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Table 1 Recommendations for reporting anti-malarial drug safety in pregnancy in efficacy studies

From: Methodology of assessment and reporting of safety in anti-malarial treatment efficacy studies of uncomplicated falciparum malaria in pregnancy: a systematic literature review

Report the following:
 Participants’ background
  History of multiple miscarriages or stillbirths
  History of preterm birth (< 37 weeks)
  History of low birth weight (< 2500 g)
  Chronic comorbidity (such as hypertension, diabetes mellitus, HIV and tuberculosis) depending on the prevalence in the area
  Suggested risk factors include smoking status, alcohol consumption, other local social drugs, history of non-malaria febrile illnesses, concomitant medications, consanguinity, nutritional status and socioeconomic status (marital status and educational status)
 Haematology
  Haematinics (iron, folate) use: dose, date
  Haematological measurements: haemoglobin/haematocrit and date
 Fetal loss
  Define miscarriage and stillbirth
  Differentiate intrapartum and antepartum stillbirth
 Preterm birth
  Preterm birth should be clearly defined using standard definitions (preferably WHO)
 Anthropometric assessment of infant
  Use standard methods for measurement of birthweight, birth length, head circumference and for quality control of these measurements
  Describe minimal precision of body weight/length scale
  Control anthropometric outcomes by gestational age and sex. International standard of anthropometric outcomes is available (e.g. INTERGROWTH-21st)
  Include normal singleton live births in summary anthropometric reporting
  Separate reporting and analysis of multiple pregnancy, e.g. twins
  Record the time interval between birth and anthropometric measurement
 Congenital abnormality
  Report details of congenital abnormality applying systematic International Classification of Diseases (ICD) coding
  Assess cardiac auscultation repeatedly
 Growth and development
  Assess growth and development of child to 1 year (optional)
  Use standard referenced developmental assessment (optional)
 Mortality
  Report both overall mortality and malaria-related mortality
  Report maternal death
  Define perinatal mortality, early neonatal mortality and neonatal mortality. e.g. WHO definition