| For all infants |
| Primary outcome | Death prior to hospital discharge |
| For infants born before 32 weeks’ gestation |
| Key secondary outcomes | Death (at any time during follow-up) Severe intraventricular haemorrhage on cranial ultrasound (grade 3–4) All grades of intraventricular haemorrhage on cranial ultrasound Necrotising enterocolitis ≥grade 2 (or trialist definition) Late-onset sepsis (where possible defined as clinical sepsis >72 hours after birth) Patent ductus arteriosus requiring treatment (medical and/or surgical) Chronic lung disease (at 36 weeks’ postmenstrual age or trialist defined) Blood transfusion (yes/no)
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| Other secondary outcomes | Death (within 7 days) Other forms of white matter brain injury (eg, periventricular leukomalacia, porencephaly) Respiratory support (mechanical ventilation, CPAP, low nasal flow oxygen) Duration of respiratory support Supplemental oxygen at 36 weeks Retinopathy of prematurity requiring treatment (medical and/or surgical) Drug treatment for hypotension (yes/no) Blood transfusion (number, volume) Hypothermia on admission to neonatal unit Haemoglobin Haematocrit Polycythaemia Jaundice requiring treatment Birth weight Length of stay in NICU/SCU Length of stay in hospital Apgar scores at 1 min and 5 min Long-term developmental disability (assessed using the Bayley III, and/or other tools):
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| For infants born at or after 32 weeks’ gestation |
| Key secondary outcomes | Death at any time (during follow-up) Admission to NICU Blood transfusion (any, number, volume)
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| Other secondary outcomes | Death (within 7 days) Haemoglobin Haematocrit Jaundice requiring treatment Length of stay in NICU/SCU Length of stay in hospital Duration of respiratory support (mechanical ventilation, CPAP, low flow nasal oxygen) Chronic lung disease Late-onset sepsis (>72 hours after birth) Patent ductus arteriosus requiring treatment (medical and/or surgical) Drug treatment for hypotension Hypothermia on admission to neonatal unit or postnatal ward Apgar score at 1 min and 5 min Long-term developmental disability (assessed using the Bayley III, and/or other tools):
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| For all women |
| Secondary outcomes | Maternal death Postpartum haemorrhage Postpartum sepsis requiring treatment Manual removal of placenta Retained placenta Not breastfeeding when baby discharged from hospital Postnatal depression Blood transfusion
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| Covariates/subgroups |
| Participant-level characteristics |
| | Gestation at birth Type of pregnancy: singleton; multiple Maternal age Mode of birth: caesarean before onset of labour; caesarean after onset of labour; vaginal Onset of labour: spontaneous onset or spontaneous prelabour ruptured membranes; not spontaneous onset or spontaneous prelabour ruptured membranes; not known whether spontaneous onset of labour or spontaneous prelabour ruptured membranes Type of breathing onset: spontaneous breathing onset; supported lung aeration (ventilation); unknown Time of breathing onset relative to cord clamping: before cord clamping/milking; after cord clamping/milking; unknown Sex (male, female, uncertain/other) Ethnicity (trialist defined) Small for gestational age (trialist defined): yes/no Maternal antenatal/intrapartum/postpartum sepsis requiring treatment (trialist defined): yes/no Assessed as needing resuscitation and/or stabilisation (yes/no) Type of uterotonic drug (if any)
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| Hospital/trial-level characteristics |
| | Highest level of neonatal unit available at site: NICU, neonatal unit (some capacity to provide ventilation), special care baby unit (no ventilation available), no neonatal unit or special care baby unit Planned timing of uterotonic drug: before cord clamping; after/at cord clamping; timing mixed or not known Planned position of the baby relative to the placenta while cord intact: level with placenta (between level of woman’s bed and her abdomen/anterior thigh); more than 20 cm below level of placenta; position mixed or not known Need for immediate resuscitation at birth: infants requiring immediate resuscitation at birth excluded; infants requiring immediate resuscitation at birth included; unclear whether infants requiring immediate resuscitation at birth included or excluded Type of consent: waiver of consent; deferred consent; informed consent or assent; type of consent unclear Study year
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