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

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