From: Perspectives on the design and methodology of periconceptional nutrient supplementation trials
Study contact | Health history and assessment | Haematology | Biochemistry | Anthropometry | Infection and inflammation screena |
---|---|---|---|---|---|
Screening | Demographicsb | - | - | - | - |
Randomisation | Reproductive,c general health, blood pressure, temperature, dietary,e drugs | Sera for iron biomarkers,d Hb if pallor or symptomatic | Blood for sera and genotype | Wt, Ht, BMI, MUAC | Malaria if symptomatic, vaginal, STI (syndromic) |
Non-pregnant cohort | Â | Â | Â | Â | Â |
- Weekly visitsf | T0 C and morbidity,g side effects, compliance, | - | - | - | RDT for malaria if symptoms/febrile |
- Cross-sectional survey | T0 C and morbidity, side effects | - | - | - | All for malaria microscopy |
- Participant unscheduled visits | T0 C and morbidity, side effects | - | - | - | If symptoms |
- End assessment survey | T0 C and morbidity, side effects | Hb, iron biomarkers | Nutritional biomarkersh | Wt, Ht, MUAC | Malaria RDT and microscopy, BV, CRP, vaginal microbiome and lactoferrin, trichomonas |
-Focus groups/interviews | Knowledge and acceptability | - | - | - | - |
Pregnant cohort | Â | Â | Â | Â | Â |
- First AN attendance i at 13–16 wks | T0 C and morbidity, ultrasound, blood pressure, drugs (IPTp), supplement, compliance, side effects | Hb, iron and folate biomarkers | Urine glucose and protein | Wt, Ht, MUAC | Malaria RDT and microscopy, CRP and AGP, BV, HIV, STI (syndromic), vaginal lactoferrin and microbiome, trichomonas |
- Second AN attendance at 32–36 wks | T0 C and morbidity, blood pressure, drugs (IPTp) | Hb if pallor or symptomatic | Urine glucose and protein | Wt, Ht | Vaginal lactoferrin and microbiome, other infections if symptoms |
- Unscheduled visits | T0 C and morbidity | Hb if pallor or symptomatic | - | Wt | Other infections if symptoms |
- Delivery | T0 C and morbidity, stillbirths | - | - | Wt | Placental histology for chorioamnionitis and malaria |
Infant follow-up | Â | Â | Â | Â | Â |
-Live births | Gestational age | - | - | Wt, length, HC | - |
-Cross-sectional postnatal survey | Infant feeding, morbidity, health visits | Hb, iron biomarkers | - | Wt, length, MUAC | Malaria |