | ||||||||||
ix) Immunometabolomics | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
H. Delivery bio-specimens | |||||||||||
1. Placental pathology in latent Tb (sub-study), microbiome | ✓ | ||||||||||
2. Amniotic-fluid co-infections, alcohol levels, microbiome | ✓ | ||||||||||
3. Breast milk (lipid profiles and microbiome, CMV viral load), microbiome | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | |
I. Spouse/ intimate partner factors (as reported by mothers) | |||||||||||
1. Age | ✓ | ||||||||||
2. Occupation | ✓ | ✓ | |||||||||
3. Previous marital status | ✓ | ||||||||||
4. HIV status, ART usage | ✓ | ✓ | |||||||||
5. Participation in pregnancy, ante | ✓ | ✓ | |||||||||
6. Participation in child care | ✓ | ✓ | ✓ | ||||||||