TABLE 1.

Outcome Measures Included in the Systematic Review

Outcome Measures
Primary outcomes
Neonatal	Survival to discharge from hospital; survival without moderate to severe neurodevelopmental impairment in early childhood (see definitions below); severe IVH: ultrasound diagnosis grades III and IV (Papile et al45)
Maternal	PPH: clinically estimated blood loss of at least 500 mL, or as defined by the trial authors
Key secondary outcomes
Neonatal	Chronic lung disease (supplemental oxygen at 36 wk’ postmenstrual age)46; NEC (Bell ≥stage II)47; hyperbilirubinemia requiring phototherapy; peak hematocrit or hemoglobin concentrations at 24 h after birth; peak hematocrit or hemoglobin concentrations at 7 d after birth
Infant and early childhood	Moderate to severe neurodevelopmental impairment in early childhood; components of moderate to severe neurodevelopmental impairment in early childhood including: (1) cerebral palsy, (2) significant mental developmental delay (Bayley Scales of Infant Development Mental Developmental Index <70; Bayley48), (3) legal blindness (<20/200 visual acuity), and (4) hearing deficit (aided or <60 dB on audiometric testing)
Maternal	Severe PPH: clinically estimated blood loss of at least 1000 mL; maternal death or severe morbidity composite (eg, organ failure, ICU admission, or as defined by trial authors); use of therapeutic uterotonic agent/s; blood transfusion; manual removal of the placenta; additional treatment of PPH (uterine tamponade, embolization); postpartum infection
Other secondary outcomes
Neonatal	Condition at birth: Apgar score at 5 min of age; resuscitation (need for positive pressure ventilation, intubation, chest compressions); temperature <36° within 1 h of birth
	Respiratory: respiratory distress syndrome; respiratory support (use of mechanical ventilation or CPAP); duration of respiratory support (days of mechanical ventilation or CPAP); surfactant treatment; home oxygen
	Cardiovascular: treatment of patent ductus arteriosus (medical and/or surgical); inotropic support for hypotension during the first 24 h of life; lowest mean arterial blood pressure in the first 12 h of life
	Central nervous system: any IVH (grade 1 or greater) on cranial ultrasound, as per Papile classification45; periventricular leukomalacia (any grade [grade ≥1], on basis of ultrasound or MRI49)
	Gastrointestinal: NEC requiring surgery
	Hematologic: Blood transfusion (any); total No. blood transfusions
	Other: late sepsis (positive blood or fungal culture after 3 d of life); retinopathy of prematurity in infants examined (all stages [stage ≥1] and severe [defined as stage ≥3])50; treatment of retinopathy of prematurity; length of infant stay in NICU (d); fully breastfed or mixed feeding at infant discharge; resource use
Maternal	Maternal death; individual components of severe morbidity (as listed above or as defined by the trial authors); prolonged third stage (>30 min); length of third stage of labor; postnatal anemia (defined by trial authors, absolute or relative drop in hemoglobin); maternal length of hospital stay after birth; mother’s or partner’s views regarding the intervention and control

CPAP, continuous positive airway pressure; PPH, postpartum hemorrhage.