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Table 7 Profile of PALUFER trial activities evaluating weekly iron supplementation [21]

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

     

- 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

     

- 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

     

-Live births

Gestational age

-

-

Wt, length, HC

-

-Cross-sectional postnatal survey

Infant feeding, morbidity, health visits

Hb, iron biomarkers

-

Wt, length, MUAC

Malaria

  1. Abbreviations: Ht height, Wt weight, HC head circumference, BMI body mass index, MUAC mid-uper arm circumference, T0 temperature, BV bacterial vaginosis, STI sexually transmitted infection, IPTp intermittent preventive treatment for malaria (sulfadoxine-pyrimethamine), HIV human immunodeficiency virus, CRP C-reactive protein, AGP acyl glycol-protein, Hb haemoglobin, RDT rapid diagnostic test for malaria
  2. a Malaria, or other exposures, e.g., vaginal infections including bacterial vaginosis and trichomonas, HIV infection
  3. b Location, marital status, occupation, education, ethnicity, likelihood of migration, socio-economic status
  4. c History of menarche, sexual history, previous pregnancies, live births, stillbirths, sickle cell disease
  5. d Serum ferritin, transferrin receptor, hepcidin, free erythrocyte protoporphyrin, mean corpuscular Hb concentration (MCHC), red cell distribution width
  6. e Including use of nutrition supplements
  7. f Variable frequency dependent on study requirements (weekly supplements for PALUFER trial)
  8. g Questions related to fever, respiratory and gastro-intestinal symptoms, skin rashes, or since previous visit. Includes mortality record
  9. h Sera for vitamin and micronutrient concentrations
  10. i Gestational timing and frequency dependent on study objectives