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. 2021 Sep 30;11(9):e047133. doi: 10.1136/bmjopen-2020-047133

Table 6.

Group 1 and group 2 measurements

Phase Measurements group 1 Measurements group 2
Baseline Routine care clinical record (MCR) abstraction:
  • Booking visit

    • Obstetric and neonatal history

    • Medical and general history

    • Physical examinations (height, MUAC, weight, blood pressure)

    • Screening tests (syphilis, HIV, urine, Rhesus, haemoglobin)

    • Gestational age assessment

Routine care clinical record (MCR) abstraction:
  • Booking visit

    • Obstetric and neonatal history

    • Medical and general history

    • Physical examinations (height, MUAC, weight, blood pressure)

    • Screening tests (syphilis, HIV, urine, Rhesus, haemoglobin)

    • Gestational age assessment


Study-specific data collection
  • Questionnaires

    • Demographics

    • Clinical (including obstetric) history

    • HIV care and ART use

    • Tuberculosis care

    • Substance use.

  • Physical examination (standardised measures)

    • Ultrasound

    • Anthropometry

    • Blood pressure

  • Specimen collection

    • Phlebotomy.

Follow-up Routine care clinical record abstraction:
MCR
  • Follow-up antenatal visit notes including blood pressure readings

  • Obstetric notes

    • Initial labour assessment (general, abdominal and vaginal examinations)

    • Clinical notes during labour (second – fourth stage)

    • Newborn assessments (birth outcome, gender, birth anthropometry and delivery complications)

    • Postpartum notes

Routine care clinical record abstraction:
MCR
  • Follow-up antenatal visit notes including blood pressure readings

  • Obstetric notes

    • Initial labour assessment (general, abdominal and vaginal examinations)

    • Clinical notes during labour (second–fourth stage)

    • Newborn assessment (birth outcome, gender, birth anthropometry and delivery complications)

    • Postpartum notes


Infant Road-to-Health Booklet
  • Vaccinations

  • Chemoprophylaxis use

  • HIV PCR testing


Study-specific data collection
Maternal
  • Questionnaires

    • ART use and adherence, medical and obstetric events

    • Labour and delivery (at <7 days only)

  • Physical examination (standardised measures)

    • Anthropometry (height, weight and MUAC)

    • Blood Pressure

    • Ultrasound (at 28 week visit only)

  • Specimen collection

    • Phlebotomy for storage of plasma and PBMCs

    • Placenta and cord blood (at delivery)

    • Storage of cord blood PBMCs

    • Isolation of PBMCs from decidua membrane for T cells and macrophage subsets identification

    • Tissue section formalin fixing and paraffin embedding for histopathology


Infant
  • Questionnaires

    • Medical events

    • Feeding practices

    • Development assessment (at 12 months only)

  • Physical examination (standardised measures)

    • Anthropometry (weight, length, head circumference and MUAC)

  • Specimen collection

    • DBS (at 10 weeks only)

    • Phlebotomy for storage of plasma and PBMCs (at 12 months only)

DBS, dried blood spots; MCR, maternity case record; MUAC, mid-upper arm circumference; PBMC, peripheral blood mononuclear cell.;